Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes

Summary

This study assessed the safety, pharmacokinetics and efficacy of bimagrumab when administered in overweight and obese patients with type 2 diabetes

Timeline

Start

2017-02-01

Primary completion

2019-03-21

Completion

2019-05-08

Outcome

Met primary endpoint

registry analysis (superiority test); BYM338 10 mg/kg vs Placebo; p <0.001; Mean Difference (Net) -7.31 (80% CI -8.48 to -6.14) NCT03005288 ↗

paper FM, -20.5% (-7.5 kg [80% CI, -8.3 to -6.6 kg]) vs -0.5% (-0.18 kg [80% CI, -0.99 to 0.63 kg]) (P < .001); PMID 33439265 ↗

Publications

• Heymsfield SB, Coleman LA, Miller R, Rooks DS, Laurent D, Petricoul O, Praestgaard J, Swan T, Wade T, Perry RG, Goodpaster BH, Roubenoff R. Effect of Bimagrumab vs Placebo on Body Fat Mass Among Adults With Type 2 Diabetes and Obesity: A Phase 2 Randomized Clinical Trial. JAMA Netw Open. 2021 Jan 4;4(1):e2033457. doi: 10.1001/jamanetworkopen.2020.33457.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bimagrumab	Monoclonal antibody	10 mg/kg	Intravenous

Indications