Bimagrumab plus semaglutide alone or in combination for the treatment of obesity: a randomized phase 2 trial.

Heymsfield SB, Aronne LJ, Montgomery P, Klickstein LB, Coleman LA, Dole K, Mindeholm L, Spruill S, Li X, Attie KM

Nature medicine2 Mar 2026Cited by 46 (Europe PMC)

PMID41772149PMCIDPMC13004672DOI10.1038/s41591-026-04204-0PepBankPUB-41772149

Summary

Bimagrumab is an investigational antibody targeting type II activin receptors, intended to reduce total body and visceral fat mass and promote muscle growth. In this double-blind, placebo-controlled phase 2, trial, 507 adults with obesity (body mass index ≥30 kg m^-² or ≥27 kg m^-² with at least one obesity-associated complication (excluding diabetes) were randomized to nine groups (1:1:1:1:1:1:1:1:1 ratio) to receive treatment for 48 weeks: placebo, bimagrumab (10 mg kg^-1 or 30 mg kg^-1 intravenously every 12 weeks), semaglutide (1.0 mg or 2.4 mg subcutaneously once a week) and combinations thereof. An open-label treatment extension to week 72 followed. Randomization was stratified by sex across the treatment groups. The primary and secondary endpoints were absolute change from baseline in body weight at week 48 and week 72, respectively. 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) (all P < 0.001 versus placebo). Continued improvements were observed through week 72. Common adverse events for bimagrumab included muscle spasms, diarrhea and acne, and semaglutide was associated with nausea, diarrhea, constipation and fatigue. Bimagrumab plus semaglutide resulted in substantial reductions in body weight, and safety was consistent with the known safety profiles of both drugs. ClinicalTrials.gov identifier: NCT05616013 .

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

5 results from studies that gave the peptide. 5 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with obesity, semaglutide 2.4 mg reduced body weight by a least squares mean of 14.2 kg at week 48, versus 3.3 kg with placebo.
In plain wordsIn adults with obesity, semaglutide 2.4 mg lowered body weight more than placebo after 48 weeks.
Peptide
Semaglutide
Outcome
DecreaseBody weight change at week 48, semaglutide 2.4 mg
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Studied dose
2.4 mg once a week · subcutaneous · 48 weeksAs given in this study (human).
Measurements
body weight change
−14.2 kg
semaglutide 2.4 mg
body weight change
−3.3 kg
placebo
Source sentences
Summary
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) (all P < 0.001 versus placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled phase 2, trial, 507 adults with obesity (body mass index ≥30 kg m^-² or ≥27 kg m^-² with at least one obesity-associated complication (excluding diabetes)
Show in the study text Report a problemFND-4177214901
02HumanRandomized controlled trialSafety outcome
In adults with obesity, nausea was among the common adverse events with semaglutide.
In plain wordsIn adults with obesity, nausea was a common side effect of semaglutide.
Peptide
Semaglutide
Outcome
Not applicableNausea with semaglutide
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.0 mg or 2.4 mg once a week · subcutaneous · 48 weeksAs given in this study (human).
Source sentences
Summary
semaglutide was associated with nausea, diarrhea, constipation and fatigue.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled phase 2, trial, 507 adults with obesity (body mass index ≥30 kg m^-² or ≥27 kg m^-² with at least one obesity-associated complication (excluding diabetes)
Show in the study text Report a problemFND-4177214903
03HumanRandomized controlled trialSafety outcome
In adults with obesity, diarrhea was among the common adverse events with semaglutide.
In plain wordsIn adults with obesity, diarrhea was a common side effect of semaglutide.
Peptide
Semaglutide
Outcome
Not applicableDiarrhea with semaglutide
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.0 mg or 2.4 mg once a week · subcutaneous · 48 weeksAs given in this study (human).
Source sentences
Summary
semaglutide was associated with nausea, diarrhea, constipation and fatigue.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled phase 2, trial, 507 adults with obesity (body mass index ≥30 kg m^-² or ≥27 kg m^-² with at least one obesity-associated complication (excluding diabetes)
Show in the study text Report a problemFND-4177214904
04HumanRandomized controlled trialSafety outcome
In adults with obesity, constipation was among the common adverse events with semaglutide.
In plain wordsIn adults with obesity, constipation was a common side effect of semaglutide.
Peptide
Semaglutide
Outcome
Not applicableConstipation with semaglutide
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
1.0 mg or 2.4 mg once a week · subcutaneous · 48 weeksAs given in this study (human).
Source sentences
Summary
semaglutide was associated with nausea, diarrhea, constipation and fatigue.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled phase 2, trial, 507 adults with obesity (body mass index ≥30 kg m^-² or ≥27 kg m^-² with at least one obesity-associated complication (excluding diabetes)
Show in the study text Report a problemFND-4177214905
05HumanRandomized controlled trialSafety outcome
In adults with obesity, fatigue was among the common adverse events with semaglutide.
In plain wordsIn adults with obesity, fatigue was a common side effect of semaglutide.
Peptide
Semaglutide
Outcome
Not applicableFatigue with semaglutide
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
1.0 mg or 2.4 mg once a week · subcutaneous · 48 weeksAs given in this study (human).
Source sentences
Summary
semaglutide was associated with nausea, diarrhea, constipation and fatigue.
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled phase 2, trial, 507 adults with obesity (body mass index ≥30 kg m^-² or ≥27 kg m^-² with at least one obesity-associated complication (excluding diabetes)
Show in the study text Report a problemFND-4177214906

Studies that did not test the peptide alone1

In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. These results are not evidence about taking Semaglutide.

06HumanNot a test of Semaglutide aloneRandomized controlled trialEfficacy outcome
In adults with obesity, the combination of bimagrumab 30 mg/kg and semaglutide 2.4 mg reduced body weight by a least squares mean of 17.8 kg at week 48, versus 3.3 kg with placebo.
In plain wordsIn adults with obesity, bimagrumab plus semaglutide lowered body weight more than placebo after 48 weeks. The result is for the combination, not semaglutide alone.
Peptide
Semaglutide
Outcome
DecreaseBody weight change at week 48, bimagrumab 30 mg/kg plus semaglutide 2.4 mg
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Body weight · Metabolic and weight
Measurements
body weight change
−17.8 kg
bimagrumab 30 mg/kg plus semaglutide 2.4 mg
body weight change
−3.3 kg
placebo
Source sentences
Summary
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) (all P < 0.001 versus placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
In this double-blind, placebo-controlled phase 2, trial, 507 adults with obesity (body mass index ≥30 kg m^-² or ≥27 kg m^-² with at least one obesity-associated complication (excluding diabetes)
In this study, Semaglutide was a lab tool or a carrier, part of a mix, or the subject of a lab method. This result is not evidence about taking Semaglutide.
Show in the study text Report a problemFND-4177214902

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2Results postedNCT05616013

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

Eli Lilly and Companyn = 50716 Nov 2022 to 14 Jun 2025

Obesity · Obese · Overweight or Obesity

Trial page ClinicalTrials.govUpdated 8 Jul 2026

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
11 Oct 2026, 00:04 UTC
Study results updated
Version 1
9 Oct 2026, 03:06 UTC
First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

MeSH terms

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