A phase 2 clinical trial demonstrated the effectiveness of Bimagrumab in reducing body fat by nearly 21% and increasing lean mass by 3.6%, resulting in a significant 6.5% body weight reduction among obese patients with type 2 diabetes.
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.
Significant Reductions in Body Fat and Increases in Lean Mass
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, Nevada.
Reference: “Effect of Bimagrumab vs Placebo on Body Fat Mass Among Adults With Type 2 Diabetes and Obesity: A Phase 2 Randomized Clinical Trial” by Steven B. Heymsfield, MD; Laura A. Coleman, PhD, RD; Ram Miller, MD; Daniel S. Rooks, PhD; Didier Laurent, PhD; Olivier Petricoul, PhD; Jens Praestgaard, PhD; Therese Swan, PharmD; Thomas Wade, MD; Robert G. Perry, MD; Bret H. Goodpaster, PhD and Ronenn Roubenoff, MD, MHS, 13 January 2021, JAMA Network Open.
DOI: 10.1001/jamanetworkopen.2020.33457
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.
[Editor’s Note: The caption was added to the image after publication.]
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15 Comments
How much dextrose was given to the placebo group? If the study was focusing on diabetic and obese patients, wouldn’t it make sense to use N-saline instead of dextrose? I mean, the effect might be small, but a good study design shouldn’t allow for even minor quibbles.
@TheHeck – reading the actual study, both injections had the same amount of dextrose in them (5%). The study is at the JAMA Network dot com website.
That picture looks fake. The arm actually gets longer.
There were no released photos associated with the article. The image is a stock photo meant to illustrate the concept of weight loss. Since this wasn’t obvious to everyone, a caption has been added to the image.
Why did you use a photoshopped image of a woman who was not obese? That does not reflect the article, and the model was unlikely to be involved in the study.
Ozempic and Trulicity already exist that help people lose weight but no one can afford to pay cash for these just to lose weight. Both are diabetes injections once a week. 2 pills Jardiance and Farxiga can also help weight loss but are also unaffordable to cash payers. Farxiga is $28 for 30 pills in Brazil $900 here in US. Explain that!
What was effect on A1c levels? Did patients feel any different or experience side effects? If so what were they? Is this trial recorded for it to be read in its entirety?
Need an apetite blocker without side effects. Happens in the brain. Liver enzymes in the blood causes anorexia.
I am so sick and tired of hearing weight loss benefits for IDIOTIC self-causing type 2 diabetics. Drives me NUTS!!! Almost as bad are these people who show great results with keto diets. Anyone knows what happens to ACTUAL diabetics who deal with ketoacidosis?! PAIN!! Absolute and relentless pain until dosed up with enough stabilizers to put more of the body into worse conditions, and YET people willing to do so cause they can, vs. people to absentminded to take care of themselves and create some made up secondary disease to make obese people feel accepted in the medical community rather than DO something about it.
Yes this is all harsh. Yes I’ve been through it, and YES, if it wasn’t the case, I clearly wouldn’t have to say anything about it.
Type 2 diabetics are the equivalent of someone with a severe asthma and breathing lung condition and STILL decides to smoke with an oxygen tank strapped to their faces.
Smite me for my words if you want, though I ask you all this: If you had the choice to better yourself, because it keeps you alive and around for your family, would you NOT take that to BE better instead of selfishly destroying your life and taking the benefits of those who ACTUALLY need it?!
So many idiots in these comments that don’t understand the normal use of stock photos… -_-
If you think the picture above is directly related to the study, you need to get off the internet NOW before you legitimately hurt yourself.
Need diet groups to includ÷ over weight people ×with stimas and ileostomy’s! We are part of the population too!
What is wrong with this pic…the person is not obese and is female. Time to fat shame males.
1/2 plate meat and 1/2 plate vegetables…the end.
Another SCAM by the Democrats.
You might say, “But the placebo effect only works if people are conned into believing that they’re getting the actual drug!” Yet, it works even if patients are told in advance about the drugs being fake! In other words, belief in the placebo effect itself might be enough to encourage our bodies to heal. Yes, placebo effects are limited to patients’ subjective symptoms, especially depression and pain. One effect is not equal for all conditions. Nor do all patients respond equally. More info you will find here – net-bossorg/the-power-of-the-placebo-effect-by-randy-baker