SILVER SPRING, Md. - Researchers have found in a new study that treatment with Bimagrumab is safe and effective for treating excess adiposity and metabolic disturbances of adult patients with obesity and type 2 diabetes.
Bimagrumab is an antibody that blocks activin type II receptors and stimulates skeletal muscle growth.
The research has been published in JAMA Network Open.
Obesity is the new global epidemic often accompanied by insulin resistance, chronic inflammation, and related comorbid diseases.
The researchers conducted the study to evaluate the efficacy and safety of bimagrumab on body composition and glycemic control in adults with type 2 diabetes and overweight and obesity.
"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.
The researchers concluded that in this phase 2 randomized clinical trial, ActRII blockade with bimagrumab led to significant loss of Fat Mass, gain in Lean Mass, and metabolic improvements during 48 weeks in patients with overweight or obesity who had type 2 diabetes. ActRII pathway inhibition may provide a novel approach for the pharmacologic management of excess adiposity and accompanying metabolic disturbances.
Partial results of this study were presented during a research forum titled "Emerging Pharmacological Anti-obesity Therapies" at ObesityWeek® 2019 in Las Vegas, Nevada.
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.
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JAMA Netw Open. 2021;4(1):e2033457. doi:10.1001/jamanetworkopen.2020.33457