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Bimagrumab: Trials and FDA Status

Bimagrumab is a activin receptor antibody (muscle-sparing). This page tracks its trials, sponsor and FDA status, with a dated source for each milestone.

Medically reviewed by Juan Pablo Frías, MD · · DisclosureUpdated

Where it stands

US status
Investigational
Phase
Phase 2 (obesity)
Sponsor
Eli Lilly (earlier trials: Novartis)
Expected FDA decision
None announced
no primary source states a date (checked 2 Oct 2026)
Trial IDs (NCT)
NCT03005288, NCT05616013, NCT06643728
Results

Reported results

  • 2021Phase 2 in type 2 diabetes with obesity (JAMA Netw Open 2021): body fat mass at week 48“Changes at week 48 for bimagrumab vs placebo were as follows: 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])”pubmed.ncbi.nlm.nih.gov
  • 2026Phase 2 BELIEVE with semaglutide (Nat Med 2026): weight change at week 48“The least squares mean absolute changes in body weight at week 48 were -9.3 kg (bimagrumab 30 mg kg-1), -14.2 kg (semaglutide 2.4 mg) and -17.8 kg (bimagrumab 30 mg kg-1 plus semaglutide 2.4 mg-that is, high-dose combination) versus -3.3 kg (placebo)”pubmed.ncbi.nlm.nih.gov

Company-reported figures are labelled as such. Results in a trial population may not match results elsewhere.

Timeline

Milestones

  1. NCT06643728 (A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight; Phase 2): primary completion
  2. Published in Nature medicine (2026): Bimagrumab plus semaglutide alone or in combination for the treatment of obesity: a randomized phase 2 trial.
  3. NCT06643728 (A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight; Phase 2): study start
  4. NCT06643728 (A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight; Phase 2): first posted on ClinicalTrials.gov
  5. NCT05616013 (Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese; Phase 2): primary completion
  6. NCT05616013 (Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese; Phase 2): study start
  7. NCT05616013 (Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese; Phase 2): first posted on ClinicalTrials.gov
  8. Published in JAMA network open (2021): Effect of Bimagrumab vs Placebo on Body Fat Mass Among Adults With Type 2 Diabetes and Obesity: A Phase 2 Randomized Clinical Trial.
  9. NCT03005288 (Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes; Phase 2): primary completion
  10. NCT03005288 (Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes; Phase 2): study start
  11. NCT03005288 (Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes; Phase 2): first posted on ClinicalTrials.gov (estimated)

Sources

  1. 1Safety, Pharmacokinetics and Efficacy of Bimagrumab in Overweight and Obese Patients With Type 2 Diabetes (NCT03005288)ClinicalTrials.gov (U.S. National Library of Medicine) · 2016clinicaltrials.govAccessed 2 Oct 2026
  2. 2Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese (NCT05616013)ClinicalTrials.gov (U.S. National Library of Medicine) · 2022clinicaltrials.govAccessed 2 Oct 2026
  3. 3A Study to Investigate Weight Management With Bimagrumab (LY3985863) and Tirzepatide (LY3298176), Alone or in Combination, in Adults With Obesity or Overweight (NCT06643728)ClinicalTrials.gov (U.S. National Library of Medicine) · 2024clinicaltrials.govAccessed 2 Oct 2026
  4. 4Effect of Bimagrumab vs Placebo on Body Fat Mass Among Adults With Type 2 Diabetes and Obesity: A Phase 2 Randomized Clinical Trial.JAMA network open · 2021PMID 33439265Accessed 2 Oct 2026
  5. 5Bimagrumab plus semaglutide alone or in combination for the treatment of obesity: a randomized phase 2 trial.Nature medicine · 2026PMID 41772149Accessed 2 Oct 2026

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