| Primary | Change in Truncal Fat Percentage (Week 34) | Change in Truncal fat percentage was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Percentage of truncal fat | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG0000.49± 3.31
- OG001-2.39± 4.48
- OG002-1.17± 2.89
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| Changes in truncal fat percentage from baseline to the 34 week's measurements was analysed using an analysis of covariance model with treatment, growth hormone deficiency (GHD) onset type, sex, region, diabetes mellitus (DM) and sex by region by DM interaction as factors and baseline as a covariate. The analysis was conducted using a multiple imputation technique where trajectory after a withdrawn subjects last observation was imputed based on data from the placebo arm. | ANCOVA | | =0.0090 | | Treatment difference | -1.53 | | | 2-Sided | 95 | -2.68 | -0.38 | | | | | Superiority |
|
| Secondary | Change in Truncal Fat Percentage (Week 87) | Change in Truncal fat percentage was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Percentage of truncal fat | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Truncal Fat Mass (Week 34) | Change in Truncal fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | grams | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Truncal Fat Mass (Week 87) | Change in Truncal fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | grams | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Truncal Lean Body Mass (Week 34) | Change in Truncal lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | grams | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Truncal Lean Body Mass (Week 87) | Change in Truncal lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | grams | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Total Fat Mass (Week 34) | Change in Total fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | grams | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Total Fat Mass (Week 87) | Change in total fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | grams | | Week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Visceral Adipose Tissue (Week 34) | Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | centimeter square | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Visceral Adipose Tissue (Week 87) | Change in Visceral adipose tissue was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | centimeter square | | Week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Android Fat Mass (Week 34) | Change in Android fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | gram | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Android Fat Mass (Week 87) | Change in Android fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | gram | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Gynoid Fat Mass (Week 34) | Change in Gynoid fat mass was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | gram | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Gynoid Fat Mass (Week 87) | Change in Gynoid fat mass was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | gram | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Appendicular Skeletal Muscle Mass (Week 34) | Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | gram | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Appendicular Skeletal Muscle Mass (Week 87) | Change in Appendicular skeletal muscle mass was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | gram | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Lean Body Mass (Week 34) | Change in Lean body mass was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | gram | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Lean Body Mass (Week 87) | Change in Lean body mass was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | gram | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Bone Mineral Content (Week 87) | Change in Bone mineral content was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | gram | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Bone Mineral Density (Week 87) | Change in Bone mineral density was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | grams per square centimeter | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in IGF-I SDS (Week 34) | Change in insulin-like growth factor (IGF-I) standard deviation scores (SDS) was measured from baseline (week -3) until the end of the main treatment period (week 34). A higher score reflects a better outcome. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Standard deviation score | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in IGF-I SDS (Week 87) | Change in IGF-I SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). A higher score reflects a better outcome. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Standard deviation score | | Week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in IGFBP 3 SDS (Week 34) | Change in insulin like growth factor binding protein 3 (IGFBP 3) SDS was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Standard deviation score | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in IGFBP 3 SDS (Week 87) | Change in IGFBP 3 SDS was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Standard deviation score | | Week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in TRIM-AGHD (Total and Domain Scores) (Week 34) | Change in treatment-related impact measure - adult growth hormone deficiency (TRIM-AGHD) scores (total and domain scores) was measured from baseline (week 0) until the end of the main treatment period (week 34). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome. | Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Scores on a scale | | Week 0, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
|
| Secondary | Change in TRIM-AGHD (Total and Domain Scores) (Week 87) | Change in TRIM-AGHD (total and domain scores) was measured from baseline (week 0) until the end of the extension treatment period (week 87). The TRIM-AGHD questionnaire measured the impact of GH treatment on the functioning and well-being of AGHD patients. The 4 concepts covered by the questionnaire were physical health, energy levels, cognitive ability and psychological health. TRIM-AGHD has 27 items and a total score as well as domain specific scores can be derived. The total score includes all answers that has been used to calculate each of the 4 subdomains. The score ranged from 0 to 100 for 'individual domains' and for the 'total', where a lower score reflected a better outcome. | Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Scores on scale | | week 0, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. |
|
| Secondary | Change in SF-36v2 (Summary and Domain Scores) (Week 34) | SF-36v2â„¢ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. | Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Scores on scale | | Week 0, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | |
|
| Secondary | Change in SF-36v2 (Summary and Domain Scores) (Week 87) | SF-36v2â„¢ questionnaire measured health-related quality of life (HRQoL) on 8 domains (Bodily Pain, General Health, Mental Health, Physical Functioning, Role Emotion, Physical Health, Social Functioning and Vitality) on individual scale ranges. The scores 0-100 (higher scores indicates better HRQoL) from SF-36 were converted to norm-based scores to enable a direct interpretation in relation to distribution of the scores in the 2009 U.S. general population. Mental component summary (MCS) measure is derived from domain scales of vitality, social functioning, role emotional and mental health. Physical component summary (PCS) measure is derived from domain scales of physical functioning, role-physical, bodily pain, and general health. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. A positive change score indicates an improvement since baseline. | Overall number of participants analyzed = full analysis set (FAS) which comprised all randomised participants. Number Analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Score on scale | | week 0, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan |
|
| Secondary | TSQM-9 Scores (Domain Scores) (Week 34) | Scores from the TSQM-9 scale were calculated at the end of the main treatment period (week 34). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100. | Overall number of participants analyzed = FAS. Number analyzed = Number of participants with available data. | Posted | | Mean | Standard Deviation | Scores on a scale | | Week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan |
|
| Secondary | TSQM-9 Scores (Domain Scores) (Week 87) | Scores from the TSQM-9 scale were calculated at the end of the extension treatment period (week 87). The Treatment Satisfaction Questionnaire for Medication - 9 items (TSQM-9) is a generic questionnaire that measures a patients' satisfaction with medication. Items are rated on a 5-point or 7-point scale according to patients' experience with the medication. The items covered are satisfaction with the effect of the medication, convenience and global treatment satisfaction. Each domain is based on 3 questions. The score is calculated in a range from 0 to 100, where a higher score reflects a better outcome. Scores have been summed and then scaled to 0-100. | Overall number of participants analyzed = FAS. Number analyzed = Number of participants with available data. | Posted | | Mean | Standard Deviation | Scores on a scale | | Week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | |
|
| Secondary | Change in Total Cholesterol (Week 34) | Change in Total cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Total Cholesterol (Week 87) | Change in Total cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in HDL-cholesterol (Week 34) | Change in High-density lipoprotein (HDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in HDL-cholesterol (Week 87) | Change in HDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in LDL-cholesterol (Week 34) | Change in Low-density lipoprotein (LDL) cholesterol was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in LDL-cholesterol (Week 87) | Change in LDL-cholesterol was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Triglycerides (Week 34) | Change in Triglycerides was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Triglycerides (Week 87) | Change in Triglycerides was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Hs-CRP (Week 34) | Change in high-sensitivity C-reactive protein (hs-CRP) was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Hs-CRP (Week 87) | Change in hs-CRP was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | mg/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in IL-6 (Week 34) | Change in Interleukin 6 (IL-6) was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | pg/mL | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in IL-6 (Week 87) | Change in IL-6 was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | pg/mL | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Body Weight (Week 34) | Change in body weight was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Kg | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Body Weight (Week 87) | Change in body weight was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | Kg | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Waist Circumference (Week 34) | Change in waist circumference was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | cm | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Waist Circumference (Week 87) | Change in waist circumference was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analysed = number of participants with available data. | Posted | | Mean | Standard Deviation | cm | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Number of Adverse Events (Weeks 0-35) | Number of adverse events from baseline (week 0) until the end of week 35 were reported. This endpoint shows number of treatment-emergent adverse events (TEAEs), including the injection site reactions. | Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product. | Posted | | Number | | Events | | Weeks 0-35 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Number of Adverse Events (Weeks 0-88) | Number of adverse events from baseline (week 0) until the end of week 88 were reported. This endpoint shows the number of TEAEs along with the injection site reactions. | Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product. | Posted | | Number | | Events | | Weeks 0-88 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. |
|
| Secondary | Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-35) | Number of participants with anti-NNC0195-0092 antibodies at week 35 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies. | Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product. | Posted | | Count of Participants | | Participants | | Weeks 0 to 35 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Occurrence of Anti-NNC0195-0092 Antibodies (Weeks 0-88) | Number of participants with anti-NNC0195-0092 antibodies at week 88 was recorded. The numbers presented in this endpoint are the participants that were found to have positive antibodies. | Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product. | Posted | | Count of Participants | | Participants | | Weeks 0 to 88 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. |
|
| Secondary | Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-35) | Incidence of technical complaints were recorded from baseline (week 0) until week 35. | Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product. | Posted | | Number | | Technical complaints | | Weeks 0 to 35 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Incidence of Technical Complaints During Exposure to Trial Product (Weeks 0-88) | Incidence of technical complaints were recorded from baseline (week 0) until week 88. | Overall number of participants analyzed = safety analysis set (SAS) which comprised all randomised participants who received at least one dose of trial product. | Posted | | Number | | Technical complaints | | Weeks 0 to 88 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | |
|
| Secondary | Change in Physical Examination During Exposure to Trial Product (Week 35) | Change in physical examination from baseline (week 0) until the end of the main treatment period (week 35) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation | Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data. | Posted | | Count of Participants | | Participants | | Week 0 and week 35 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
|
| Secondary | Change in Physical Examination During Exposure to Trial Product (Week 88) | Change in physical examination from baseline (week 0) until the end of the extension period (week 88) was reported. Results are presented for the following examinations: 1) Head, neck, eyes and nose 2) Respiratory system (sys.) 3) Cardiovascular sys. 4) Gastrointestinal sys. 5) Musculoskeletal sys. 6) Central & Peripheral nervous sys. 7) Skin 8) Lymph node palpation | Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data. | Posted | | Count of Participants | | Participants | | Week 0 and week 88 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | |
|
| Secondary | Change in Electrocardiogram (ECG) Evaluation During Exposure to Trial Product (Week 35) | Change in Electrocardiogram (ECG) evaluation from baseline (week -3) until the end of the main treatment period (week 35) was reported. | Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data. | Posted | | Count of Participants | | Participants | | Week -3 and week 35 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in ECG Evaluation During Exposure to Trial Product (Week 88) | Change in ECG evaluation from baseline (week 0) until the end of the extension period (Week 88) was reported. | Overall number of participants analyzed = SAS which comprised all randomised participants who received at least one dose of trial product. Number Analyzed = number of participants with available data. | Posted | | Count of Participants | | Participants | | Week -3 and week 88 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. |
|
| Secondary | Change in Diastolic Blood Pressure (Week 35) | Change in diastolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mm Hg | | Week -3, week 35 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Diastolic Blood Pressure (Week 88) | Change in diastolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period week 88. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mm Hg | | Week -3, week 88 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Systolic Blood Pressure (Week 35) | Change in systolic blood pressure was measured from baseline (week -3) until the end of the main treatment period (week 35). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mm Hg | | Week -3, week 35 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Systolic Blood Pressure (Week 88) | Change in systolic blood pressure was measured from baseline (week -3) until the end of the extension treatment period (week 88). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mm Hg | | Week -3, week 88 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Pulse (Week 35) | Change in pulse was measured from baseline (week -3) until the end of the main treatment period (week 35). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | beats/min | | Week -3, week 35 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Pulse (Week 88) | Change in pulse was measured from baseline (week -3) until the end of the extension treatment period (week 88). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | beats/min | | Week -3, week 88 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Haemoglobin (Week 34) | Change in Haemoglobin was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Haemoglobin (Week 87) | Change in Haemoglobin was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Haematocrit (Week 34) | Change in Haematocrit was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | % of red blood cells | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Haematocrit (Week 87) | Change in Haematocrit was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | % of red blood cells | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Erythrocytes (Week 34) | Change in Erythrocytes was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | cells/pL | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Erythrocytes (Week 87) | Change in Erythrocytes was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | cells/pL | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Mean Corpuscular Volume (MCV) (Week 34) | Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | fL | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Mean Corpuscular Volume (MCV) (Week 87) | Change in Mean corpuscular volume (MCV) was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | fL | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 34) | Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Mean Corpuscular Haemoglobin Concentration (MCHC) (Week 87) | Change in Mean corpuscular haemoglobin concentration (MCHC) was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Thrombocytes (Week 34) | Change in Thrombocytes was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Thrombocytes (Week 87) | Change in Thrombocytes was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Leucocytes (Week 34) | Change in Leucocytes was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Leucocytes (Week 87) | Change in Leucocytes was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Alanine Aminotransferase (ALT) (Week 34) | Change in ALT was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Alanine Aminotransferase (ALT) (Week 87) | Change in ALT was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Albumin (Week 34) | Change in Albumin was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Albumin (Week 87) | Change in Albumin was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Alkaline Phosphatase (ALP) (Week 34) | Change in Alkaline phosphatase (ALP) was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Alkaline Phosphatase (AP) (Week 87) | Change in Alkaline phosphatase (AP) was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | Week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Aspartate Aminotransferase (AST) (Week 34) | Change in AST was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Aspartate Aminotransferase (AST) (Week 87) | Change in AST was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | Week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Bilirubin (Week 34) | Change in Bilirubin was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | umol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Bilirubin (Week 87) | Change in Bilirubin was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | umol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Calcium (Week 34) | Change in Calcium was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Calcium (Week 87) | Change in Calcium was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Chloride (Week 34) | Change in Chloride was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Chloride (Week 87) | Change in Chloride was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Creatinine (Week 34) | Change in Creatinine was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | umol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Creatinine (Week 87) | Change in Creatinine was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | umol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Creatine Kinase (Week 34) | Change in Creatine kinase was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Creatine Kinase (Week 87) | Change in Creatine kinase was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Gamma-glutamyl Transferase (GGT) (Week 34) | Change in GGT was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Gamma-glutamyl Transferase (GGT) (Week 87) | Change in GGT was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | U/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Phosphate (Inorganic) (Week 34) | Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Phosphate (Inorganic)(Week 87) | Change in Phosphate (inorganic) was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Potassium (Week 34) | Change in Potassium was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Potassium (Week 87) | Change in Potassium was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Sodium (Week 34) | Change in Sodium was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Sodium (Week 87) | Change in Sodium was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Total Protein (Week 34) | Change in total protein was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Total Protein (Week 87) | Change in total protein was measured from baseline (week -3) until the end of extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | g/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Urea (Week 34) | Change in Urea was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Urea (Week 87) | Change in Urea was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Uric Acid (Week 34) | Change in Uric acid was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | umol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Uric Acid (Week 87) | Change in Uric acid was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | umol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 | Norditropin/Somapacitan |
|
| Secondary | Change in Estimated Glomerular Filtration Rate (GFR) Creatinine (CKD-EPI) (Week 34) | Change in Estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mL/min/1.73m^2 | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Estimated GFR Creatinine (CKD-EPI) (Week 87) | Change in estimated GFR creatinine (CKD-EPI) was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mL/min/1.73m^2 | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Fasting Plasma Glucose (Week 34) | Change in Fasting plasma glucosewas measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Fasting Plasma Glucose (Week 87) | Change in Fasting plasma glucose was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Fasting Insulin (Week 34) | Change in Fasting insulin was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | pmol/L | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Fasting Insulin (Week 87) | Change in Fasting insulin was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | pmol/L | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Steady State Beta Cell Function (%B) (Week 34) | Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Percentage of beta cell function | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
| |
| Secondary | Change in Steady State Beta Cell Function (%B) (Week 87) | Change in steady state beta cell function (%B) was measured from baseline (week -3) until the end of the week 87. | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Percentage of beta cell function | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
|
| Secondary | Change in Insulin Resistance (IR %) (Week 34) | Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Percentage of insulin resistance | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
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| Secondary | Change in Insulin Resistance (IR %) (Week 87) | Change in Insulin resistance (IR %) was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Percentage of insulin resistance | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
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| Secondary | Change in Glycated Haemoglobin (HbA1c) (%) (Week 34) | Change in Glycated haemoglobin (HbA1c) (%) was measured from baseline (week -3) until the end of the main treatment period (week 34). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Percentage of HbA1c | | Week -3, week 34 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Participants received placebo matched to somapacitan for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG001 | Norditropin | Participants recieved Norditropin® FlexPro® 10 mg/1.5 mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. | | OG002 | Somapacitan | Participants received Somapacitan PDS290 10mg/1.5mL for 34 weeks (8 weeks dose titration followed by 26 weeks fixed dose treatment) in the main phase of the trial. |
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| Secondary | Change in Glycated Haemoglobin (HbA1c) (%) (Week 87) | Change in Glycated haemoglobin (HbA1c) was measured from baseline (week -3) until the end of the extension treatment period (week 87). | Overall number of participants analyzed = number of participants with available data. | Posted | | Mean | Standard Deviation | Percentage of HbA1c | | week -3, week 87 | | | | ID | Title | Description |
|---|
| OG000 | Placebo/Somapacitan | Participants who received placebo in the main period, were switched to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG001 | Somapacitan/Somapacitan | Participants who received somapacitan in the main period, continued to receive somapacitan for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG002 | Norditropin/Norditropin | Participants who received Norditropin in the main period, continued to receive Norditropin for 52 weeks (8 weeks dose titration followed by 44 weeks fixed dose treatment) in the extension period of the trial. | | OG003 |
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