Study S000715

A Randomized, Double-Blind, Placebo-Controlled Multi-Center Study of Intravenous Bimagrumab, Alone or in Addition to Open Label Subcutaneous Semaglutide, to Investigate the Efficacy and Safety in Overweight or Obese Men and Women

Included trial: extracted data ClinicalTrials.gov record Study Protocol (PDF)Statistical Analysis Plan (PDF)

Registration

Registration: NCT05616013
Study type: INTERVENTIONAL
Allocation: RANDOMIZED
Phase: PHASE2
Masking: DOUBLE
Status: COMPLETED
Enrollment: 507
Start: 2022-11-16
Primary completion: 2024-05-16
Lead sponsor: Eli Lilly and Company
Conditions: Obesity; Obese; Overweight or Obesity
Interventions: BIOLOGICAL:Bimagrumab; DRUG:Semaglutide; OTHER:Placebo
Results posted: TRUE
Individual participant data sharing: YES
Secondary identifiers: OTHER:J4Z-MC-GIDA; OTHER:VER201-PH2-031

Registered primary outcomes

Change From Baseline in Body Weight at Week 48 [Baseline, Week 48]

Linked records (3)

Automatic links, confirmed or rejected during screening. A record citing this registration may be a secondary analysis, a commentary or a review that mentions the trial.

Record	Title	Year	Design	Identifiers	Link basis
R0015266	Bimagrumab plus semaglutide alone or in combination for the treatment of obesity: a randomized phase 2 trial. Heymsfield SB, Nature medicine	2026	Randomized trial	PMID 41772149 DOI	cites ClinicalTrials.gov:NCT05616013; registry reference DERIVED:41772149
R0039596	370-OR: Optimized Weight Loss with Bimagrumab—Reduced Fat Mass with Increased Muscle Mass by Appetite-Independent Mechanisms Kenneth M. Attie, Diabetes	2023	Other	DOI	cites ClinicalTrials.gov:NCT05616013
R0041756	OR10-03 Murine Bimagrumab Co-administration With Incretin Agonists Results In Additive Efficacy And Superior Quality Weight Loss In The Mouse Diet-induced Obesity Model Kevin Nguyen, Journal of the Endocrine Society	2023	Preclinical	DOI	cites ClinicalTrials.gov:NCT05616013