Same caloric intake, less fat tissue, more muscle, smaller waist
At 48 weeks in the bimagrumab vs. placebo group, there was on average (all P < .001):
- A loss of 20.5% vs. 0.5% (−7.5 vs. −0.2 kg) of total body fat mass.
- A loss of 6.5% vs. 0.8% (−5.9 vs. −0.8 kg) of body weight.
- A gain of 3.6% vs. a loss of 0.8% (1.7 vs. −0.4 kg) of lean mass.
Similarly, the relatively large between-group differences in total body fat mass and body weight at 48 weeks with bimagrumab were accompanied by favorable differences in BMI (−2.19 vs. −0.28 kg/m2; P < .001) and waist circumference (−9.0 vs. 0.5 cm; P < .001), the investigators pointed out.
Moreover, the reduction of abdominal visceral adipose tissue and waist circumference with bimagrumab “was nearly twice that observed in a recently published study of patients with type 2 diabetes treated with an intensive lifestyle program and the glucagon-like peptide 1 (GLP-1) agonist liraglutide,” they noted.
This highlights “the importance of moving away from body weight as a primary efficacy marker of drugs to more metabolically relevant endpoints.”
Also, A1c decreased by 0.76% in the bimagrumab group and increased by 0.04% in the placebo group (P = .005).
Serious adverse events occurred in three patients (8%) in the bimagrumab group (elevated lipase, epigastric pain, pancreatitis, pneumonia) and three patients (8%) in the placebo group (cellulitis, acute coronary syndrome, acute myocardial infarction, worsening gastroparesis, thermal burn).
Adverse events were reported by 31 of 37 patients in the bimagrumab group, most often mild diarrhea (41%) and muscle spasms (41%), and 31 of 38 patients in the placebo group, most often headache (13%) and upper respiratory tract infection (13%).
The study was funded by Novartis. Dr. Heymsfield has reported receiving personal fees from Tanita and Medifast outside the submitted work. Disclosures for the other authors are listed in the article. Dr. Kaplan has reported previously serving as a scientific consultant to Novartis.
A version of this article first appeared on Medscape.com.