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New drug shows promise for sustained weight loss in type 2 diabetes

NCT ID NCT07684144

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests a drug called maridebart cafraglutide (MariTide) in people who are overweight or obese and also have type 2 diabetes. The goal is to see if the drug can help with long-term weight loss and blood sugar control, and to check its safety over time. Participants receive either the drug or a placebo as an injection under the skin.

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 new long-term treatment option for weight loss and blood sugar control in people with obesity and type 2 diabetes.
What could go wrong
This is an extension trial, so results depend on earlier findings. Side effects may occur, and the drug may not work for everyone or may lose effectiveness over time.

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 950 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) indicating compliance with the requirements and restrictions listed in the ICF and this protocol. * Participants completing Study 20210184 must meet the following criteria: * Completed the Week 72 visit in Study 20210184. * Did not permanently discontinue the investigational product in the parent trial (20210184). * Randomized within 7 days of week 72 visit in the parent trial. * Participants must use protocol-specified contraception during treatment and for 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 (BMI) ≤ 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 the parent trial, except for the following treated with curative intent: * Nonmelanoma skin cancers * Breast ductal carcinoma in situ * Cervical carcinoma in situ * Prostate cancer in situ * Newly identified (during the parent trial) multiple endocrine neoplasia syndrome type 2, or family history (first-degree relative\[s\]) history of medullary thyroid carcinoma (MTC). * Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at the Week 72 visit from the parent trial (20210184) before randomization. * Any suicidal ideation (category 4 or 5) or any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS), Since Last Visit version, at the Week 72 visit from the 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, 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 type 2 diabetes mellitus

As listed by the trial registrant

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

Diabetes mellitus, type 2 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

    37 sites in 3 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

  • Alliance for Multispecialty Research - Kansas City

    RECRUITING

    Kansas City, Missouri, 64114, United States

  • Alliance for Multispecialty Research LLC

    RECRUITING

    Wichita, Kansas, 67226, United States

  • Alliance for Multispecialty Research Newton

    RECRUITING

    Newton, Kansas, 67114, United States

  • Conquest Research - Winter Park

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Core Healthcare Group

    RECRUITING

    Cerritos, California, 90703, United States

  • Elligo Clinical Research Center

    RECRUITING

    Austin, Texas, 78704, United States

  • Empire Clinical Research

    RECRUITING

    Pomona, California, 91767, United States

  • Encore Medical Research of Weston LLC

    RECRUITING

    Weston, Florida, 33331, United States

  • Florida Institute for Clinical Research

    RECRUITING

    Orlando, Florida, 32825, United States

  • Gilbert Center for Family Medicine

    RECRUITING

    Gilbert, Arizona, 85296, United States

  • Indago Research and Health Center

    RECRUITING

    Miami Lakes, Florida, 33016, United States

  • Iowa Diabetes Research

    RECRUITING

    West Des Moines, Iowa, 50266, United States

  • JCCT- Juno Northwest Houston

    RECRUITING

    Houston, Texas, 77040, United States

  • Johnson County Clinical Trials Juno Bellaire

    RECRUITING

    Bellaire, Texas, 77401, United States

  • Latin Clinical Trial Center

    RECRUITING

    San Juan, 00909, Puerto Rico

  • Manassas Clinical Research Center Inc

    RECRUITING

    Manassas, Virginia, 20110, United States

  • Medical Corporation Ouitsukai Kanno Naika

    RECRUITING

    Mitaka-shi, Tokyo, 181-0013, Japan

  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

    RECRUITING

    Matsuyama, Ehime, 790-0034, Japan

  • Morinaga Ueno Clinic

    RECRUITING

    Kumamoto, Kumamoto, 860-0863, Japan

  • Morizono Medical Clinic

    RECRUITING

    Kitakyusyu-shi, Fukuoka, 807-0072, Japan

  • Nakakinen Clinic

    RECRUITING

    Naka, Ibaraki, 311-0113, Japan

  • Nakamoto Medical Clinic

    RECRUITING

    Mito, Ibaraki, 310-0826, Japan

  • Ohishi Naika Clinic

    RECRUITING

    Tsuchiura-shi, Ibaraki, 300-0835, Japan

  • Optimus U Corporation

    RECRUITING

    Miami, Florida, 33135, United States

  • Osvaldo A Brusco MD PA

    RECRUITING

    Corpus Christi, Texas, 78414, United States

  • Palm Research Center Inc

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Premier Research

    RECRUITING

    Trenton, New Jersey, 08611, United States

  • San Fernando Valley Health Institute

    RECRUITING

    Canoga Park, California, 91304, United States

  • San Marcus Research Clinic Inc

    RECRUITING

    Miami Lakes, Florida, 33014, United States

  • Shiraiwa Medical Clinic

    RECRUITING

    Kashiwara-shi, Osaka, 582-0005, Japan

  • Soma Clinical Trials, LLC

    RECRUITING

    Denison, Texas, 75020, United States

  • Suruga Clinic

    RECRUITING

    Shizuoka, Shizuoka, 424-0855, Japan

  • Velocity Clinical Research - Cincinnati

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Velocity Clinical Research - Providence

    RECRUITING

    East Greenwich, Rhode Island, 02818, United States

  • Velocity Clinical Research - Springdale

    RECRUITING

    Cincinnati, Ohio, 45246, United States

  • Velocity Clinical Research Chula Vista

    RECRUITING

    Chula Vista, California, 91911, United States

  • West Clinical Research

    RECRUITING

    Morehead City, North Carolina, 28557, United States

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