drugset / Trial / NCT02453711
Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus
RandomizedParallel-groupDouble-blindTreatment
Summary
This trial is conducted globally. The aim of this trial is to investigate safety and efficacy of once-daily semaglutide in obese subjects without diabetes mellitus.
Timeline
- Start
- 2015-10-01
- Primary completion
- 2017-03-30
- Completion
- 2017-04-12
Publications
- Background Kolotkin RL, Williams VSL, Ervin CM, Williams N, Meincke HH, Qin S, von Huth Smith L, Fehnel SE. Validation of a new measure of quality of life in obesity trials: Impact of Weight on Quality of Life-Lite Clinical Trials Version. Clin Obes. 2019 Jun;9(3):e12310. doi: 10.1111/cob.12310. Epub 2019 Apr 16.
- Results O'Neil PM, Birkenfeld AL, McGowan B, Mosenzon O, Pedersen SD, Wharton S, Carson CG, Jepsen CH, Kabisch M, Wilding JPH. Efficacy and safety of semaglutide compared with liraglutide and placebo for weight loss in patients with obesity: a randomised, double-blind, placebo and active controlled, dose-ranging, phase 2 trial. Lancet. 2018 Aug 25;392(10148):637-649. doi: 10.1016/S0140-6736(18)31773-2. Epub 2018 Aug 16.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Liraglutide | Peptide | 3 mg | Subcutaneous |
| Subject | Semaglutide | Peptide | 0.05 mg | Subcutaneous |
| Subject | Semaglutide | Peptide | 0.1 mg | Subcutaneous |
| Subject | Semaglutide | Peptide | 0.2 mg | Subcutaneous |
| Subject | Semaglutide | Peptide | 0.3 mg | Subcutaneous |
| Subject | Semaglutide | Peptide | 0.4 mg | Subcutaneous |