The study compared patients taking semaglutide with those taking placebo and liraglutide, which is approved for treatment of obesity.
Semaglutide, Novo Nordisk’s once-weekly injection approved last year for type 2 diabetes (T2D), helped 65% of adults lose at least 10% of their body weight over 52 weeks, according to results of a phase 2 trial presented this weekend at the annual meeting of the Endocrine Society in Chicago, Illinois.
The glucagon-like peptide-1 (GLP-1) receptor agonist is being studied as a possible treatment for obesity. It is not approved by the FDA or other regulatory agencies for this purpose, and none of the patients in this phase 2 study had diabetes, according to the abstract. (Novo Nordisk is also developing an oral form of semaglutide.)
The study compared patients receiving 0.4 mg of semaglutide with others taking placebo or 3 mg of liraglutide, the dose of that GLP-1 receptor agonist sold as Saxenda that FDA approved to treat obesity. Patients treated with semaglutide started on a 0.05 mg dose, with daily doses escalating every 4 weeks until patients reached their target dose. All patients received dietary and exercise counseling. Average body mass index was 39 kg/m2, and average age was 47 years; 35% of the 957 participants were male. Results included:
“In the US alone, more than 90 million adults have obesity. We need to continue to research and develop new therapies to support those living with this chronic disease,” Patrick M. O’Neil, PhD, of the Medical University of South Carolina, lead investigator of the study, said in a statement. “I am encouraged by these results and look forward to seeing data from upcoming phase 3 trials to better understand how semaglutide may play a role in the treatment of obesity.”
Novo Nordisk has put considerable investment into obesity, which is frequently not diagnosed in primary care practices even though physicians deal with its effects when they treat diabetes, cardiovascular disease, and other health problems. In an interview last year with The American Journal of Managed Care®, Novo Nordisk Chief Medical Officer Todd Hobbs, MD, discussed results of the ACTION study, which sampled patients, providers, and employers and found an unmet need to discuss obesity during office visits—but a lack of understanding of how to get there.
“Many patients in the survey clearly indicated that it was still sort of their responsibility and they were hesitating to go to their physician” to discuss obesity, Hobbs said. Physicians, meanwhile, did feel that obesity is a disease, but time pressures and lack of resources prevented conversations about it.
Weight loss of at least 5% has been shown to have significant health benefits; for those with prediabetes—which is common with obesity—that level of weight loss increases the likelihood that the individual can avoid progressing to T2D. Weight loss of this amount can also reduce blood pressure by about 5 points and relieve pressure on knee joints.
Novo Nordisk’s Executive Vice President and Chief Science Officer, Mads Krogsgaard Thomsen, said in the statement that the phase 3 program studying semaglutide as a once-weekly treatment for obesity would continue later this year, along with SELECT, the cardiovascular outcomes trial that will evaluate semaglutide’s effect on major cardiovascular events in patients with obesity. SUSTAIN-6 has already showed cardiovascular benefits in patients with diabetes.
O’Neil PM, Birkenfield AL, McGowan B, et al. A randomized, phase II, placebo-and active-controlled dose-ranging study of semaglutide for treatment of obesity in subjects without diabetes. Presented at the 100th Annual Meeting of The Endocrine Society, Chicago, Illinois; March 18, 2018. Abstract OR12-5.