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Could a Muscle-Building drug boost weight loss? new trial tests bimagrumab with semaglutide

NCT ID NCT05616013

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 08, 2026 · Last updated Jul 09, 2026 · Updated 1 time

Summary

This phase 2 study tests whether bimagrumab, a drug that blocks a protein involved in muscle loss, can help overweight or obese adults lose more weight when used alone or alongside semaglutide (the drug in Wegovy and Ozempic). The trial includes about 500 men and women aged 18 to 80. Researchers will measure changes in body weight and waist size over 48 weeks to see if the combination is safe and effective.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bimagrumab and semaglutide
What this could lead to
If successful, this could lead to a new treatment option that helps people lose more weight than current medications alone, potentially improving health outcomes for obesity.
What could go wrong
This is an early-phase trial, so the results may not confirm effectiveness or safety. Side effects from the drugs are possible, and the combination may not work better than existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

507 people

The number who actually took part.

Started

Nov 2022

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

OBESE Obesity Overweight or obesity

Contacts and locations

Locations

  • Altus Research

    Lake Worth, Florida, 33461, United States

  • Austin Health

    Heidelberg Heights, Victoria, 3081, Australia

  • Clinical Neuroscience Solutions Inc

    Jacksonville, Florida, 32256, United States

  • Cullman Clinical Trials

    Cullman, Alabama, 35055, United States

  • Emeritus Research

    Camberwell, 3124, Australia

  • Gold Coast University Hospital

    Southport, Queensland, 4215, Australia

  • Indago Research & Health Center, Inc

    Hialeah, Florida, 33012, United States

  • Lakeland Clinical Trials Waikato

    Hamilton, 3200, New Zealand

  • Middlemore Hospital

    Auckland, 2025, New Zealand

  • Monroe Biomedical Research

    Monroe, North Carolina, 28112, United States

  • Mt. Olympus Medical Research

    Sugar Land, Texas, 77479, United States

  • New Zealand Clinical Research Auckland

    Auckland, 1010, New Zealand

  • New Zealand Clinical Research Christchurch

    Christchurch, 8011, New Zealand

  • Northern Beaches Clinical Research

    Brookvale, New South Wales, 2100, Australia

  • Optimal Clinical Trials

    Auckland, 1010, New Zealand

  • P3 Research

    Newtown, Wellington Region, 6242, New Zealand

  • Pennington Biomedical Research Center

    Baton Rouge, Louisiana, 70808, United States

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207, United States

  • Royal North Shore Hospital

    Saint Leonards, New South Wales, 2065, Australia

  • SPICA Clinical

    Columbia, South Carolina, 29322, United States

  • Southern Clinical Trials Ltd

    Beckenham, Christchurch, Canterbury, 8013, New Zealand

  • Southern Clinical Trials Tasman

    Nelson, 7011, New Zealand

  • University of The Sunshine Coast Morayfield

    Morayfield, Queensland, 4506, Australia

  • University of The Sunshine Coast South Brisbane

    South Brisbane, Queensland, 4101, Australia

  • University of the Sunshine Coast Clinical Trial Centre

    Sippy Downs, Queensland, 04556, Australia

  • Weill Cornell Medical College

    New York, New York, 10021, United States

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