Obesity or overweight Diabetes Mellitus, Type 2
Conditions
Brief summary
Percent change from baseline in body weight at 68 weeks of treatment
Detailed description
Absolute change in weight from baseline at 68 weeks of treatment, Achievement of at least 5% body weight loss from baseline at 68 weeks of treatment, Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment, Percent change from baseline in body weight at 68 weeks of treatment, Change in haemoglobin A1C from baseline at 68 weeks of treatment, Change in waist circumference from baseline at 68 weeks of treatment, Percent change in triglycerides from baseline at 68 weeks of treatment, Change in systolic blood pressure from baseline at 68 weeks of treatment, Changes in PRO score from baseline at 68 weeks of treatment, Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA, Occurrence and time to first occurrence of AE, SAE, SAE with outcome death, AE leading to discontinuation of investigational intervention, AE leading to interruption of investigational intervention, other action taken related to investigational intervention, possibly related AE as assessed by investigator, possibly related SAE as assessed by investigator, Observed laboratory values change from baseline and time to first treatment emergent abnormality, Observed vital sign value (including systolic and diastolic blood pressure, pulse rate), change from baseline, and time to first treatment emergent abnormality, Observed ECG parameter, change from baseline, and time to first treatment emergent abnormality, Observed changes in DXA body composition from baseline, in a subset of participants
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change from baseline in body weight at 68 weeks of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Absolute change in weight from baseline at 68 weeks of treatment, Achievement of at least 5% body weight loss from baseline at 68 weeks of treatment, Achievement of at least 10% body weight loss from baseline at 68 weeks of treatment, Percent change from baseline in body weight at 68 weeks of treatment, Change in haemoglobin A1C from baseline at 68 weeks of treatment, Change in waist circumference from baseline at 68 weeks of treatment, Percent change in triglycerides from baseline at 68 weeks of treatment, Change in systolic blood pressure from baseline at 68 weeks of treatment, Changes in PRO score from baseline at 68 weeks of treatment, Percent change in fat mass from baseline at 68 weeks of treatment measured by DXA, Occurrence and time to first occurrence of AE, SAE, SAE with outcome death, AE leading to discontinuation of investigational intervention, AE leading to interruption of investigational intervention, other action taken related to investigational intervention, possibly r | — |