Date: 2017-01-12
Type of information: Initiation of the trial
phase: 2
Announcement: initiation of the trial
Company: Novartis (Switzerland)
Product: bimagrumab (BYM338)
Action
mechanism: monoclonal antibody. Bimagrumab (BYM338) is a fully human monoclonal antibody developed to treat pathological muscle loss and weakness. Bimagrumab was developed by the Novartis Institutes for Biomedical Research (NIBR), in collaboration with MorphoSys, whose HuCAL library was used to identify the antibody. Bimagrumab binds with high affinity to type II activin receptors, preventing natural ligands from binding, including myostatin and activin. Bimagrumab stimulates muscle growth by blocking signaling from these inhibitory molecules.
Disease: obese patients with type 2 diabetes
Therapeutic area: Metabolic diseases
Country:
Trial
details: This study will assess the safety, pharmacokinetics and efficacy of bimagrumab when administered in obese patients with type 2 diabetes. ( NCT03005288)
Latest
news: * On January 12, 2017, MorphoSys announced that its partner Novartis will conduct a phase 2 clinical trial of the HuCAL antibody bimagrumab in obese patients with type 2 diabetes. According to information published on clinicaltrials.gov, the randomized, subject- and investigator-blinded study will enroll 60 obese adult patients with type 2 diabetes to assess the safety, pharmacokinetics and efficacy of intravenous bimagrumab compared to placebo. The study is not yet open for enrollment.
The study's primary outcome measures comprise the change in fat body mass at weeks 24 and 48. Secondary outcome measures include mean change from baseline in HbA1c, insulin resistance as measured by the homeostatic model assessment (HOMA-IR), fasting insulin and glucose.
