| Primary | Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide) | Change in HbA1c from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site. The on-treatment without rescue medication period is a subset of the 'on-treatment' observation period and represents the time period where subjects are considered exposed to trial product but have not initiated any rescue medications. | Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Percentage of HbA1c | | Week 0, Week 32 | | | | ID | Title | Description |
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| OG000 | Cagrilintide 2.4 mg + Semaglutide 2.4 mg | Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). | | OG001 | Semaglutide 2.4 mg + Placebo (Cagrilintide) | Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). |
| | | Title | Denominators | Categories |
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| Change from Baseline - in-trial | | | Title | Measurements |
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| - OG000-2.2± 0.9
- OG001-1.9± 1.0
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| | Change from Baseline - on treatment without rescue | | |
| | 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 |
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| The change in HbA1c from baseline was analysed using an ANCOVA (Analysis of Covariance) with randomised treatment and stratification factor as factors and baseline HbA1c as a covariate using retrieved participants multiple imputation of missing data regardless of treatment or stratification. | Mixed Models Analysis | | 0.2284 | | Treatment difference | -0.30 | | | 2-Sided | 95 | -0.79 | 0.19 | | | | | Other | | |
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| Secondary | Change in Glycated Haemoglobin (HbA1c): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide) | Change in HbA1c from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site. | Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Percentage point of HbA1c | | Week 0, Week 32 | | | | ID | Title | Description |
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| OG000 | Cagrilintide 2.4 mg + Semaglutide 2.4 mg | Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). | | OG001 | Cagrilintide 2.4 mg + Placebo (Semaglutide) | Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). |
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| Secondary | Percentage Change in Body Weight: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide) | Percenatge change in body weight from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site. | Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Percentage of body weight | | Week 0, Week 32 | | | | ID | Title | Description |
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| OG000 | Cagrilintide 2.4 mg + Semaglutide 2.4 mg | Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). | | OG001 | Semaglutide 2.4 mg + Placebo (Cagrilintide) | Participants received Semaglutide 2.4 mg and 2.4 mg placebo (cagrilintide) once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). |
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| Secondary | Change in Body Weight (Kilogram): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide) | Change in body weight from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site. | Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Kilogram | | Week 0, Week 32 | | | | ID | Title | Description |
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| OG000 | Cagrilintide 2.4 mg + Semaglutide 2.4 mg | Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). | | OG001 | Semaglutide 2.4 mg + Placebo (Cagrilintide) | Participants received Semaglutide 2.4 mg and 2.4 mg placebo (cagrilintide) once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). |
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| Secondary | Change in Fasting Plasma Glucose (FPG): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Semaglutide 2.4 mg + Placebo (Cagrilintide) | Change in FPG from baseline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site. | Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Millimoles per liter (mmol/L) | | Week 0, Week 32 | | | | ID | Title | Description |
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| OG000 | Cagrilintide 2.4 mg + Semaglutide 2.4 mg | Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). | | OG001 | Semaglutide 2.4 mg + Placebo (Cagrilintide) | Participants received 2.4 mg semaglutide and placebo matched to 2.4 mg cagrilintide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). |
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| Secondary | CGM: Change in Mean Glucose: Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide) | Change in mean glucose from baslline (week 0) to week 32 is presented. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site. | Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Millimoles per liter (mmol/l) | | Week 0, Week 32 | | | | ID | Title | Description |
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| OG000 | Cagrilintide 2.4 mg + Semaglutide 2.4 mg | Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). | | OG001 | Cagrilintide 2.4 mg + Placebo (Semaglutide) | Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). |
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| Secondary | Percentage of Time Above Range (TAR) Greater Than 10.0 mmol/L (Greater Than 180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide) | Percentage of TAR greater than 10.0 mmol/L (greater than 180 mg/dL) at week 32 is presented. The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range greater than 10.0 mmol/L (greater than 180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site. | Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Percentage of time | | At week 32 | | | | ID | Title | Description |
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| OG000 | Cagrilintide 2.4 mg + Semaglutide 2.4 mg | Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). | | OG001 | Cagrilintide 2.4 mg + Placebo (Semaglutide) |
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| Secondary | Percentage of Time in Range (TIR) 3.9-10.0 mmol/L (70-180 mg/dL) Measured Using CGM (Continuous Glucose Monitoring): Cagrilintide 2.4 mg + Semaglutide 2.4 mg Versus Cagrilintide 2.4 mg + Placebo (Semaglutide) | Percentage of TIR 3.9-10.0 mmol/L (70-180 mg/dL) at week 32 is presented. The percentage of time spent in glycaemic target range was calculated as 100 times the number of recorded measurements in glycaemic target range 3.9-10.0 mmol/L (70-180 mg/dL), both inclusive divided by the total number of recorded measurements. The endpoint was evaluated based on the data from in-trial period. The in-trial period is defined as the time interval from date of randomization to date of last contact with trial site. | Full analysis set included all randomised participants. Here, "Overall Number of Participants Analyzed" signifies those participants who were evaluable for this outcome measure. | Posted | | Mean | Standard Deviation | Percentage of time | | At week 32 | | | | ID | Title | Description |
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| OG000 | Cagrilintide 2.4 mg + Semaglutide 2.4 mg | Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). | | OG001 | Cagrilintide 2.4 mg + Placebo (Semaglutide) |
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| Secondary | Number of Treatment Emergent Adverse Events (TEAEs) | An adverse event (AE) is any untoward medical occurrence in a clinical trial participants administered or using a medicinal product, whether or not considered related to the medicinal product or usage. A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period. On treatment observation period starts at the date of first dose of trial product and ends at the first date of any of the following; the date of last dose of trial product +35 days for AEs and hypoglycaemic episodes/+ 14 days for other endpoints; the end-date for the 'in-trial' observation period. | Safety analysis set included all randomised participants and who take at least 1 dose of trial product. | Posted | | Number | | Events | | From baseline (week 0) to week 37 | | | | ID | Title | Description |
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| OG000 | Cagrilintide 2.4 mg + Semaglutide 2.4 mg | Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). | | OG001 | Cagrilintide 2.4 mg + Placebo (Semaglutide) | Participants received 2.4 mg cagrilintide and placebo matched to 2.4 mg semaglutide, once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). |
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| Secondary | Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0mmol/L (54mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3) | Clinically significant hypoglycaemic episodes (level 2) were defined as episodes that were sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Number of clinically significant hypoglycaemic episodes (level 2), confirmed by blood glucose (BG) meter or severe hypoglycaemic episodes (level 3) that occurred from week 0 to week 37 are presented. On treatment observation period starts at the date of first dose of trial product and ends at the first date of any of the following; the date of last dose of trial product +35 days for AEs and hypoglycaemic episodes/+ 14 days for other endpoints; the end-date for the 'in-trial' observation period. | Safety analysis set included all randomised participants and who take at least 1 dose of trial product. | Posted | | Number | | Episodes | | From baseline (week 0) to week 37 | | | | ID | Title | Description |
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| OG000 | Cagrilintide 2.4 mg + Semaglutide 2.4 mg | Participants received 2.4 milligram (mg) cagrilintide and 2.4 mg semaglutide once-weekly s.c. (subcutaneously, under the skin) injections for 32 weeks. Participants initially received 0.25 mg 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 to week 4), 0.5 mg (week 5 to week 8), 1.0 mg (week 9 to week 12), 1.7 mg (week 13 to week 16), 2.4 mg (week 17 to week 32). |
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