SILVER SPRING, Md.–A new study confirms that treatment with Bimagrumab, an antibody that blocks activin type II receptors and stimulates skeletal muscle growth, is safe and effective for treating excess adiposity and metabolic disturbances of adult patients with obesity and type 2 diabetes.
“These exciting results suggest that there may be a novel mechanism for achieving weight loss with a profound loss of body fat and an increase in lean mass, along with other metabolic benefits,” said Steve Heymsfield, MD, FTOS, past president of The Obesity Society and corresponding author of the study. Heymsfield is professor and director of the Metabolism and Body Composition Laboratory at the Pennington Biomedical Research Center in Baton Rouge, La.
A total of 75 patients with type 2 diabetes, body mass index between 28 and 40 and glycated hemoglobin A1c levels between 6.5 percent and 10 percent were selected for the phase 2 randomized clinical trial. Patients were injected with either Bimagrumab or a placebo (a dextrose solution) every 4 weeks for 48 weeks. Both groups received diet and exercise counseling. The research took place at nine sites in the United States and the United Kingdom from February 2017 to May 2019.
At the end of the 48-week study, researchers found a nearly 21 percent decrease in body fat in the Bimagrumab group compared to 0.5 percent in the placebo group. The results also revealed the Bimagrumab group gained 3.6 percent of lean mass compared with a loss of 0.8 percent in the placebo group. The combined loss in total body fat and gain in lean mass led to a net 6.5 percent reduction in body weight in patients receiving Bimagrumab compared with 0.8 percent weight loss in their counterparts receiving the placebo.
The sample size of 75 participants was a limitation of the study. There was also a gender imbalance across the groups with more women randomized to Bimagrumab and more men to the placebo.
Partial results of this study were presented during a research forum titled “Emerging Pharmacological Anti-obesity Therapies” at ObesityWeek® 2019 in Las Vegas, Nev.
Other authors of the study include Laura Coleman, Ram Miller, Daniel Rooks, Jens Praestgaard, and Therese Swan, Translational Medicine, Novartis Institutes for Biomedical Research, Cambridge, Mass. Didier Laurent, Olivier Petricoul, and Ronenn Roubenoff, Translational Medicine, Novartis Institutes of Biomedical Research in Basel, Switzerland, along with Thomas Wade of QPS-Miami Research Associates in Miami, Fla; Robert Perry of Panax Clinical Research of Miami; and Bret Goodpaster of Advent Health Research Institute in Orlando, Fla., also co-authored the study.
Heymsfield reported receiving personal fees from Tanita and Medifast outside of the submitted work. Coleman, Miller, Rooks, Roubenoff, Laurent, Praestgaard, Petricoul and Swan reported being employees of Novartis Institutes for Biomedical Research during the conduct of the study. Coleman and Roubenoff reported having a patent for PAT058683-US-PSP pending with Novartis. Rooks and Roubenoff reported being co-authors of a patent for use of Bimagrumab in other indications that is no longer being developed. Goodpaster reported receiving personal fees from Novartis for work performed during the conduct of the study. No other disclosures were reported.
The paper, titled “Effect of Bimagrumab vs Placebo on Body Fat Mass Among Adults with Type 2 Diabetes and Obesity” is scheduled to be published on Jan. 13, 2021, in JAMA Network Open.
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