March 18, 2018
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Semaglutide produces weight loss in adults with obesity, without diabetes

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Patrick O'Neil
Patrick M. O'Neil

CHICAGO — Nearly two-thirds of adults with obesity and without diabetes who received daily injections of the GLP-1 receptor agonist semaglutide decreased their body weight by at least 10% compared with about one-third of those taking liraglutide, according to results of a phase 2 study presented here.

Semaglutide (Ozempic, Novo Nordisk) is currently approved for treating type 2 diabetes; the GLP-1 receptor agonist liraglutide is approved for treating both type 2 diabetes (Victoza, Novo Nordisk) and obesity (Saxenda, Novo Nordisk).

“All doses of semaglutide were associated with significantly greater weight loss than was seen with placebo,” Patrick M. O’Neil, PhD, professor of psychiatry and behavioral sciences and director of the Weight Management Center at the Medical University of South Carolina, told Endocrine Today. “The highest-dose group had weight loss greater than what is typically seen with pharmaceutical plus lifestyle change treatment (13.8%).”

O’Neil and colleagues conducted a randomized, double-blind, dose-ranging trial comparing semaglutide with liraglutide and placebo. The 957 participants (35% men; mean age; 47 years; mean BMI, 39 kg/m2) did not have diabetes, and had made at least previous attempt to lose weight. Participants were randomly assigned in a 6:1 ratio to receive a GLP-1 receptor agonist or placebo, with 102 or 103 participants in each drug group. Semaglutide in doses of 0.05 mg, 0.1 mg, 0.2 mg, 0.3 mg or 0.4 mg and liraglutide 3 mg were delivered in once-daily injections after escalation to reach the target dose. Placebo groups for each drug group received a matched-volume daily placebo injection. All participants received counseling on diet and physical activity.

At the end of 52 weeks, estimated mean weight loss for the placebo groups was –2.3%. The liraglutide group had an estimated mean weight loss of –7.8% compared with –6% for the semaglutide 0.05-mg group, –8.6% for the 0.1-mg group, –11.6% for the 0.2-mg group, –11.2% for the 0.3-mg group and –13.8% for the 0.4-mg group (P = .001 vs. placebo for .05 mg; P < .0001 all others vs. placebo; P < .01 for 0.2-.04 mg vs. liraglutide).

In all but the lowest-dose semaglutide group, more participants achieved at least 5% weight loss vs. placebo (23%) and liraglutide (66%), with 83% of those in the 0.4-mg semaglutide group achieving that endpoint (P < .0001 vs placebo for all). Similar results were seen for those achieving at least 10% weight loss: 10% of the placebo group, 34% of the liraglutide group and 19% with semaglutide 0.05 mg (not significant vs. placebo), 37% with 0.1 mg, 56% with 0.2 mg, 58% with 0.3 mg and 65% with 0.4 mg (P <.0001 vs placebo for all semaglutide doses).

Semaglutide was generally well-tolerated with some mild gastrointestinal effects seen with increasing doses common to GLP-1 receptor agonists, according to O’Neil.

“[The] biggest surprise [for the audience] may be the amount of weight loss in the highest dosing groups,” O’Neil said. “Phase 3 studies will be important to replicate these findings.” –Jill Rollet

Reference:

O’Neil PM, et al. OR12-5. Presented at: The Endocrine Society Annual Meeting; March 17-20, 2018; Chicago.

Disclosures: This study was supported by Novo Nordisk A/S. O’Neil reports he is a research investigator, advisory board member and grant recipient for Novo Nordisk, and has received honoraria from Janssen, Vindico CME and WebMD.