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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
Lead sponsor
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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Eligibility criteria
Key Inclusion Criteria:
Key Exclusion Criteria:
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 endpointsChange From Baseline in Body Weight at Week 48
Time frame:Baseline, Week 48
Body weight, absolute change (kg)
change from baseline, improvement
Posted result
| Group | Value (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 | — |
Bima 30mg/kg + Sema 2.4mg vs Placebo
Bima 30mg/kg + Sema 1.0mg vs Placebo
Bima 10mg/kg + Sema 2.4mg vs Placebo
Bima 10mg/kg + Sema 1.0mg vs Placebo
Sema 2.4mg vs Placebo
Sema 1.0mg vs Placebo
Bima 30mg/kg vs Placebo
Bima 10mg/kg vs Placebo
Change From Baseline in Body Weight at Week 48
Time frame:Baseline, Week 48
Body weight, absolute change (kg)
change from baseline, improvement
Change From Baseline in Waist Circumference at Week 48
Time frame:Baseline, Week 48
Waist circumference, change
change from baseline, improvement
Posted result
| Group | Value (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 | — |
Change From Baseline in Waist Circumference at Week 72
Time frame:Baseline, Week 72
Waist circumference, change
change from baseline, improvement
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
| Group | Value (least_squares_mean), kg | 95% 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 | — |
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
Change From Baseline in Body Fat Percentage at Week 48
Time frame:Baseline, Week 48
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), percentage of body fat | 95% 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 | — |
Change From Baseline in Body Fat Percentage at Week 72
Time frame:Baseline, Week 72
Total fat mass
change from baseline, improvement
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
| Group | Value (least_squares_mean), kg | 95% 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 | — |
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
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
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Placebo | 47.1 | — |
| Bimagrumab 10 mg/kg | 60.5 | — |
| Bimagrumab 30 mg/kg | 67.6 | — |
| Placebo + Semaglutide 1.0 mg | 62.6 | — |
| Placebo + Semaglutide 2.4 mg | 79.3 | — |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | 81.9 | — |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | 84.5 | — |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | 81.6 | — |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | 86.5 | — |
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
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| PlaceboReduction in ≥ 5% Body Weight | 38.8 | — |
| Reduction in ≥ 10% Body Weight | 10.4 | — |
| Reduction in ≥ 15% Body Weight | 5.3 | — |
| Bimagrumab 10 mg/kgReduction in ≥ 5% Body Weight | 51.8 | — |
| Reduction in ≥ 10% Body Weight | 25.0 | — |
| Reduction in ≥ 15% Body Weight | 11.7 | — |
| Bimagrumab 30 mg/kgReduction in ≥ 5% Body Weight | 68.8 | — |
| Reduction in ≥ 10% Body Weight | 39.3 | — |
| Reduction in ≥ 15% Body Weight | 23.3 | — |
| Placebo + Semaglutide 1.0 mgReduction in ≥ 5% Body Weight | 67.8 | — |
| Reduction in ≥ 10% Body Weight | 43.4 | — |
| Reduction in ≥ 15% Body Weight | 30.3 | — |
| Placebo + Semaglutide 2.4 mgReduction in ≥ 5% Body Weight | 88.2 | — |
| Reduction in ≥ 10% Body Weight | 74.8 | — |
| Reduction in ≥ 15% Body Weight | 43.4 | — |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mgReduction in ≥ 5% Body Weight | 82.9 | — |
| Reduction in ≥ 10% Body Weight | 54.9 | — |
| Reduction in ≥ 15% Body Weight | 32.2 | — |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mgReduction in ≥ 5% Body Weight | 84.2 | — |
| Reduction in ≥ 10% Body Weight | 72.1 | — |
| Reduction in ≥ 15% Body Weight | 41.6 | — |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mgReduction in ≥ 5% Body Weight | 83.9 | — |
| Reduction in ≥ 10% Body Weight | 66.2 | — |
| Reduction in ≥ 15% Body Weight | 47.7 | — |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mgReduction in ≥ 5% Body Weight | 86.1 | — |
| Reduction in ≥ 10% Body Weight | 79.2 | — |
| Reduction in ≥ 15% Body Weight | 63.9 | — |
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
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Placebo≥ 5% reduction in Fat Mass | 45.3 | — |
| ≥ 10% reduction in Fat Mass | 25.9 | — |
| ≥ 15% reduction in Fat Mass | 12.7 | — |
| Bimagrumab 10 mg/kg≥ 5% reduction in Fat Mass | 74.4 | — |
| ≥ 10% reduction in Fat Mass | 65.1 | — |
| ≥ 15% reduction in Fat Mass | 39.4 | — |
| Bimagrumab 30 mg/kg≥ 5% reduction in Fat Mass | 79.3 | — |
| ≥ 10% reduction in Fat Mass | 68.3 | — |
| ≥ 15% reduction in Fat Mass | 54.8 | — |
| Placebo + Semaglutide 1.0 mg≥ 5% reduction in Fat Mass | 75.7 | — |
| ≥ 10% reduction in Fat Mass | 59.5 | — |
| ≥ 15% reduction in Fat Mass | 47.8 | — |
| Placebo + Semaglutide 2.4 mg≥ 5% reduction in Fat Mass | 90.6 | — |
| ≥ 10% reduction in Fat Mass | 83.2 | — |
| ≥ 15% reduction in Fat Mass | 76.1 | — |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg≥ 5% reduction in Fat Mass | 88.5 | — |
| ≥ 10% reduction in Fat Mass | 82.7 | — |
| ≥ 15% reduction in Fat Mass | 75.7 | — |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg≥ 5% reduction in Fat Mass | 86.4 | — |
| ≥ 10% reduction in Fat Mass | 79.5 | — |
| ≥ 15% reduction in Fat Mass | 75.9 | — |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg≥ 5% reduction in Fat Mass | 87.9 | — |
| ≥ 10% reduction in Fat Mass | 82.1 | — |
| ≥ 15% reduction in Fat Mass | 73.5 | — |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg≥ 5% reduction in Fat Mass | 90.0 | — |
| ≥ 10% reduction in Fat Mass | 87.1 | — |
| ≥ 15% reduction in Fat Mass | 84.1 | — |
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
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| Placebo | 18.1 | — |
| Bimagrumab 10 mg/kg | 55.9 | — |
| Bimagrumab 30 mg/kg | 58.3 | — |
| Placebo + Semaglutide 1.0 mg | 26.3 | — |
| Placebo + Semaglutide 2.4 mg | 20.4 | — |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | 52.6 | — |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | 52.9 | — |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | 63.7 | — |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | 58.9 | — |
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
| Group | Value (number), percentage of participants | 95% 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 | — |
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
| Group | Value (least_squares_mean), kg | 95% 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 | — |
Change From Baseline in Body Fat Mass by BIA at Week 72
Time frame:Baseline, Week 72
Total fat mass
change from baseline, improvement
Change From Baseline in Body Fat Percentage by BIA at Week 48
Time frame:Baseline, Week 48
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), percentage of body fat | 95% 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 | — |
Change From Baseline in Body Fat Percentage by BIA at Week 72
Time frame:Baseline, Week 72
change from baseline, improvement
Change From Baseline in Lean Mass by DXA at Week 48
Time frame:Baseline, Week 48
Lean mass
change from baseline, improvement
Posted result
| Group | Value (least_squares_mean), kg | 95% CI |
|---|---|---|
| Placebo | -0.5 | — |
| Bimagrumab 10 mg/kg | 0.5 | — |
| Bimagrumab 30 mg/kg | 0.4 | — |
| 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 | — |
Change From Baseline in Lean Mass by DXA at Week 72
Time frame:Baseline, Week 72
Lean mass
change from baseline, improvement
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
| Group | Value (least_squares_mean), percentage of body mass | 95% CI |
|---|---|---|
| Placebo | 0.94 | — |
| Bimagrumab 10 mg/kg | 3.38 | — |
| Bimagrumab 30 mg/kg | 5.05 | — |
| Placebo + Semaglutide 1.0 mg | 3.03 | — |
| Placebo + Semaglutide 2.4 mg | 3.81 | — |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | 5.94 | — |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | 6.78 | — |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | 7.13 | — |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | 8.84 | — |
Change From Baseline in Lean Body Mass Percentage by DXA at Week 72
Time frame:Baseline, Week 72
Lean mass
change from baseline, improvement
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
| Group | Value (least_squares_mean), kg | 95% CI |
|---|---|---|
| Placebo | -0.3 | — |
| Bimagrumab 10 mg/kg | 0.3 | — |
| Bimagrumab 30 mg/kg | 0.2 | — |
| 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 | — |
Change From Baseline in Appendicular Lean Mass by DXA at Week 72
Time frame:Baseline, Week 72
Lean mass
change from baseline, improvement
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
| Group | Value (least_squares_mean), kg | 95% 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 | — |
Change From Baseline in Lean Mass (kg) by BIA at Week 72
Time frame:Baseline, Week 72
Lean mass
change from baseline, improvement
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
| Group | Value (least_squares_mean), percentage of body mass | 95% CI |
|---|---|---|
| Placebo | 2.16 | — |
| Bimagrumab 10 mg/kg | 2.80 | — |
| Bimagrumab 30 mg/kg | 4.17 | — |
| Placebo + Semaglutide 1.0 mg | 3.75 | — |
| Placebo + Semaglutide 2.4 mg | 4.79 | — |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | 5.42 | — |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | 6.62 | — |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | 6.08 | — |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | 6.95 | — |
Change From Baseline in Percentage Lean Body Mass by BIA at Week 72
Time frame:Baseline, Week 72
Lean mass
change from baseline, improvement
Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48
Time frame:Baseline, Week 48
categorical status, improvement
Posted result
| Group | Value (number), percentage of participants | 95% 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 | — |
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
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
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| PlaceboWtHR Category: <0.5 | 0 | — |
| WtHR Category: 0.5-0.59 | 60.0 | — |
| WtHR Category: ≥0.6 | 40.0 | — |
| Bimagrumab 10 mg/kgWtHR Category: <0.5 | 0 | — |
| WtHR Category: 0.5-0.59 | 100.0 | — |
| WtHR Category: ≥0.6 | 0 | — |
| Placebo + Semaglutide 1.0 mgWtHR Category: <0.5 | 50.0 | — |
| WtHR Category: 0.5-0.59 | 50.0 | — |
| WtHR Category: ≥0.6 | 0 | — |
| Placebo + Semaglutide 2.4 mgWtHR Category: <0.5 | 0 | — |
| WtHR Category: 0.5-0.59 | 66.7 | — |
| WtHR Category: ≥0.6 | 33.3 | — |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mgWtHR Category: <0.5 | 0 | — |
| WtHR Category: 0.5-0.59 | 100.0 | — |
| WtHR Category: ≥0.6 | 0 | — |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mgWtHR Category: <0.5 | 25.0 | — |
| WtHR Category: 0.5-0.59 | 75.0 | — |
| WtHR Category: ≥0.6 | 0 | — |
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
| Group | Value (number), percentage of participants | 95% CI |
|---|---|---|
| PlaceboWtHR Category: <0.5 | 0 | — |
| WtHR Category: 0.5-0.59 | 20.0 | — |
| WtHR Category: ≥0.6 | 80.0 | — |
| Bimagrumab 10 mg/kgWtHR Category: <0.5 | 0 | — |
| WtHR Category: 0.5-0.59 | 17.9 | — |
| WtHR Category: ≥0.6 | 82.1 | — |
| Bimagrumab 30 mg/kgWtHR Category: <0.5 | 5.4 | — |
| WtHR Category: 0.5-0.59 | 21.6 | — |
| WtHR Category: ≥0.6 | 73.0 | — |
| Placebo + Semaglutide 1.0 mgWtHR Category: <0.5 | 2.6 | — |
| WtHR Category: 0.5-0.59 | 25.6 | — |
| WtHR Category: ≥0.6 | 71.8 | — |
| Placebo + Semaglutide 2.4 mgWtHR Category: <0.5 | 2.1 | — |
| WtHR Category: 0.5-0.59 | 31.3 | — |
| WtHR Category: ≥0.6 | 66.7 | — |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mgWtHR Category: <0.5 | 0 | — |
| WtHR Category: 0.5-0.59 | 38.5 | — |
| WtHR Category: ≥0.6 | 61.5 | — |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mgWtHR Category: <0.5 | 7.7 | — |
| WtHR Category: 0.5-0.59 | 38.5 | — |
| WtHR Category: ≥0.6 | 53.8 | — |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mgWtHR Category: <0.5 | 2.3 | — |
| WtHR Category: 0.5-0.59 | 51.2 | — |
| WtHR Category: ≥0.6 | 46.5 | — |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mgWtHR Category: <0.5 | 15.4 | — |
| WtHR Category: 0.5-0.59 | 35.9 | — |
| WtHR Category: ≥0.6 | 48.7 | — |
Change From Baseline in Waist Circumference at Week 48
Time frame:Baseline, Week 48
Waist circumference, change
change from baseline, improvement
Change From Baseline in Waist Circumference at Week 72
Time frame:Baseline, Week 72
Waist circumference, change
change from baseline, improvement
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
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
Change From Baseline in Body Fat Percentage at Week 48
Time frame:Baseline, Week 48
Total fat mass
change from baseline, improvement
Change From Baseline in Body Fat Percentage at Week 72
Time frame:Baseline, Week 72
Total fat mass
change from baseline, improvement
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
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
Percentage of Participants With Reduction in Waist Circumference ≥ 5 cm at Week 48
Time frame:Week 48
Waist circumference, change
threshold achievement, improvement
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
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
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
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
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
Change From Baseline in Body Fat Mass by BIA at Week 72
Time frame:Baseline, Week 72
Total fat mass
change from baseline, improvement
Change From Baseline in Body Fat Percentage by BIA at Week 48
Time frame:Baseline, Week 48
Total fat mass
change from baseline, improvement
Change From Baseline in Body Fat Percentage by BIA at Week 72
Time frame:Baseline, Week 72
change from baseline, improvement
Change From Baseline in Lean Mass by DXA at Week 48
Time frame:Baseline, Week 48
Lean mass
change from baseline, improvement
Change From Baseline in Lean Mass by DXA at Week 72
Time frame:Baseline, Week 72
Lean mass
change from baseline, improvement
Change From Baseline in Lean Body Mass Percentage by DXA at Week 48
Time frame:Baseline, Week 48
Lean mass
change from baseline, improvement
Change From Baseline in Lean Body Mass Percentage by DXA at Week 72
Time frame:Baseline, Week 72
Lean mass
change from baseline, improvement
Change From Baseline in Appendicular Lean Mass by DXA at Week 48
Time frame:Baseline, Week 48
Lean mass
change from baseline, improvement
Change From Baseline in Appendicular Lean Mass by DXA at Week 72
Time frame:Baseline, Week 72
Lean mass
change from baseline, improvement
Change From Baseline in Lean Mass (kg) by BIA at Week 48
Time frame:Baseline, Week 48
Lean mass
change from baseline, improvement
Change From Baseline in Lean Mass (kg) by BIA at Week 72
Time frame:Baseline, Week 72
Lean mass
change from baseline, improvement
Change From Baseline in Percentage Lean Body Mass by BIA at Week 48
Time frame:Baseline, Week 48
Lean mass
change from baseline, improvement
Change From Baseline in Percentage Lean Body Mass by BIA at Week 72
Time frame:Baseline, Week 72
Lean mass
change from baseline, improvement
Percentage of Participants With Body Mass Index (BMI) Categories at Baseline and Week 48
Time frame:Baseline, Week 48
categorical status, improvement
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
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
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 endpointsChange 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
| Group | Value (least_squares_mean), percentage of HbA1c | 95% 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 | — |
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 endpointsChange 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
| Group | Value (mean), t-score | 95% CI |
|---|---|---|
| Placebo | 7.162 | — |
| Bimagrumab 10 mg/kg | 9.211 | — |
| Bimagrumab 30 mg/kg | 14.342 | — |
| Placebo + Semaglutide 1.0 mg | 12.500 | — |
| Placebo + Semaglutide 2.4 mg | 10.435 | — |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | 12.927 | — |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | 9.265 | — |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | 11.667 | — |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | 17.222 | — |
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
| Group | Value (mean), score on a scale | 95% CI |
|---|---|---|
| Placebo | 6.577 | — |
| Bimagrumab 10 mg/kg | 4.086 | — |
| Bimagrumab 30 mg/kg | 12.193 | — |
| Placebo + Semaglutide 1.0 mg | 13.222 | — |
| Placebo + Semaglutide 2.4 mg | 11.153 | — |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | 12.124 | — |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | 7.484 | — |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | 11.506 | — |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | 17.060 | — |
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
| Group | Value (least_squares_mean), t-score | 95% CI |
|---|---|---|
| Placebo | 11.5 | — |
| Bimagrumab 10 mg/kg | 10.8 | — |
| Bimagrumab 30 mg/kg | 12.1 | — |
| Placebo + Semaglutide 1.0 mg | 10.0 | — |
| Placebo + Semaglutide 2.4 mg | 11.6 | — |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | 14.6 | — |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | 13.0 | — |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | 13.0 | — |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | 16.1 | — |
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
| Group | Value (least_squares_mean), score on a scale | 95% CI |
|---|---|---|
| Placebo | 10.9 | — |
| Bimagrumab 10 mg/kg | 8.5 | — |
| Bimagrumab 30 mg/kg | 11.6 | — |
| Placebo + Semaglutide 1.0 mg | 11.7 | — |
| Placebo + Semaglutide 2.4 mg | 13.5 | — |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mg | 14.8 | — |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mg | 13.9 | — |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mg | 14.4 | — |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mg | 16.3 | — |
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
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
| Group | Value (mean), score on a scale | 95% CI |
|---|---|---|
| PlaceboPhysical Function Score | 7.973 | — |
| Total score | 8.142 | — |
| Bimagrumab 10 mg/kgPhysical Function Score | 13.289 | — |
| Total score | 10.789 | — |
| Bimagrumab 30 mg/kgPhysical Function Score | 13.974 | — |
| Total score | 15.513 | — |
| Placebo + Semaglutide 1.0 mgPhysical Function Score | 16.667 | — |
| Total score | 17.639 | — |
| Placebo + Semaglutide 2.4 mgPhysical Function Score | 17.447 | — |
| Total score | 19.468 | — |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mgPhysical Function Score | 14.659 | — |
| Total score | 19.468 | — |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mgPhysical Function Score | 12.105 | — |
| Total score | 14.671 | — |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mgPhysical Function Score | 18.690 | — |
| Total score | 17.113 | — |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mgPhysical Function Score | 21.667 | — |
| Total score | 22.917 | — |
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
| Group | Value (least_squares_mean), score on a scale | 95% CI |
|---|---|---|
| PlaceboPhysical Function Score | 13.3 | — |
| Total Score | 14.1 | — |
| Bimagrumab 10 mg/kgPhysical Function Score | 15.6 | — |
| Total Score | 14.7 | — |
| Bimagrumab 30 mg/kgPhysical Function Score | 16.1 | — |
| Total Score | 16.6 | — |
| Placebo + Semaglutide 1.0 mgPhysical Function Score | 15.3 | — |
| Total Score | 17.5 | — |
| Placebo + Semaglutide 2.4 mgPhysical Function Score | 19.5 | — |
| Total Score | 21.6 | — |
| Bimagrumab 10 mg/kg + Semaglutide 1.0 mgPhysical Function Score | 18.7 | — |
| Total Score | 22.4 | — |
| Bimagrumab 10 mg/kg + Semaglutide 2.4 mgPhysical Function Score | 19.3 | — |
| Total Score | 19.2 | — |
| Bimagrumab 30 mg/kg + Semaglutide 1.0 mgPhysical Function Score | 21.6 | — |
| Total Score | 21.2 | — |
| Bimagrumab 30 mg/kg + Semaglutide 2.4 mgPhysical Function Score | 20.2 | — |
| Total Score | 23.8 | — |
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
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
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
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
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
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
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
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
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
- Nature medicine2026 Mar (month)PMID41772149doi:10.1038/s41591-026-04204-0via clinicaltrials gov reference derived + pubmed nct search
- Journal of cachexia, sarcopenia and muscle2025 Apr (month)PMID40230053doi:10.1002/jcsm.13811via clinicaltrials gov reference derived + pubmed nct search
Provenance
Sources
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.