| Primary | Semaglutide 7.2 mg Versus Placebo: Relative Change in Body Weight | Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Mean | Standard Deviation | Percentage (%) change in body weight | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-19.5± 10.6
- OG001-3.8± 7.1
|
|
| | 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 |
|---|
| | ANCOVA | | <0.0001 | | Treatment difference | -14.81 | | | 2-Sided | 95 | -16.21 | -13.41 | | | | | Superiority | | |
|
| Primary | Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction Greater Than or Equal to (>=) 5% (Yes/no) | Number of participants who achieve body weight reduction >=5% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=5% and "no" defines participants who did not achieve body weight reduction >=5%. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Count of Participants | | Participants | | At week 72 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=10% (Yes/no) | Number of participants who achieve body weight reduction >=10% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=10% and "no" defines participants who did not achieve body weight reduction >=10%. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Count of Participants | | Participants | | At week 72 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=15% (Yes/no) | Number of participants who achieve body weight reduction >=15% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=15% and "no" defines participants who did not achieve body weight reduction >=15%. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Count of Participants | | Participants | | At week 72 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no) | Number of participants who achieve body weight reduction >=20% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=20% and "no" defines participants who did not achieve body weight reduction >=20%. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Count of Participants | | Participants | | At week 72 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Placebo: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no) | Number of participants who achieve body weight reduction >=25% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=25% and "no" defines participants who did not achieve body weight reduction >=25%. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Count of Participants | | Participants | | At week 72 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Waist Circumference | Change in waist circumference from baseline (week 0) to end of treatment (week 72) is presented. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Mean | Standard Deviation | Centimeter (cm) | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Relative Change in Body Weight | Relative change in body weight from baseline (week 0) to end of treatment (week 72) is presented. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups. | Posted | | Mean | Standard Deviation | Percentage (%) change in body weight | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Semaglutide 2.4 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=20% (Yes/no) | Number of participants who achieve body weight reduction >=20% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=20% and "no" defines participants who did not achieve body weight reduction >=20%. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups. | Posted | | Count of Participants | | Participants | | At week 72 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Semaglutide 2.4 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of Participants Who Achieve Body Weight Reduction >=25% (Yes/no) | Number of participants who achieve body weight reduction >=25% from baseline (week 0) is presented in categories as "yes" or "no" where "yes" defines participants who achieved body weight reduction >=25% and "no" defines participants who did not achieve body weight reduction >=25%. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups. | Posted | | Count of Participants | | Participants | | At week 72 | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Semaglutide 2.4 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Body Weight | Change in body weight from baseline (week 0) to end of treatment (week 72) is presented. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Mean | Standard Deviation | Kilograms (kg) | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Body Mass Index (BMI) | Change in BMI from baseline (week 0) to end of treatment (week 72) is presented. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Mean | Standard Deviation | kilogram per square meter (kg/m^2) | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Change in Body Weight | Change in body weight from baseline (week 0) to end of treatment (week 72) is presented. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups. | Posted | | Mean | Standard Deviation | Kg | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Semaglutide 2.4 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72. |
| |
| Secondary | Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (%) | Change in total fat volume (%) from baseline (week 0) to end of treatment (week 72) is presented. | MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in Statistical Analysis Plan(SAP) section 4.3.2, the reporting groups semaglutide 7.2 and semaglutide 2.4 mg were planned to be pooled for analysis of the outcome measure. Hence, data is represented in singled pooled semaglutide (7.2mg + 2.4mg) arm. | Posted | | Mean | Standard Deviation | % of total fat volume | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Pooled Semaglutide (7.2 mg + 2.4 mg) | Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Pooled Semaglutide Versus Placebo: Change in Total Fat Volume (Liters) | Change in total fat volume (liters) from baseline (week 0) to end of treatment (week 72) is presented. | MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm. | Posted | | Mean | Standard Deviation | liters | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Pooled Semaglutide (7.2 mg + 2.4 mg) | Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (%) | Change in lean body volume (%) from baseline (week 0) to end of treatment (week 72) is presented. | MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm. | Posted | | Mean | Standard Deviation | % of lean body volume | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Pooled Semaglutide (7.2 mg + 2.4 mg) | Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Pooled Semaglutide Versus Placebo: Change in Lean Body Volume (Liters) | Change in lean body volume (liters) from baseline (week 0) to end of treatment (week 72) is presented. | MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm. | Posted | | Mean | Standard Deviation | liters | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Pooled Semaglutide (7.2 mg + 2.4 mg) | Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (%) | Change in visceral fat volume (%) from baseline (week 0) to end of treatment (week 72) is presented. | MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm. | Posted | | Mean | Standard Deviation | % of visceral fat volume | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Pooled Semaglutide (7.2 mg + 2.4 mg) | Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Pooled Semaglutide Versus Placebo: Change in Visceral Fat Volume (Liters) | Change in visceral fat volume (liters) from baseline (week 0) to end of treatment (week 72) is presented. | MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm. | Posted | | Mean | Standard Deviation | liters | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Pooled Semaglutide (7.2 mg + 2.4 mg) | Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Pooled Semaglutide Versus Placebo: Change in Body Weight (%) | Change in body weight (%) from baseline (week 0) to end of treatment (week 72) is presented. | MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm. | Posted | | Mean | Standard Deviation | % of body weight | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Pooled Semaglutide (7.2 mg + 2.4 mg) | Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Pooled Semaglutide Versus Placebo: Change in Body Weight (Kg) | Change in body weight (Kg) from baseline (week 0) to end of treatment (week 72) is presented. | MRI analysis set included all participants in the sub-population of Full analysis set that have had a valid MRI scan performed at baseline. Overall number of participants analyzed = Participants with available data for the outcome measure. As defined in SAP section 4.3.2, the reporting groups semaglutide 7.2 mg and semaglutide 2.4 mg were planned to be pooled for analysis of the out-come measure. Hence, data is represented in singled pooled semaglutide (7.2 mg + 2.4 mg) arm. | Posted | | Mean | Standard Deviation | Kg | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Pooled Semaglutide (7.2 mg + 2.4 mg) | Participants received semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of either 7.2 mg or 2.4 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Systolic Blood Pressure | Change in systolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Mean | Standard Deviation | millimeters of mercury (mmHg) | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Diastolic Blood Pressure | Change in diastolic blood pressure from baseline (week 0) to end of treatment (week 72) is presented. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Mean | Standard Deviation | mmHg | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Milligram Per Deciliter [mg/dL]) - Ratio to Baseline | Change in total cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of total cholesterol | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
| |
| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Total Cholesterol (Millimoles Per Liter [mmol/L]) - Ratio to Baseline | Change in total cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of total cholesterol | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
|---|
| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in High-density Lipoprotein (HDL) Cholesterol (mg/dL) - Ratio to Baseline | Change in HDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of HDL cholesterol | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: 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 72) is presented as ratio to baseline (week 0). | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of HDL cholesterol | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: 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 72) is presented as ratio to baseline (week 0). | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of LDL cholesterol | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: 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 72) is presented as ratio to baseline (week 0). | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of LDL cholesterol | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mg/dL) - Ratio to Baseline | Change in VLDL cholesterol in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of VLDL cholesterol | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Very Low-density Lipoprotein (VLDL) Cholesterol (mmol/L) - Ratio to Baseline | Change in VLDL cholesterol in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of VLDL cholesterol | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mg/dL) - Ratio to Baseline | Change in triglycerides in mg/dL from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of triglycerides | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Triglycerides (mmol/L) - Ratio to Baseline | Change in triglycerides in mmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of triglycerides | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in High-sensitivity C-reactive Protein (hsCRP) - Ratio to Baseline | Change in hsCRP (milligram per liter [mg/L]) from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of hsCRP | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Lipid-lowering Treatment (Decrease, no Change, Increase) | Number of participants with change in lipid-lowering treatment from baseline (week 0) is presented in categories as decrease, no change and increase. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Count of Participants | | Participants | | At week 72 | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Antihypertensive Treatment (Decrease, no Change, Increase) | Number of participants with change in antihypertensive treatment from baseline (week 0) is presented in categories as decrease, no change and increase. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Count of Participants | | Participants | | At week 72 | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Glycated Haemoglobin (HbA1c) | Change in HbA1c from baseline (week 0) to end of treatment (week 72) is presented. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Mean | Standard Deviation | % of HbA1c | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Fasting Plasma Glucose | Change in fasting plasma glucose from baseline (week 0) to end of treatment (week 72) is presented. | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Mean | Standard Deviation | mg/dL | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Picomoles Per Liter [Pmol/L]) - Ratio to Baseline | Change in fasting serum insulin in pmol/L from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting serum insulin | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Fasting Serum Insulin (Milliinternational Units Per Milliliter [mIU/mL]) - Ratio to Baseline | Change in fasting serum insulin in mIU/ml from baseline (week 0) to end of treatment (week 72) is presented as ratio to baseline (week 0). | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of fasting serum insulin | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Number of Participants With Change in Glycaemic Category (Normo-glycaemia, Pre-diabetes) | Number of participants with change in glycaemic category from baseline (week 0) to the end of treatment (week 72) is presented. These categories were set as per the following criteria: 1) Normo-glycaemia: glycated haemoglobin (HbA1c) <5.7%; 2) Pre-diabetes: 5.7% <= HbA1c < 6.5% | Full analysis set included all randomized participants. Participants were analysed according to the randomised treatment. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Count of Participants | | Participants | | Baseline (week 0), end of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Number of Adverse Events (AEs) | Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. | Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Number | | Events | | From baseline (week 0) to end of study (week 81) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Number of Serious Adverse Events (SAEs) | Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event. | Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Number | | Events | | From baseline (week 0) to end of study (week 81) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Placebo: Change in Pulse | Change in pulse from baseline (week 0) to end of treatment (week 72) is presented. | Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. Overall number of participants analyzed = Participants with available data for the outcome measure. The outcome measure was planned to be assessed for semaglutide 7.2 mg and placebo groups. | Posted | | Mean | Standard Deviation | Beats per minute (bpm) | | Baseline (week 0), End of treatment (week 72) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Placebo | Participants received placebo (matched to Semaglutide) subcutaneously once weekly for up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of AEs | Number of AEs is reported. An AE is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of IMP, whether or not considered related to the IMP. | Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups. | Posted | | Number | | Events | | From baseline (week 0) to end of study (week 81) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Semaglutide 2.4 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72. |
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| Secondary | Semaglutide 7.2 mg Versus Semaglutide 2.4 mg: Number of SAEs | Number of SAEs is reported. A SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect or important medical event. | Safety analysis set included all participants who were exposed to at least one dose of randomised trial product. Participants were analysed according to the treatment they actually received. The outcome measure was planned to be assessed for semaglutide 7.2 mg and semaglutide 2.4 mg groups. | Posted | | Number | | Events | | From baseline (week 0) to end of study (week 81) | | | | ID | Title | Description |
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| OG000 | Semaglutide 7.2 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 7.2 mg once weekly up to week 72. | | OG001 | Semaglutide 2.4 mg | Participants received Semaglutide subcutaneously once weekly in a fixed-dose escalation manner, with dose increases every 4 weeks for up to week 20 (0.25 mg, 0.5 mg, 1.0 mg, 1.7 mg, 2.4 mg) followed by maintenance dose of 2.4 mg once weekly up to week 72. |
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