| Primary | Change in Body Weight (%) : In-trial Observation Period | Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | Percentage of body weight | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-16.4± 7.3
- OG001-2.6± 5.8
|
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| | 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 |
|---|
| Treatment policy Estimand. The primary endpoint was analysed using an analysis of covariance (ANCOVA) model with randomized treatment as factor and baseline body weight as covariate. Analysed data is from in-trial observation period. | ANCOVA | | <0.0001 | | Treatment difference | -12.99 | | | 2-Sided | 95 | -15.28 | -10.70 | | | | | Superiority | | |
|
| Primary | Change in Body Weight (%) : On-treatment Observation Period | Change in percentage (%) of body weight from baseline (week 0) to end of treatment (week 44) is presented in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: The time period where participants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses. | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | Percentage of body weight | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Primary | Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : In-trial Observation Period | Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this outcome measure and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial observation period: The time period where the participants were assessed in the study. The in-trial observation period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Count of Participants | | Participants | | At week 44 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | |
|
| Primary | Number of Participants Achieved More Than or Equal to (≥) 5 Percent (%) Body Weight Reduction (Yes/no) : On-treatment Observation Period | Number of participants who achieved body weight reduction more than or equal to 5 percent is presented at week 44 in this endpoint. The endpoint was evaluated based on the data from on-treatment observation period. On-treatment observation period: the time period where partici-pants were treated with trial product. It started from the date of first trial product administration (week 0) to the date of last trial product administration (week 44) including 2 weeks of follow up. It excludes off treatment period which is defined as at least 2 consecutive missed doses. | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Count of Participants | | Participants | | At week 44 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | |
|
| Secondary | Number of Participants Achieved ≥ 10% Body Weight Reduction (Yes/no) | Number of participants who achieved body weight reduction more than or equal to 10 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Count of Participants | | Participants | | At week 44 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Secondary | Number of Participants Achieved ≥15% Body Weight Reduction (Yes/no) | Number of participants who achieved body weight reduction more than or equal to 15 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Count of Participants | | Participants | | At week 44 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
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| Secondary | Number of Participants Achieved ≥20% Body Weight Reduction (Yes/no) | Number of participants who achieved body weight reduction more than or equal to 20 percent is presented at week 44 and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Count of Participants | | Participants | | At week 44 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Secondary | Change in Waist Circumference | Change in waist circumference from baseline (week 0) to the end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | Centimeter (cm) | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Secondary | Change in Body Weight (kg) | Change in body weight in kilogram (kg) is presented from baseline (week 0) to the end of treatment (week 44) and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | Kg | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Secondary | Change in Body Mass Index | Change in body mass index from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | Kilogram per square meter (kg/m^2) | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Secondary | Change in Systolic Blood Pressure (mmHg) | Change in systolic blood pressure from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | Millimeter of mercury (mmHg) | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Secondary | Change in Diastolic Blood Pressure | Change in diastolic blood pressure from baseline (week 0) to end of the treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | MmHg | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Secondary | Change in Total Cholesterol (mg/dL) - Ratio to Baseline | Change in total cholesterol in milligram per deciliter (mg/dL) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of total cholesterol | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | |
|
| Secondary | Change in Total Cholesterol (mmol/L) - Ratio to Baseline | Change in total cholesterol in millimoles per liter (mmol/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of total cholesterol | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | |
|
| Secondary | Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline | Change in HDL cholesterol in mg/dL from (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of HDL cholesterol | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Secondary | Change in High-density Lipoprotein (HDL) Cholesterol (mmol/L) - Ratio to Baseline | Change in HDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of HDL cholesterol | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | |
|
| Secondary | Change in Low-density Lipoprotein (LDL) Cholesterol (mg/dL) - Ratio to Baseline | Change in LDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of LDL cholesterol | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
|
| Secondary | Change in Low-density Lipoprotein (LDL) Cholesterol (mmol/L) - Ratio to Baseline | Change in LDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of LDL cholesterol | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
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| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
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| Secondary | Change in Triglycerides (mg/dL) - Ratio to Baseline | Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of triglycerides | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
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| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
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| Secondary | Change in Triglycerides (mmol/L) - Ratio to Baseline | Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of triglycerides | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
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| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
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| Secondary | Change in High-sensitivity C-reactive Protein (hsCRP) (mg/L) - Ratio to Baseline | Change in hsCRP in milligram per liter (mg/L) from baseline (week 0) to end of treatment (week 44) as ratio to baseline is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of hsCRP | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
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| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
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| Secondary | Change in HbA1c (%) | Change in glycosylated haemoglobin (HbA1c) in percentage from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | Percentage of HbA1c | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
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| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
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| Secondary | Change in HbA1c (mmol/Mol) | Change in glycosylated heamoglobin (HbA1c) in millimoles per mole (mmol/mol) from baseline (week 0) to end of treatment (week 44) is presented and it was evaluated based on the data from in-trial observation period. For end of treatment visit, data collected up to week 49 during the in-trial observation period is included in this Outcome Measure. In-trial period: The time period where the participants were assessed in the study. The in-trial period begins on the date of randomization (week 0) and ends at the end of study visit (week 49). | FAS included all randomized participants. Here, Overall number of participants analysed (N) = participants with available data for this outcome measure. | Posted | | Mean | Standard Deviation | Mmol/mol | | Baseline (week 0), end of treatment (week 44) | | | | ID | Title | Description |
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| OG000 | Semaglutide | Participants received 2.4 mg semaglutide subcutaneous injection once weekly using PDS290 pen injector for 44 weeks. Participants initially received (0.25 mg) semaglutide once weekly and the dose was then escalated once in 4 weeks until the maintenance dose (2.4 mg) was reached: 0.25 mg (week 1 - week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. | | OG001 | Placebo | Participants received placebo matched to semaglutide once weekly by subcutaneous injection for 44 weeks. Participants initially received 0.25 mg placebo matched to semaglutide once weekly and the dose was then escalated once in 4 weeks until maintenance dose was reached: 0.25 mg (week 1- week 4), 0.5 mg (week 5 - week 8), 1.0 mg (week 9 - week 12), 1.7 mg (week 13 - week 16), 2.4 mg (week 17 - week 44). The treatment was an adjunct to a reduced-calorie diet and increased physical activity. |
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