Investigation of Safety and Efficacy of Once-daily Semaglutide in Obese Subjects Without Diabetes Mellitus

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

Outcome

Met primary endpoint

registry analysis (other test); Semaglutide 0.05 mg vs Placebo Pool; p =0.0055; Treatment difference (%-points) -3.70 (95% CI -6.55 to -0.85); ANCOVA NCT02453711 ↗

paper All semaglutide groups versus placebo were significant (unadjusted p≤0·0010), and remained significant after adjustment for multiple testing (p≤0·0055). PMID 30122305 ↗

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

Indications