Trial results for a Phase 2 study investigating semaglutide in combination with bimagrumab for adults who are overweight or obese were posted on ClinicalTrials.gov on 2025-07-18. The study demonstrated that the highest dose combination of bimagrumab 30 mg/kg plus semaglutide 2.4 mg led to a mean body weight reduction of -17.79 kg at Week 48.
Background
This Phase 2 study investigated the safety and efficacy of bimagrumab alone or in addition to semaglutide for adults who are overweight or obese.
Trial design
The study (NCT05616013) was a Phase 2, randomized study that enrolled 507 adult participants who were diagnosed with obesity or were overweight. The trial assessed the efficacy and safety of bimagrumab alone or in combination with semaglutide. Participants were assigned to various treatment arms, including placebo, bimagrumab 10 mg/kg, bimagrumab 30 mg/kg, semaglutide 1.0 mg (with placebo), semaglutide 2.4 mg (with placebo), and combinations of bimagrumab at both doses with semaglutide 1.0 mg or 2.4 mg. The primary outcome measure was not specified in the posted results.
Key results
The key outcome measured was the change from baseline in body weight at Week 48. The least squares mean (LSM) changes in body weight were:
- Placebo: -3.31 kg (Standard Error: 1.39)
- Bimagrumab 10 mg/kg: -5.99 kg (Standard Error: 1.42)
- Bimagrumab 30 mg/kg: -9.25 kg (Standard Error: 1.33)
- Placebo + Semaglutide 1.0 mg: -9.76 kg (Standard Error: 1.25)
- Placebo + Semaglutide 2.4 mg: -14.24 kg (Standard Error: 1.17)
- Bimagrumab 10 mg/kg + Semaglutide 1.0 mg: -12.73 kg (Standard Error: 1.29)
- Bimagrumab 10 mg/kg + Semaglutide 2.4 mg: -14.31 kg (Standard Error: 1.34)
- Bimagrumab 30 mg/kg + Semaglutide 1.0 mg: -13.86 kg (Standard Error: 1.29)
- Bimagrumab 30 mg/kg + Semaglutide 2.4 mg: -17.79 kg (Standard Error: 1.29)
Changes from baseline in waist circumference at Week 48 were also reported for some groups:
- Placebo: -4.62 cm (Standard Error: 1.59)
- Bimagrumab 10 mg/kg: -7.31 cm (Standard Error: 1.74)
- Bimagrumab 30 mg/kg: -9.10 cm (Standard Error: 1.49)
Key analyses for LS Mean Change difference in body weight using ANCOVA showed:
- Bimagrumab 30 mg/kg + Semaglutide 2.4 mg vs Placebo: -14.5 kg (95.0% CI: -18.0 to -11.0), p-value: 0.001
- Bimagrumab 30 mg/kg + Semaglutide 1.0 mg vs Placebo: -10.5 kg (95.0% CI: -14.0 to -7.09), p-value: 0.001
- Bimagrumab 10 mg/kg + Semaglutide 2.4 mg vs Placebo: -11.0 kg (95.0% CI: -14.4 to -7.55), p-value: 0.001
- Bimagrumab 10 mg/kg + Semaglutide 1.0 mg vs Placebo: -9.41 kg (95.0% CI: -12.9 to -5.93), p-value: 0.001
- Semaglutide 2.4 mg vs Placebo: -10.9 kg (95.0% CI: -14.4 to -7.46), p-value: 0.001
- Semaglutide 1.0 mg vs Placebo: -6.45 kg (95.0% CI: -9.96 to -2.94), p-value: 0.001
What this means
The results from this Phase 2 study indicate that the combination of semaglutide and bimagrumab can lead to substantial body weight reduction in adults who are overweight or obese. Specifically, the combination of bimagrumab 30 mg/kg with semaglutide 2.4 mg demonstrated the largest mean weight loss of -17.79 kg, which was significantly greater than placebo and also numerically superior to semaglutide 2.4 mg alone (-14.24 kg). These findings suggest a potential synergistic effect or additive benefit of combining these two agents for weight management, warranting further investigation in later-phase trials.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05616013, titled "Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese," were posted on 2025-07-18 on clinicaltrials.gov.