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New weight-loss drug aims for lasting results in large phase 3 trial

NCT ID NCT07684235

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 06, 2026 · Last updated Sep 04, 2026 · Updated 7 times

Summary

This phase 3 trial tests whether the drug maridebart cafraglutide (MariTide) can help people with obesity or overweight lose weight and keep it off over the long term. Participants who completed an earlier trial will receive either the drug or a placebo. The study measures weight change and monitors for side effects.

What this could mean

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

Active substance
maridebart cafraglutide (MariTide)
What this could lead to
If successful, this could provide a long-term treatment option for significant and sustained weight loss in people with obesity or overweight.
What could go wrong
This is an extension trial, so results depend on earlier findings. Weight loss may vary, and side effects are possible. Long-term safety is still being evaluated.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 3,200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Mar 2028

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 99 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: * Signed informed consent form (ICF) which includes compliance with the requirements and restrictions listed in the ICF and in this protocol. * Completed the parent trial (2010181) * Completed week 72 visit in parent trial * Did not permanently discontinue trial intervention in parent trial * Randomized within 7 Days of week 72 visit in the parent trial * Participants must use protocol-specified contraception during treatment, and for an additional 16 weeks after the last dose of trial intervention Exclusion Criteria: * Planned (during the trial) surgical, endoscopic, or device-based treatment for obesity * Body mass index ≤ 18.5 kilograms per meter square (kg/m\^2) * Participant has known sensitivity to any of the products or components to be administered during dosing * History of ischemic optic neuropathy * Any malignancy diagnosed during parent trial (20210181) except for the following treated with curative intent: nonmelanoma skin cancers, breast ductal carcinoma in situ, cervical carcinoma in situ, or prostate cancer in situ. * Newly identified (i.e., identified during 20210181) multiple endocrine neoplasia syndrome type 2 or family (first-degree relative\[s\]) history of medullary thyroid cancer. * Patient Health Questionnaire-9 (PHQ-9) score of ≥ 15 at week 72 visit from parent trial before randomization * Any suicidal ideation of category 4 or 5 OR any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS) Since Last Visit version at week 72 visit from parent trial before randomization. * Participant unlikely to be able to complete all protocol-required procedures, restrictions and requirements, in the judgment of the individual and investigator. * History or evidence of any other clinically significant disorder, condition, or disease (including, but not limited to known drug or alcohol abuse, eating disorders, and conditions identified during the parent trial) that, in the opinion of the investigator, would pose a risk to participant safety. * Currently pregnant (confirmed with positive pregnancy test) or breastfeeding or * Planning to become pregnant or breastfeed while on trial until an additional 16 weeks after the last dose of trial intervention. * Major surgical procedures planned during the trial. * Participants with minor surgical procedures (not requiring general anesthesia or deep sedation) planned during the trial may be eligible at the discretion of the investigator. * Investigative site personnel directly affiliated with the trial and/or their immediate family (ie, spouse, parent, child, or sibling, whether biological or legally adopted).

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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.

Obesity Overweight

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    87 sites in 4 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Accellacare of Hickory

    RECRUITING

    Hickory, North Carolina, 28601, United States

  • Allegiance Research Specialists

    RECRUITING

    Wauwatosa, Wisconsin, 53226, United States

  • Alliance For Multispecialty Research - Daphne

    RECRUITING

    Daphne, Alabama, 36526, United States

  • Alliance for Multispecialty Research - Kansas City

    RECRUITING

    Kansas City, Missouri, 64114, United States

  • Alliance for Multispecialty Research - Norman

    RECRUITING

    Norman, Oklahoma, 73069, United States

  • Alliance for Multispecialty Research Layton Research Center

    RECRUITING

    Layton, Utah, 84041, United States

  • Alliance for Multispecialty Research Mobile

    RECRUITING

    Mobile, Alabama, 36608, United States

  • Alliance for Multispecialty Research Newton

    RECRUITING

    Newton, Kansas, 67114, United States

  • Apex Clinical Research

    RECRUITING

    San Diego, California, 92120, United States

  • Ark Clinical Research- Long Beach

    RECRUITING

    Long Beach, California, 90815, United States

  • Ark Clinical Research- Tustin

    RECRUITING

    Fountain Valley, California, 92708, United States

  • Artemis Institute for Clinical Research

    RECRUITING

    Riverside, California, 92503, United States

  • Artemis Institute for Clinical Research

    RECRUITING

    San Diego, California, 92123, United States

  • Biopharma Informatic, LLC

    RECRUITING

    Houston, Texas, 77043, United States

  • Canopy Clinical Altona North

    RECRUITING

    North Altona, Victoria, 3025, Australia

  • Canopy Clinical Sutherland

    RECRUITING

    Miranda, New South Wales, 2228, Australia

  • Canopy Clinical Wollongong

    RECRUITING

    Wollongong, New South Wales, 2500, Australia

  • Capital Area Research LLC

    RECRUITING

    Newport, Pennsylvania, 17074, United States

  • Carolina Research Center Inc

    RECRUITING

    Shelby, North Carolina, 28150, United States

  • Catalina Research Institute

    RECRUITING

    Montclair, California, 91763, United States

  • Cedar Health Research, LLC

    RECRUITING

    Dallas, Texas, 75251, United States

  • Cedar Health Research, LLC

    RECRUITING

    Euless, Texas, 76040, United States

  • Center for Advanced Research and Education

    RECRUITING

    Gainesville, Georgia, 30501, United States

  • Chase Medical Research LLC

    RECRUITING

    Waterbury, Connecticut, 06708, United States

  • Chrysalis Clinical Research, LLC

    RECRUITING

    St. George, Utah, 84770, United States

  • Clinical Neuroscience Solutions - Jacksonville

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions - Orlando

    RECRUITING

    Orlando, Florida, 32801, United States

  • Clinical Research Hospital Tokyo

    RECRUITING

    Shinjuku-ku, Tokyo, 160-0004, Japan

  • Clinical Trial Investigator Clinical Research Center

    RECRUITING

    Cincinnati, Ohio, 45212, United States

  • Clinical Trials of Texas

    RECRUITING

    San Antonio, Texas, 78229, United States

  • Combined Research Orlando Phase I IV

    RECRUITING

    Orlando, Florida, 32807, United States

  • Diablo Clinical Research

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Doujin Memorial Foundation, Meiwa Hospital

    RECRUITING

    Chiyoda-ku, Tokyo, 101-0041, Japan

  • East-West Medical Research

    RECRUITING

    Honolulu, Hawaii, 96814, United States

  • Elligo Clinical Research Center

    RECRUITING

    Austin, Texas, 78704, United States

  • Emeritus Research Camberwell

    RECRUITING

    Camberwell, Victoria, 3124, Australia

  • Emeritus Research Sydney

    RECRUITING

    Botany, New South Wales, 2019, Australia

  • Encore Medical Research of Weston LLC

    RECRUITING

    Weston, Florida, 33331, United States

  • Endeavor Health

    RECRUITING

    Skokie, Illinois, 60077, United States

  • Epic Medical Research - Red Oak

    RECRUITING

    DeSoto, Texas, 75115, United States

  • Evanston Premier Healthcare Research LLC

    RECRUITING

    Skokie, Illinois, 60077, United States

  • Florida Institute for Clinical Research

    RECRUITING

    Orlando, Florida, 32825, United States

  • Flourish Research - Great Lakes Clinical Trials

    RECRUITING

    Chicago, Illinois, 60640, United States

  • Fusion Clinical Research

    RECRUITING

    Norwood, South Australia, 5067, Australia

  • Great Lakes Research Institute - McAllen Research

    RECRUITING

    Pharr, Texas, 78557, United States

  • Great Lakes Research Institute El Paso Research

    RECRUITING

    El Paso, Texas, 79936, United States

  • Headlands Research - Detroit

    RECRUITING

    Southfield, Michigan, 48034, United States

  • Health Research of Hampton Roads

    RECRUITING

    Newport News, Virginia, 23606, United States

  • Indago Research and Health Center

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • JCCT- Juno Northwest Houston

    RECRUITING

    Houston, Texas, 77040, United States

  • Jacksonville Center for Clinical Research

    RECRUITING

    Jacksonville, Florida, 32216, United States

  • Johnson County Clinical Trials Juno Bellaire

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Latin Clinical Trial Center

    RECRUITING

    San Juan, 00909, Puerto Rico

  • Long Beach Clinical Trials Services Inc

    RECRUITING

    Long Beach, California, 90806, United States

  • Medical Corp Seikoukai New Medical Research System Clinic

    RECRUITING

    Hachioji-shi, Tokyo, 192-0046, Japan

  • Medical Corporation AOT Shinagawa Strings Clinic

    RECRUITING

    Minato-ku, Tokyo, 108-0075, Japan

  • Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic

    RECRUITING

    Suginami-ku, Tokyo, 166-0003, Japan

  • Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic

    RECRUITING

    Yokohama, Kanagawa, 231-0023, Japan

  • Monroe Biomedical Research

    RECRUITING

    Louisville, Kentucky, 40213, United States

  • New Phase Research and Development

    RECRUITING

    Knoxville, Tennessee, 37909, United States

  • Novatrials

    RECRUITING

    Charlestown, New South Wales, 2290, Australia

  • Optimus U Corporation

    RECRUITING

    Miami, Florida, 33135, United States

  • Palm Research Center Inc

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Pantheon Clinical Research

    RECRUITING

    Bountiful, Utah, 84010, United States

  • Pinnacle Research Group LLC

    RECRUITING

    Anniston, Alabama, 36207, United States

  • Ponce Medical School Foundation Inc

    RECRUITING

    Ponce, 00716, Puerto Rico

  • Prime Health and Wellness Sky Clinical Research Network Group

    RECRUITING

    Fayette, Mississippi, 39069, United States

  • Puerto Rico Medical Research Inc.

    RECRUITING

    Ponce, 00717, Puerto Rico

  • Renstar Medical Research

    RECRUITING

    Ocala, Florida, 34470, United States

  • Research Institute of South Florida

    RECRUITING

    Miami, Florida, 33173, United States

  • Rochester Clinical Research

    RECRUITING

    Rochester, New York, 14609, United States

  • Rophe Adult and Pediatric Medicine/Sky Clinical Research Network Group

    RECRUITING

    Union City, Georgia, 30291, United States

  • Selma Medical Associates

    RECRUITING

    Winchester, Virginia, 22601, United States

  • Solaris Clinical Research

    RECRUITING

    Meridian, Idaho, 83646, United States

  • South Florida Wellness and Clinical Research Institute

    RECRUITING

    Margate, Florida, 33063, United States

  • Southern California Clinical Research

    RECRUITING

    Santa Ana, California, 92701, United States

  • Southern Endocrinology Associates PA

    RECRUITING

    Mesquite, Texas, 75149, United States

  • Sugar Lakes Family Practice

    RECRUITING

    Sugar Land, Texas, 77479, United States

  • Tandem Clinical Research - Marrero

    RECRUITING

    Marrero, Louisiana, 70072, United States

  • Tokyo Asbo Clinic

    RECRUITING

    Chuo-ku, Tokyo, 104-0031, Japan

  • Tribe Clinical Research LLC Dba Mountain View Clinical Research

    RECRUITING

    Greenville, South Carolina, 29607, United States

  • Vector Clinical Trials

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Velocity Clinical Research - Baton Rouge

    RECRUITING

    Baton Rouge, Louisiana, 70809, United States

  • Velocity Clinical Research - Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45219, United States

  • Velocity Clinical Research - Providence

    RECRUITING

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Clinical Research- Binghamton

    RECRUITING

    Binghamton, New York, 13905, United States

  • Washington Center for Weight Management and Research, Inc

    RECRUITING

    Arlington, Virginia, 22206, United States

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