parallel randomized trial
NCT03600480
Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Combination With Semaglutide in Subjects Being Overweight or With Obesity
Design
Conduct and analysis
Arms
| Arm | Treatment | Background | Randomized | Analyzed | Completed treatment |
|---|---|---|---|---|---|
| A1 | semaglutide and cagrilintide AM833 0.16 mg plus semaglutide 2.4 mg | lifestyle: not reported | |||
| A2 | semaglutide and cagrilintide AM833 0.3 mg plus semaglutide 2.4 mg | lifestyle: not reported | |||
| A3 | semaglutide and cagrilintide AM833 0.6 mg plus semaglutide 2.4 mg | lifestyle: not reported | |||
| A4 | semaglutide and cagrilintide AM833 1.2 mg plus semaglutide 2.4 mg | lifestyle: not reported | |||
| A5 | Cagrilintide and semaglutide 2.4/2.4 mg subcutaneous once weekly AM833 2.4 mg plus semaglutide 2.4 mg | lifestyle: not reported | |||
| A6 | semaglutide and cagrilintide AM833 4.5 mg plus semaglutide 2.4 mg | lifestyle: not reported | |||
| A7 | Semaglutide 2.4 mg subcutaneous once weekly Pooled placebo plus semaglutide 2.4 mg | lifestyle: not reported | |||
| A8 | Semaglutide 2.4 mg subcutaneous once weekly Matched placebo plus semaglutide 2.4 mg | lifestyle: not reported |
Baseline characteristics
As printed in the trial reports or registry, per arm or for the whole trial.
| Characteristic | Statistic | AM833 0.16 mg plus semaglutide 2.4 mg A1 | AM833 0.3 mg plus semaglutide 2.4 mg A2 | AM833 0.6 mg plus semaglutide 2.4 mg A3 | AM833 1.2 mg plus semaglutide 2.4 mg A4 | Cagrilintide and semaglutide 2.4/2.4 mg subcutaneous once weekly A5 | AM833 4.5 mg plus semaglutide 2.4 mg A6 | Semaglutide 2.4 mg subcutaneous once weekly A7 | Semaglutide 2.4 mg subcutaneous once weekly A8 | Whole trial ALL |
|---|---|---|---|---|---|---|---|---|---|---|
| age | mean (years) | 40.6 | ||||||||
| bmi | mean (kg/m2) | 32.1 | ||||||||
| other male | percent | 59 | ||||||||
| weight | mean (kg) | 95.7 |
Results
5 adjudicated result lines, grouped by outcome. Open an outcome to see its values.
Percent body weight change (5 lines; O10)
| Week | Arm | Statistic | Estimate | SE or SD | 95% CI | Events / N | Detail |
|---|---|---|---|---|---|---|---|
| 20 | A4 | percent change | -15.7 percent | not stated; other; R0012827:Abstract | |||
| 20 | A5 | percent change | -17.1 percent | not stated; other; R0012827:Abstract | |||
| 20 | A6 | percent change | -15.4 percent | not stated; other; R0012827:Abstract | |||
| 20 | A7 | percent change | -9.8 percent | not stated; other; R0012827:Abstract | |||
| 20 | A8 | percent change | -8.0 percent | not stated; other; R0012827:Abstract |