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Can a Muscle-Saving drug boost weight loss?

NCT ID NCT06445075

Disease control Sponsor: Scholar Rock, Inc. 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 study tested whether adding apitegromab (a drug that blocks a muscle-weakening protein) to tirzepatide (a GLP-1 weight-loss drug) helps overweight and obese adults lose fat while keeping lean muscle. 102 participants received either the combination or placebo over 24 weeks. The main goal was to see changes in total lean body mass and body weight.

What this could mean

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

Active substance
apitegromab (a drug that blocks myostatin activation, given by IV infusion every 4 weeks) plus tirzepatide (a GLP-1 receptor agonist)
What this could lead to
If successful, this combination could help people lose fat while preserving muscle, improving body composition and metabolic health.
What could go wrong
This is an early phase 2 trial with only 102 participants, so results may not apply to everyone. The drug is given by IV, which is less convenient than injections used for other weight-loss medications.

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

102 people

The number who actually took part.

Started

May 2024

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 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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.

Inclusion Criteria * Able to comprehend the informed consent process and provide written informed consent prior to study enrollment and the conduct of any study-related assessments to study enrollment and the conduct of any study-related assessments * Male or female, age ≥ 18 and ≤ 65 years at the time of informed consent * Stable body weight (±5 kg) within 90 days of Screening * At Screening, a BMI of: 1. ≥30.0 kg/m2 to ≤45.0 kg/m2 or 2. ≥27.0 kg/m2 to \<30.0 kg/m2 with the presence of 1 or more weight-related comorbid condition(s). Note: See exclusion criteria for specific organ class disease parameters Exclusion Criteria: * History of or active cardiovascular, neurovascular, peripheral vascular, pulmonary, hepatic, pancreatic, neuromuscular, and/or psychiatric disease * Active malignancy, other than local subcutaneous squamous cell and basal cell carcinomas * History of immunosuppressive, chemotherapeutic, or radiation treatment within 12 months prior to Screening * History of Type 1 diabetes or active Type 2 diabetes (T2D). If there was a history of T2D and it resolved, then the resolution must have occurred \>12 months prior to Screening. Prediabetes managed with nonpharmacologic approaches (exercise and diet) is not an exclusion

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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.

Overweight and obesity

Contacts and locations

Locations

  • AdventHealth Translational Research Institute

    Orlando, Florida, 32804, United States

  • Alliance for Multispecialty Research, LLC

    Norman, Oklahoma, 73069, United States

  • Apex Mobile Clinical Research

    Bellaire, Texas, 77401, United States

  • Clinical Trials of Texas, LLC dba Flourish Research

    San Antonio, Texas, 78229, United States

  • Great Lakes Clinical Trials, LLC d/b/a Flourish Research

    Chicago, Illinois, 60640, United States

  • ProSciento CRU

    Chula Vista, California, 91911, United States

  • Tandem Clinical Research GI, LLC

    Marrero, Louisiana, 70072, United States

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