← Trials/Trial dossier/NCT05616013

CompletedPhase 2Results posted

Safety and Efficacy of Bimagrumab and Semaglutide in Adults Who Are Overweight or Obese

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

Asset

Semaglutide

GLP-1 agonist

Listed sites

26

Recruiting sites

Enrollment

507

actual

Study population

Obesity / overweight

Key I/E criterion

BMI ≥30

Primary endpoint

Body weight, absolute change (kg)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05616013
Org study ID18828
Secondary IDJ4Z-MC-GIDAEli Lilly and Company
Secondary IDVER201-PH2-031Versanis

Timeline

Milestones

Study first posted2022-11-14actual
Study start2022-11-16actual
Primary completion2024-05-16actual
Study completion2025-06-14actual
Last update posted2025-07-18actual
Results first posted2025-07-18actual

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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 <150 kg
Have a history of at least one self-reported unsuccessful behavioral effort to lose body weight
Able to communicate well with the Investigator, comply with the study requirements and adhere to the diet and activity programs for the study duration

Key Exclusion Criteria:

History of, or known hypersensitivity to, monoclonal antibody drugs or a contraindication to semaglutide (Ozempic® or Wegovy®)
Use of other investigational drugs at the time of enrollment or within 30 days or 5 half-lives of enrollment, whichever is longer, or longer if required by local regulations
Treatment with any medication for the indication of obesity within the past 30 days before screening
Diagnosis of diabetes requiring current use of any antidiabetic drug or HbA1c ≥ 6.5% Note: Metabolic syndrome is not an exclusion, even if managed with an anti-diabetic drug such as metformin or an SGLT2 inhibitor. A diagnosis of prediabetes or impaired glucose tolerance managed exclusively with non-pharmacologic approaches (e.g., diet and exercise) is not an exclusion.
Any chronic infections likely to interfere with study conduct or interpretation such as hepatitis B (HBV), hepatitis C (HCV), or human immunodeficiency virus (HIV). History of hepatitis A or hepatitis C successfully treated is not exclusionary. Active COVID-19 infection.
Donation or loss of 400 mL or more of blood within 8 weeks prior to initial dosing, or longer if required by local regulation, or plasma donation (> 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

Endpoints (82)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition
64
Patient-reported / QoL
16
Glycemic / diabetes
2

Weight & body composition

64 endpoints
Primary/registry result

Change From Baseline in Body Weight at Week 48

Time frame:Baseline, Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kilogram (kg)95% CI
Placebo-3.31
Bimagrumab 10 mg/kg-5.99
Bimagrumab 30 mg/kg-9.25
Placebo + Semaglutide 1.0 mg-9.76
Placebo + Semaglutide 2.4 mg-14.24
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg-12.73
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg-14.31
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg-13.86
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg-17.79
LS Mean Change difference-14.595% CI-18.0-11.0p<0.001ANCOVA

Bima 30mg/kg + Sema 2.4mg vs Placebo

LS Mean Change difference-10.595% CI-14.0-7.09p<0.001ANCOVA

Bima 30mg/kg + Sema 1.0mg vs Placebo

LS Mean Change difference-11.095% CI-14.4-7.55p<0.001ANCOVA

Bima 10mg/kg + Sema 2.4mg vs Placebo

LS Mean Change difference-9.4195% CI-12.9-5.93p<.001ANCOVA

Bima 10mg/kg + Sema 1.0mg vs Placebo

LS Mean Change difference-10.995% CI-14.4-7.46p<0.001ANCOVA

Sema 2.4mg vs Placebo

LS Mean Change difference-6.4595% CI-9.96-2.94p<0.001ANCOVA

Sema 1.0mg vs Placebo

LS Mean Change difference-5.9495% CI-9.47-2.41p<0.001ANCOVA

Bima 30mg/kg vs Placebo

LS Mean Change difference-2.6895% CI-6.180.82p0.133ANCOVA

Bima 10mg/kg vs Placebo

Primary/protocol endpoint

Change From Baseline in Body Weight at Week 48

Time frame:Baseline, Week 48

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/registry result

Change From Baseline in Waist Circumference at Week 48

Time frame:Baseline, Week 48

Waist circumference, change

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), centimeter (cm)95% CI
Placebo-4.62
Bimagrumab 10 mg/kg-7.31
Bimagrumab 30 mg/kg-9.10
Placebo + Semaglutide 1.0 mg-8.74
Placebo + Semaglutide 2.4 mg-12.14
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg-12.41
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg-13.35
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg-13.64
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg-15.78
Secondary/registry result

Change From Baseline in Waist Circumference at Week 72

Time frame:Baseline, Week 72

Waist circumference, change

change from baseline, improvement

Secondary/registry result

Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48

Time frame:Baseline, Week 48

Total fat mass

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kg95% CI
Placebo-1.9
Bimagrumab 10 mg/kg-5.7
Bimagrumab 30 mg/kg-8.6
Placebo + Semaglutide 1.0 mg-6.7
Placebo + Semaglutide 2.4 mg-9.6
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg-11.2
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg-11.9
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg-12.2
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg-15.6
Secondary/registry result

Change From Baseline in Total Body Fat Mass in kg at Week 72

Time frame:Baseline, Week 72

Total fat mass

change from baseline, improvement

Secondary/registry result

Change From Baseline in Body Fat Percentage at Week 48

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), percentage of body fat95% CI
Placebo-1.02
Bimagrumab 10 mg/kg-3.42
Bimagrumab 30 mg/kg-5.23
Placebo + Semaglutide 1.0 mg-3.27
Placebo + Semaglutide 2.4 mg-4.18
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg-6.25
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg-7.13
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg-7.46
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg-9.30
Secondary/registry result

Change From Baseline in Body Fat Percentage at Week 72

Time frame:Baseline, Week 72

Total fat mass

change from baseline, improvement

Secondary/registry result

Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kg95% CI
PlaceboVAT-0.0
SAT-0.05
Trunk fat mass-0.94
Bimagrumab 10 mg/kgVAT-0.3
SAT-0.37
Trunk fat mass-3.54
Bimagrumab 30 mg/kgVAT-0.4
SAT-0.54
Trunk fat mass-5.44
Placebo + Semaglutide 1.0 mgVAT-0.3
SAT-0.43
Trunk fat mass-3.83
Placebo + Semaglutide 2.4 mgVAT-0.4
SAT-0.64
Trunk fat mass-5.48
Bimagrumab 10 mg/kg + Semaglutide 1.0 mgVAT-0.5
SAT-0.70
Trunk fat mass-6.69
Bimagrumab 10 mg/kg + Semaglutide 2.4 mgVAT-0.6
SAT-0.84
Trunk fat mass-7.46
Bimagrumab 30 mg/kg + Semaglutide 1.0 mgVAT-0.6
SAT-0.81
Trunk fat mass-7.51
Bimagrumab 30 mg/kg + Semaglutide 2.4 mgVAT-0.7
SAT-1.05
Trunk fat mass-9.19
Secondary/registry result

Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72

Time frame:Baseline, Week 72

change from baseline, improvement

componentsVisceral fat, change, Subcutaneous fat, change, Total fat mass

Secondary/registry result

Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48

Time frame:Week 48

Waist circumference, change

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Placebo47.1
Bimagrumab 10 mg/kg60.5
Bimagrumab 30 mg/kg67.6
Placebo + Semaglutide 1.0 mg62.6
Placebo + Semaglutide 2.4 mg79.3
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg81.9
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg84.5
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg81.6
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg86.5
Secondary/registry result

Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48

Time frame:Week 48

≥15% weight-loss responders

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
PlaceboReduction in ≥ 5% Body Weight38.8
Reduction in ≥ 10% Body Weight10.4
Reduction in ≥ 15% Body Weight5.3
Bimagrumab 10 mg/kgReduction in ≥ 5% Body Weight51.8
Reduction in ≥ 10% Body Weight25.0
Reduction in ≥ 15% Body Weight11.7
Bimagrumab 30 mg/kgReduction in ≥ 5% Body Weight68.8
Reduction in ≥ 10% Body Weight39.3
Reduction in ≥ 15% Body Weight23.3
Placebo + Semaglutide 1.0 mgReduction in ≥ 5% Body Weight67.8
Reduction in ≥ 10% Body Weight43.4
Reduction in ≥ 15% Body Weight30.3
Placebo + Semaglutide 2.4 mgReduction in ≥ 5% Body Weight88.2
Reduction in ≥ 10% Body Weight74.8
Reduction in ≥ 15% Body Weight43.4
Bimagrumab 10 mg/kg + Semaglutide 1.0 mgReduction in ≥ 5% Body Weight82.9
Reduction in ≥ 10% Body Weight54.9
Reduction in ≥ 15% Body Weight32.2
Bimagrumab 10 mg/kg + Semaglutide 2.4 mgReduction in ≥ 5% Body Weight84.2
Reduction in ≥ 10% Body Weight72.1
Reduction in ≥ 15% Body Weight41.6
Bimagrumab 30 mg/kg + Semaglutide 1.0 mgReduction in ≥ 5% Body Weight83.9
Reduction in ≥ 10% Body Weight66.2
Reduction in ≥ 15% Body Weight47.7
Bimagrumab 30 mg/kg + Semaglutide 2.4 mgReduction in ≥ 5% Body Weight86.1
Reduction in ≥ 10% Body Weight79.2
Reduction in ≥ 15% Body Weight63.9
Secondary/registry result

Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48

Time frame:Week 48

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Placebo≥ 5% reduction in Fat Mass45.3
≥ 10% reduction in Fat Mass25.9
≥ 15% reduction in Fat Mass12.7
Bimagrumab 10 mg/kg≥ 5% reduction in Fat Mass74.4
≥ 10% reduction in Fat Mass65.1
≥ 15% reduction in Fat Mass39.4
Bimagrumab 30 mg/kg≥ 5% reduction in Fat Mass79.3
≥ 10% reduction in Fat Mass68.3
≥ 15% reduction in Fat Mass54.8
Placebo + Semaglutide 1.0 mg≥ 5% reduction in Fat Mass75.7
≥ 10% reduction in Fat Mass59.5
≥ 15% reduction in Fat Mass47.8
Placebo + Semaglutide 2.4 mg≥ 5% reduction in Fat Mass90.6
≥ 10% reduction in Fat Mass83.2
≥ 15% reduction in Fat Mass76.1
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg≥ 5% reduction in Fat Mass88.5
≥ 10% reduction in Fat Mass82.7
≥ 15% reduction in Fat Mass75.7
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg≥ 5% reduction in Fat Mass86.4
≥ 10% reduction in Fat Mass79.5
≥ 15% reduction in Fat Mass75.9
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg≥ 5% reduction in Fat Mass87.9
≥ 10% reduction in Fat Mass82.1
≥ 15% reduction in Fat Mass73.5
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg≥ 5% reduction in Fat Mass90.0
≥ 10% reduction in Fat Mass87.1
≥ 15% reduction in Fat Mass84.1
Secondary/registry result

Percentage of Participants With Reduction in Fat Mass ≥ 10% With <5% Decrease (or an Increase) in Lean Mass by DXA at Week 48

Time frame:Week 48

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
Placebo18.1
Bimagrumab 10 mg/kg55.9
Bimagrumab 30 mg/kg58.3
Placebo + Semaglutide 1.0 mg26.3
Placebo + Semaglutide 2.4 mg20.4
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg52.6
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg52.9
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg63.7
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg58.9
Secondary/registry result

Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48

Time frame:Week 48

threshold achievement, improvement

componentsBody weight, absolute change (kg), Total fat mass, Lean mass

Posted result

GroupValue (number), percentage of participants95% CI
Placebo>5kg Weight Loss and Fat Loss Index >70 %14.55
>5kg Weight Loss and Fat Loss Index >80 %12.73
>5kg Weight Loss and Fat Loss Index >90 %3.64
Bimagrumab 10 mg/kg>5kg Weight Loss and Fat Loss Index >70 %26.79
>5kg Weight Loss and Fat Loss Index >80 %23.21
>5kg Weight Loss and Fat Loss Index >90 %19.64
Bimagrumab 30 mg/kg>5kg Weight Loss and Fat Loss Index >70 %40.35
>5kg Weight Loss and Fat Loss Index >80 %36.84
>5kg Weight Loss and Fat Loss Index >90 %35.09
Placebo + Semaglutide 1.0 mg>5kg Weight Loss and Fat Loss Index >70 %41.82
>5kg Weight Loss and Fat Loss Index >80 %16.36
>5kg Weight Loss and Fat Loss Index >90 %12.73
Placebo + Semaglutide 2.4 mg>5kg Weight Loss and Fat Loss Index >70 %50.00
>5kg Weight Loss and Fat Loss Index >80 %17.86
>5kg Weight Loss and Fat Loss Index >90 %5.36
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg>5kg Weight Loss and Fat Loss Index >70 %62.50
>5kg Weight Loss and Fat Loss Index >80 %57.14
>5kg Weight Loss and Fat Loss Index >90 %42.86
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg>5kg Weight Loss and Fat Loss Index >70 %65.45
>5kg Weight Loss and Fat Loss Index >80 %56.36
>5kg Weight Loss and Fat Loss Index >90 %41.82
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg>5kg Weight Loss and Fat Loss Index >70 %64.29
>5kg Weight Loss and Fat Loss Index >80 %53.57
>5kg Weight Loss and Fat Loss Index >90 %46.43
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg>5kg Weight Loss and Fat Loss Index >70 %72.73
>5kg Weight Loss and Fat Loss Index >80 %61.82
>5kg Weight Loss and Fat Loss Index >90 %41.82
Secondary/registry result

Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48

Time frame:Baseline, Week 48

Total fat mass

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kg95% CI
Placebo-2.78
Bimagrumab 10 mg/kg-5.64
Bimagrumab 30 mg/kg-7.59
Placebo + Semaglutide 1.0 mg-6.95
Placebo + Semaglutide 2.4 mg-10.08
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg-10.26
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg-11.72
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg-11.71
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg-13.74
Secondary/registry result

Change From Baseline in Body Fat Mass by BIA at Week 72

Time frame:Baseline, Week 72

Total fat mass

change from baseline, improvement

Secondary/registry result

Change From Baseline in Body Fat Percentage by BIA at Week 48

Time frame:Baseline, Week 48

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), percentage of body fat95% CI
Placebo-1.69
Bimagrumab 10 mg/kg-3.04
Bimagrumab 30 mg/kg-4.21
Placebo + Semaglutide 1.0 mg-3.42
Placebo + Semaglutide 2.4 mg-4.71
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg-5.54
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg-6.77
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg-6.81
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg-7.40
Secondary/registry result

Change From Baseline in Body Fat Percentage by BIA at Week 72

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/registry result

Change From Baseline in Lean Mass by DXA at Week 48

Time frame:Baseline, Week 48

Lean mass

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kg95% CI
Placebo-0.5
Bimagrumab 10 mg/kg0.5
Bimagrumab 30 mg/kg0.4
Placebo + Semaglutide 1.0 mg-2.6
Placebo + Semaglutide 2.4 mg-3.9
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg-1.1
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg-1.2
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg-0.5
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg-1.3
Secondary/registry result

Change From Baseline in Lean Mass by DXA at Week 72

Time frame:Baseline, Week 72

Lean mass

change from baseline, improvement

Secondary/registry result

Change From Baseline in Lean Body Mass Percentage by DXA at Week 48

Time frame:Baseline, Week 48

Lean mass

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), percentage of body mass95% CI
Placebo0.94
Bimagrumab 10 mg/kg3.38
Bimagrumab 30 mg/kg5.05
Placebo + Semaglutide 1.0 mg3.03
Placebo + Semaglutide 2.4 mg3.81
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg5.94
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg6.78
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg7.13
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg8.84
Secondary/registry result

Change From Baseline in Lean Body Mass Percentage by DXA at Week 72

Time frame:Baseline, Week 72

Lean mass

change from baseline, improvement

Secondary/registry result

Change From Baseline in Appendicular Lean Mass by DXA at Week 48

Time frame:Baseline, Week 48

Lean mass

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kg95% CI
Placebo-0.3
Bimagrumab 10 mg/kg0.3
Bimagrumab 30 mg/kg0.2
Placebo + Semaglutide 1.0 mg-1.2
Placebo + Semaglutide 2.4 mg-2.0
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg-0.5
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg-0.6
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg-0.4
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg-0.5
Secondary/registry result

Change From Baseline in Appendicular Lean Mass by DXA at Week 72

Time frame:Baseline, Week 72

Lean mass

change from baseline, improvement

Secondary/registry result

Change From Baseline in Lean Mass (kg) by BIA at Week 48

Time frame:Baseline, Week 48

Lean mass

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), kg95% CI
Placebo-0.71
Bimagrumab 10 mg/kg-0.62
Bimagrumab 30 mg/kg-1.50
Placebo + Semaglutide 1.0 mg-2.97
Placebo + Semaglutide 2.4 mg-3.99
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg-2.30
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg-2.50
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg-2.39
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg-3.79
Secondary/registry result

Change From Baseline in Lean Mass (kg) by BIA at Week 72

Time frame:Baseline, Week 72

Lean mass

change from baseline, improvement

Secondary/registry result

Change From Baseline in Percentage Lean Body Mass by BIA at Week 48

Time frame:Baseline, Week 48

Lean mass

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), percentage of body mass95% CI
Placebo2.16
Bimagrumab 10 mg/kg2.80
Bimagrumab 30 mg/kg4.17
Placebo + Semaglutide 1.0 mg3.75
Placebo + Semaglutide 2.4 mg4.79
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg5.42
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg6.62
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg6.08
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg6.95
Secondary/registry result

Change From Baseline in Percentage Lean Body Mass by BIA at Week 72

Time frame:Baseline, Week 72

Lean mass

change from baseline, improvement

Secondary/registry result

Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48

Time frame:Baseline, Week 48

categorical status, improvement

Posted result

GroupValue (number), percentage of participants95% CI
PlaceboHealthy weight (Baseline)0
Overweight (Baseline)1.8
Obesity class I (Baseline)29.1
Obesity class II (Baseline)40
Obesity class III (Baseline)29.1
Healthy weight (Week 48)0
Overweight (Week 48)11.4
Obesity class I (Week 48)37.1
Obesity class II (Week 48)31.4
Obesity class III (Week 48)20
Bimagrumab 10 mg/kgHealthy weight (Baseline)0
Overweight (Baseline)5.4
Obesity class I (Baseline)39.3
Obesity class II (Baseline)30.4
Obesity class III (Baseline)25
Healthy weight (Week 48)0
Overweight (Week 48)19.4
Obesity class I (Week 48)32.3
Obesity class II (Week 48)35.5
Obesity class III (Week 48)12.9
Bimagrumab 30 mg/kgHealthy weight (Baseline)0
Overweight (Baseline)1.8
Obesity class I (Baseline)29.8
Obesity class II (Baseline)38.6
Obesity class III (Baseline)29.8
Healthy weight (Week 48)2.7
Overweight (Week 48)21.6
Obesity class I (Week 48)43.2
Obesity class II (Week 48)21.6
Obesity class III (Week 48)10.8
Placebo + Semaglutide 1.0 mgHealthy weight (Baseline)0
Overweight (Baseline)14.5
Obesity class I (Baseline)27.3
Obesity class II (Baseline)27.3
Obesity class III (Baseline)30.9
Healthy weight (Week 48)17.8
Overweight (Week 48)28.9
Obesity class I (Week 48)17.8
Obesity class II (Week 48)17.8
Obesity class III (Week 48)17.8
Placebo + Semaglutide 2.4 mgHealthy weight (Baseline)0
Overweight (Baseline)5.4
Obesity class I (Baseline)35.7
Obesity class II (Baseline)32.1
Obesity class III (Baseline)26.8
Healthy weight (Week 48)3.9
Overweight (Week 48)33.3
Obesity class I (Week 48)51.0
Obesity class II (Week 48)7.8
Obesity class III (Week 48)3.9
Bimagrumab 10 mg/kg + Semaglutide 1.0 mgHealthy weight (Baseline)0
Overweight (Baseline)3.6
Obesity class I (Baseline)28.6
Obesity class II (Baseline)30.4
Obesity class III (Baseline)37.5
Healthy weight (Week 48)2.4
Overweight (Week 48)31.7
Obesity class I (Week 48)31.7
Obesity class II (Week 48)26.8
Obesity class III (Week 48)7.3
Bimagrumab 10 mg/kg + Semaglutide 2.4 mgHealthy weight (Baseline)0
Overweight (Baseline)9.1
Obesity class I (Baseline)27.3
Obesity class II (Baseline)29.1
Obesity class III (Baseline)34.5
Healthy weight (Week 48)10
Overweight (Week 48)25
Obesity class I (Week 48)37.5
Obesity class II (Week 48)22.5
Obesity class III (Week 48)5
Bimagrumab 30 mg/kg + Semaglutide 1.0 mgHealthy weight (Baseline)0
Overweight (Baseline)1.8
Obesity class I (Baseline)25.0
Obesity class II (Baseline)50
Obesity class III (Baseline)23.2
Healthy weight (Week 48)7
Overweight (Week 48)25.6
Obesity class I (Week 48)53.5
Obesity class II (Week 48)11.6
Obesity class III (Week 48)2.3
Bimagrumab 30 mg/kg + Semaglutide 2.4 mgHealthy weight (Baseline)0
Overweight (Baseline)5.5
Obesity class I (Baseline)34.5
Obesity class II (Baseline)27.3
Obesity class III (Baseline)32.7
Healthy weight (Week 48)11.6
Overweight (Week 48)37.2
Obesity class I (Week 48)27.9
Obesity class II (Week 48)14
Obesity class III (Week 48)9.3
Secondary/registry result

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

Time frame:Baseline up to 48 weeks

threshold achievement, improvement

Secondary/registry result

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

Time frame:Baseline up to 48 weeks

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
PlaceboWtHR Category: <0.50
WtHR Category: 0.5-0.5960.0
WtHR Category: ≥0.640.0
Bimagrumab 10 mg/kgWtHR Category: <0.50
WtHR Category: 0.5-0.59100.0
WtHR Category: ≥0.60
Placebo + Semaglutide 1.0 mgWtHR Category: <0.550.0
WtHR Category: 0.5-0.5950.0
WtHR Category: ≥0.60
Placebo + Semaglutide 2.4 mgWtHR Category: <0.50
WtHR Category: 0.5-0.5966.7
WtHR Category: ≥0.633.3
Bimagrumab 10 mg/kg + Semaglutide 1.0 mgWtHR Category: <0.50
WtHR Category: 0.5-0.59100.0
WtHR Category: ≥0.60
Bimagrumab 30 mg/kg + Semaglutide 2.4 mgWtHR Category: <0.525.0
WtHR Category: 0.5-0.5975.0
WtHR Category: ≥0.60
Secondary/registry result

Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48

Time frame:Baseline up to 48 weeks

threshold achievement, improvement

Posted result

GroupValue (number), percentage of participants95% CI
PlaceboWtHR Category: <0.50
WtHR Category: 0.5-0.5920.0
WtHR Category: ≥0.680.0
Bimagrumab 10 mg/kgWtHR Category: <0.50
WtHR Category: 0.5-0.5917.9
WtHR Category: ≥0.682.1
Bimagrumab 30 mg/kgWtHR Category: <0.55.4
WtHR Category: 0.5-0.5921.6
WtHR Category: ≥0.673.0
Placebo + Semaglutide 1.0 mgWtHR Category: <0.52.6
WtHR Category: 0.5-0.5925.6
WtHR Category: ≥0.671.8
Placebo + Semaglutide 2.4 mgWtHR Category: <0.52.1
WtHR Category: 0.5-0.5931.3
WtHR Category: ≥0.666.7
Bimagrumab 10 mg/kg + Semaglutide 1.0 mgWtHR Category: <0.50
WtHR Category: 0.5-0.5938.5
WtHR Category: ≥0.661.5
Bimagrumab 10 mg/kg + Semaglutide 2.4 mgWtHR Category: <0.57.7
WtHR Category: 0.5-0.5938.5
WtHR Category: ≥0.653.8
Bimagrumab 30 mg/kg + Semaglutide 1.0 mgWtHR Category: <0.52.3
WtHR Category: 0.5-0.5951.2
WtHR Category: ≥0.646.5
Bimagrumab 30 mg/kg + Semaglutide 2.4 mgWtHR Category: <0.515.4
WtHR Category: 0.5-0.5935.9
WtHR Category: ≥0.648.7
Secondary/protocol endpoint

Change From Baseline in Waist Circumference at Week 48

Time frame:Baseline, Week 48

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference at Week 72

Time frame:Baseline, Week 72

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Total Body Fat Mass in Kilograms (kg) at Week 48

Time frame:Baseline, Week 48

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Total Body Fat Mass in kg at Week 72

Time frame:Baseline, Week 72

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Fat Percentage at Week 48

Time frame:Baseline, Week 48

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Fat Percentage at Week 72

Time frame:Baseline, Week 72

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Visceral Adipose Tissue (VAT), Subcutaneous Adipose Tissue (SAT) and Trunk Fat Mass by DXA at Week 48

Time frame:Baseline, Week 48

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in VAT, SAT and Trunk Fat Mass by DXA at Week 72

Time frame:Baseline, Week 72

change from baseline, improvement

componentsVisceral fat, change, Subcutaneous fat, change, Total fat mass

Secondary/protocol endpoint

Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48

Time frame:Week 48

Waist circumference, change

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With Reduction in Body Weight ≥ 5%, ≥ 10% and ≥15% at Week 48

Time frame:Week 48

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With Reduction in Fat Mass ≥ 5% ≥ 10% ≥ 15% by DXA at Week 48

Time frame:Week 48

Total fat mass

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With Reduction in Fat Mass ≥ 10% With <5% Decrease (or an Increase) in Lean Mass by DXA at Week 48

Time frame:Week 48

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving >5 kg Weight Loss and Fat Loss Index (FLI) of >70%, >80%, and >90% by DXA at Week 48

Time frame:Week 48

threshold achievement, improvement

componentsBody weight, absolute change (kg), Total fat mass, Lean mass

Secondary/protocol endpoint

Change From Baseline in Body Fat Mass by Bioelectrical Impedance Analysis (BIA) at Week 48

Time frame:Baseline, Week 48

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Fat Mass by BIA at Week 72

Time frame:Baseline, Week 72

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Fat Percentage by BIA at Week 48

Time frame:Baseline, Week 48

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Fat Percentage by BIA at Week 72

Time frame:Baseline, Week 72

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Lean Mass by DXA at Week 48

Time frame:Baseline, Week 48

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Lean Mass by DXA at Week 72

Time frame:Baseline, Week 72

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Lean Body Mass Percentage by DXA at Week 48

Time frame:Baseline, Week 48

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Lean Body Mass Percentage by DXA at Week 72

Time frame:Baseline, Week 72

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Appendicular Lean Mass by DXA at Week 48

Time frame:Baseline, Week 48

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Appendicular Lean Mass by DXA at Week 72

Time frame:Baseline, Week 72

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Lean Mass (kg) by BIA at Week 48

Time frame:Baseline, Week 48

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Lean Mass (kg) by BIA at Week 72

Time frame:Baseline, Week 72

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Percentage Lean Body Mass by BIA at Week 48

Time frame:Baseline, Week 48

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Percentage Lean Body Mass by BIA at Week 72

Time frame:Baseline, Week 72

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48

Time frame:Baseline, Week 48

categorical status, improvement

Secondary/protocol endpoint

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

Time frame:Baseline up to 48 weeks

categorical status, improvement

Secondary/protocol endpoint

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

Time frame:Baseline up to 48 weeks

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Participants With Baseline WtHR Category ≥0.6 Having Change From Baseline in Waist-to-Height Ratio (WHtR Ratio) Categories at Week 48

Time frame:Baseline up to 48 weeks

threshold achievement, improvement

Glycemic / diabetes

2 endpoints
Secondary/registry result

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48

Time frame:Baseline, 48 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Posted result

GroupValue (least_squares_mean), percentage of HbA1c95% CI
Placebo-0.0
Bimagrumab 10 mg/kg-0.2
Bimagrumab 30 mg/kg-0.2
Placebo + Semaglutide 1.0 mg-0.3
Placebo + Semaglutide 2.4 mg-0.4
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg-0.3
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg-0.5
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg-0.4
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg-0.4
Secondary/protocol endpoint

Change From Baseline in Glycated Hemoglobin (HbA1c) at Week 48

Time frame:Baseline, 48 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Patient-reported / QoL

16 endpoints
Secondary/registry result

Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24

Time frame:Baseline, Week 24

SF-36 physical

change from baseline, improvement

Posted result

GroupValue (mean), t-score95% CI
Placebo7.162
Bimagrumab 10 mg/kg9.211
Bimagrumab 30 mg/kg14.342
Placebo + Semaglutide 1.0 mg12.500
Placebo + Semaglutide 2.4 mg10.435
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg12.927
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg9.265
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg11.667
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg17.222
Secondary/registry result

Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24

Time frame:Baseline, Week 24

SF-36 total

change from baseline, improvement

Posted result

GroupValue (mean), score on a scale95% CI
Placebo6.577
Bimagrumab 10 mg/kg4.086
Bimagrumab 30 mg/kg12.193
Placebo + Semaglutide 1.0 mg13.222
Placebo + Semaglutide 2.4 mg11.153
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg12.124
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg7.484
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg11.506
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg17.060
Secondary/registry result

Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48

Time frame:Baseline, Week 48

SF-36 physical

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), t-score95% CI
Placebo11.5
Bimagrumab 10 mg/kg10.8
Bimagrumab 30 mg/kg12.1
Placebo + Semaglutide 1.0 mg10.0
Placebo + Semaglutide 2.4 mg11.6
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg14.6
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg13.0
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg13.0
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg16.1
Secondary/registry result

Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48

Time frame:Baseline, Week 48

SF-36 total

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), score on a scale95% CI
Placebo10.9
Bimagrumab 10 mg/kg8.5
Bimagrumab 30 mg/kg11.6
Placebo + Semaglutide 1.0 mg11.7
Placebo + Semaglutide 2.4 mg13.5
Bimagrumab 10 mg/kg + Semaglutide 1.0 mg14.8
Bimagrumab 10 mg/kg + Semaglutide 2.4 mg13.9
Bimagrumab 30 mg/kg + Semaglutide 1.0 mg14.4
Bimagrumab 30 mg/kg + Semaglutide 2.4 mg16.3
Secondary/registry result

Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score and Total Score at Week 72

Time frame:Baseline, Week 72

SF-36 total

change from baseline, improvement

Secondary/registry result

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

Time frame:Baseline, Week 24

IWQOL-Lite total

change from baseline, improvement

Posted result

GroupValue (mean), score on a scale95% CI
PlaceboPhysical Function Score7.973
Total score8.142
Bimagrumab 10 mg/kgPhysical Function Score13.289
Total score10.789
Bimagrumab 30 mg/kgPhysical Function Score13.974
Total score15.513
Placebo + Semaglutide 1.0 mgPhysical Function Score16.667
Total score17.639
Placebo + Semaglutide 2.4 mgPhysical Function Score17.447
Total score19.468
Bimagrumab 10 mg/kg + Semaglutide 1.0 mgPhysical Function Score14.659
Total score19.468
Bimagrumab 10 mg/kg + Semaglutide 2.4 mgPhysical Function Score12.105
Total score14.671
Bimagrumab 30 mg/kg + Semaglutide 1.0 mgPhysical Function Score18.690
Total score17.113
Bimagrumab 30 mg/kg + Semaglutide 2.4 mgPhysical Function Score21.667
Total score22.917
Secondary/registry result

Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48

Time frame:Baseline, Week 48

IWQOL-Lite physical

change from baseline, improvement

Posted result

GroupValue (least_squares_mean), score on a scale95% CI
PlaceboPhysical Function Score13.3
Total Score14.1
Bimagrumab 10 mg/kgPhysical Function Score15.6
Total Score14.7
Bimagrumab 30 mg/kgPhysical Function Score16.1
Total Score16.6
Placebo + Semaglutide 1.0 mgPhysical Function Score15.3
Total Score17.5
Placebo + Semaglutide 2.4 mgPhysical Function Score19.5
Total Score21.6
Bimagrumab 10 mg/kg + Semaglutide 1.0 mgPhysical Function Score18.7
Total Score22.4
Bimagrumab 10 mg/kg + Semaglutide 2.4 mgPhysical Function Score19.3
Total Score19.2
Bimagrumab 30 mg/kg + Semaglutide 1.0 mgPhysical Function Score21.6
Total Score21.2
Bimagrumab 30 mg/kg + Semaglutide 2.4 mgPhysical Function Score20.2
Total Score23.8
Secondary/registry result

Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 72

Time frame:Baseline, Week 72

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Quality of Life Short Form 36 Version 2 (SF-36v2) Acute Form Physical Functioning Domain Score at Week 24

Time frame:Baseline, Week 24

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score Week 24

Time frame:Baseline, Week 24

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score Week 48

Time frame:Baseline, Week 48

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Quality of Life SF-36v2 Acute Form Total Score at Week 48

Time frame:Baseline, Week 48

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Quality of Life SF-36v2 Acute Form Physical Functioning Domain Score and Total Score at Week 72

Time frame:Baseline, Week 72

SF-36 total

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline, Week 24

IWQOL-Lite physical

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 48

Time frame:Baseline, Week 48

IWQOL-Lite total

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in IWQOL-Lite-CT Physical Function Score and Total Score at Week 72

Time frame:Baseline, Week 72

IWQOL-Lite physical

change from baseline, improvement

Publications (2)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.