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New drug combo aims to supercharge weight loss in obesity trial

NCT ID NCT06643728

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 2 study tests two drugs, bimagrumab and tirzepatide, alone or together, to see if they help adults with obesity or overweight lose weight safely. About 252 participants without type 2 diabetes will take the drugs or a placebo for up to 70 weeks. The main goal is to measure how much body weight and fat they lose.

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 tirzepatide (drugs)
What this could lead to
If successful, this could lead to a new combination treatment that helps people with obesity lose more weight and body fat than current options.
What could go wrong
This is an early phase 2 trial with only 252 participants, so results may not apply to everyone. The drugs may cause side effects or not work better than placebo.

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

252 people

The number who actually took part.

Started

Oct 2024

Expected to finish

Jan 2027

An estimate. End dates often move.

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 75 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.

Inclusion Criteria: * Have a BMI of * ≥30 kilograms per square meter (kg/m2) or * ≥27 kg/m2 and \<30 kg/m2, with at least one of the following weight-related comorbidities: * Hypertension * Dyslipidemia * Cardiovascular disease * Obstructive sleep apnea * Have had a stable body weight for the 3 months prior to randomization (\<5% body weight gain and/or loss) Exclusion Criteria: * Have a prior or planned surgical treatment for obesity * Have at least one laboratory value suggestive of diabetes during screening * Use of metformin, or any other glucose-lowering medications * Have Type 1 Diabetes, latent autoimmune diabetes, been diagnosed with any form of diabetes mellitus except for a prior diagnosis of gestational diabetes mellitus, or history of ketoacidosis or hyperosmolar coma * Have poorly controlled hypertension * Have any of the following cardiovascular conditions within 3 months prior to screening: * acute myocardial infarction * cerebrovascular accident (stroke) * unstable angina, or * hospitalization due to congestive heart failure * Have ongoing or a history of frequent intermittent or chronic tachyarrhythmia syndromes * Have ongoing or a history of bradyarrhythmias other than sinus bradycardia * Have a history of New York Heart Association (NYHA) Functional Classification III or IV congestive heart failure * Have a history of symptomatic gallbladder disease within the past 2 years * Have signs and symptoms of any liver disease * Have a disease or condition known to cause gastrointestinal malabsorption or a known clinically significant gastric emptying abnormality * Have a history of acute or chronic pancreatitis * Have renal impairment, measured as estimated glomerular filtration rate \<30 mL/minute/1.73 m2 * Currently taking or have taken medications that may cause significant weight gain or promote weight loss within 3 months prior to screening

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Altus Research

    Lake Worth, Florida, 33461, United States

  • Central Research Associates

    Birmingham, Alabama, 35205, United States

  • Clinical Neuroscience Solutions, Inc. dba CNS Healthcare

    Jacksonville, Florida, 32256, United States

  • Diablo Clinical Research, Inc.

    Walnut Creek, California, 94598, United States

  • East-West Medical Research Institute

    Honolulu, Hawaii, 96814, United States

  • Eastside Research Associates

    Redmond, Washington, 98052, United States

  • Great Lakes Clinical Trials - Ravenswood

    Chicago, Illinois, 60640, United States

  • Keystone Clinical Studies

    Plymouth Meeting, Pennsylvania, 19462, United States

  • Pinnacle Research Group, LLC

    Anniston, Alabama, 36207, United States

  • Rainier Clinical Research Center

    Renton, Washington, 98057, United States

  • SKY Integrative Medical Center/SKYCRNG

    Ridgeland, Mississippi, 39157, United States

  • Suncoast Research Group

    Miami, Florida, 33135, United States

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