Phase 2
Completed N=507
Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese
Obesity · Obese · Overweight or Obesity
Source: ClinicalTrials.gov NCT05616013 ↗
Enrolled (actual)
507
Serious AEs
7.0%
Results posted
Jul 2025
Primary outcomePrimary: Change From Baseline in Body Weight at Week 48 — -3.31; -5.99; -9.25; -9.76 kilogram (kg) — p=<0.001
Summary
A phase 2 study to assess the efficacy of bimagrumab alone or in addition to semaglutide to assess efficacy and safety in overweight or obese men and women
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Body Weight at Week 48 |
-3.31; -5.99; -9.25; -9.76; -14.24; -12.73 | <0.001 sig |
| SECONDARY Change From Baseline in Waist Circumference at Week 48 |
-4.62; -7.31; -9.10; -8.74; -12.14; -12.41 | — |
| SECONDARY Change From Baseline in Waist Circumference at Week 72 |
— | — |
| SECONDARY Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48 |
-1.9; -5.7; -8.6; -6.7; -9.6; -11.2 | — |
| SECONDARY Change From Baseline in Total Body Fat Mass in kg at Week 72 |
— | — |
| SECONDARY Change From Baseline in Body Fat Percentage at Week 48 |
-1.02; -3.42; -5.23; -3.27; -4.18; -6.25 | — |
| SECONDARY Change From Baseline in Body Fat Percentage at Week 72 |
— | — |
| SECONDARY Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48 |
-0.0; -0.3; -0.4; -0.3; -0.4; -0.5 | — |
| SECONDARY Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72 |
— | — |
| SECONDARY Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48 |
47.1; 60.5; 67.6; 62.6; 79.3; 81.9 | — |
| SECONDARY Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48 |
38.8; 51.8; 68.8; 67.8; 88.2; 82.9 | — |
| SECONDARY Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48 |
45.3; 74.4; 79.3; 75.7; 90.6; 88.5 | — |
| SECONDARY Percentage of Participants With Reduction in Fat Mass ≥ 10% With <5% Decrease (or an Increase) in Lean Mass by DXA at Week 48 |
18.1; 55.9; 58.3; 26.3; 20.4; 52.6 | — |
| SECONDARY Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48 |
14.55; 26.79; 40.35; 41.82; 50.00; 62.50 | — |
| SECONDARY Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48 |
-2.78; -5.64; -7.59; -6.95; -10.08; -10.26 | — |
| SECONDARY Change From Baseline in Body Fat Mass by BIA at Week 72 |
— | — |
| SECONDARY Change From Baseline in Body Fat Percentage by BIA at Week 48 |
-1.69; -3.04; -4.21; -3.42; -4.71; -5.54 | — |
| SECONDARY Change From Baseline in Body Fat Percentage by BIA at Week 72 |
— | — |
| SECONDARY Change From Baseline in Lean Mass by DXA at Week 48 |
-0.5; 0.5; 0.4; -2.6; -3.9; -1.1 | — |
| SECONDARY Change From Baseline in Lean Mass by DXA at Week 72 |
— | — |
| SECONDARY Change From Baseline in Lean Body Mass Percentage by DXA at Week 48 |
0.94; 3.38; 5.05; 3.03; 3.81; 5.94 | — |
| SECONDARY Change From Baseline in Lean Body Mass Percentage by DXA at Week 72 |
— | — |
| SECONDARY Change From Baseline in Appendicular Lean Mass by DXA at Week 48 |
-0.3; 0.3; 0.2; -1.2; -2.0; -0.5 | — |
| SECONDARY Change From Baseline in Appendicular Lean Mass by DXA at Week 72 |
— | — |
| SECONDARY Change From Baseline in Lean Mass (kg) by BIA at Week 48 |
-0.71; -0.62; -1.50; -2.97; -3.99; -2.30 | — |
| SECONDARY Change From Baseline in Lean Mass (kg) by BIA at Week 72 |
— | — |
| SECONDARY Change From Baseline in Percentage Lean Body Mass by BIA at Week 48 |
2.16; 2.80; 4.17; 3.75; 4.79; 5.42 | — |
| SECONDARY Change From Baseline in Percentage Lean Body Mass by BIA at Week 72 |
— | — |
| SECONDARY Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48 |
0; 0; 0; 0; 0; 0 | — |
| SECONDARY Percentage of Participants With Baseline Waist-to-Height Ratio (WtHR) Category of <0.5 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 |
— | — |
| SECONDARY Percentage of Participants With Baseline WtHR Category of 0.5-0.59 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 |
0; 0; 50.0; 0; 0; 25.0 | — |
| SECONDARY Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48 |
0; 0; 5.4; 2.6; 2.1; 0 | — |
| SECONDARY Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48 |
-0.0; -0.2; -0.2; -0.3; -0.4; -0.3 | — |
| SECONDARY Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24 |
7.162; 9.211; 14.342; 12.500; 10.435; 12.927 | — |
| SECONDARY Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24 |
6.577; 4.086; 12.193; 13.222; 11.153; 12.124 | — |
| SECONDARY Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48 |
11.5; 10.8; 12.1; 10.0; 11.6; 14.6 | — |
| SECONDARY Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48 |
10.9; 8.5; 11.6; 11.7; 13.5; 14.8 | — |
| SECONDARY Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score and Total Score at Week 72 |
— | — |
| SECONDARY Change From Baseline in Impact of Weight on Quality of Life-Lite-Clinical Trials Version (IWQOL-Lite-CT) Physical Function Score and Total Score at Week 24 |
7.973; 13.289; 13.974; 16.667; 17.447; 14.659 | — |
| SECONDARY Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48 |
13.3; 15.6; 16.1; 15.3; 19.5; 18.7 | — |
| SECONDARY Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 72 |
— | — |
Eligibility Criteria
Key Inclusion Criteria
- A written informed consent must be obtained before any study-related assessments are performed.
- Men and women between 18 and 80 years, inclusive; women of child-bearing potential (defined as those who are not post-menopausal or post-surgical sterilization) must meet both of the following criteria:
- Two negative pregnancy tests (at screening and at randomization, prior to dosing)
- Use of intrauterine device, from at least 3 months before the baseline visit through at least 4 months after the last dose of bimagrumab/placebo i.v., and an additional contraceptive (barrier) method from screening through at least 4 months after the last dose of bimagrumab/placebo i.v.
- Body mass index (BMI) ≥ 30 or BMI ≥ 27 with one or more obesity-associated comorbidities (e.g., hypertension, insulin resistance, sleep apnea, or dyslipidemia)
- Stable body weight (± 5 kg) within 90 days of screening, and body weight 250 mL) within 14 days prior to the first dose
- Any disorder, unwillingness, or inability not covered by any of the other exclusion criteria, which in the Investigator's opinion, might jeopardize the participant's safety or compliance with the protocol
Data sourced from ClinicalTrials.gov (NCT05616013). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.