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ObesityPhase 3NCT07684144

Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)

A Phase 3 study testing Maridebart Cafraglutide in people with Obesity and Overweight, run by Amgen at 45 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Obesity, Overweight, Diabetes Mellitus, Type 2
What is being tested?
Maridebart Cafraglutide
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
950 participants
Where
45 sitesin 5 countries
Study dates
29 Jul 2026to 19 Mar 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 18Show fewer
  • 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).

Trial locations and contacts

45 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Amgen Call Center contact

866-572-6436

medinfo@amgen.com

45 sites in 5 countries

United States31 sites, 31 recruiting

  • Annapolis Internal Medicine, LLC

    Annapolis, Maryland, 21401

    Recruiting

  • Elligo Clinical Research Center

    Austin, Texas, 78704

    Recruiting

  • Johnson County Clinical Trials Juno Bellaire

    Bellaire, Texas, 77401

    Recruiting

  • Manassas Clinical Research Center Inc

    Burke, Virginia, 22015

    Recruiting

  • San Fernando Valley Health Institute

    Canoga Park, California, 91304

    Recruiting

  • Core Healthcare Group

    Cerritos, California, 90703

    Recruiting

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio, 45242

    Recruiting

  • Velocity Clinical Research - Springdale

    Cincinnati, Ohio, 45246

    Recruiting

  • Osvaldo A Brusco MD PA

    Corpus Christi, Texas, 78414

    Recruiting

  • Soma Clinical Trials, LLC

    Denison, Texas, 75020

    Recruiting

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island, 02818

    Recruiting

  • Gilbert Center for Family Medicine

    Gilbert, Arizona, 85296

    Recruiting

  • Alliance for Multispecialty Research - Kansas City

    Kansas City, Missouri, 64114

    Recruiting

  • Velocity Clinical Research Chula Vista

    La Mesa, California, 91942

    Recruiting

  • Palm Research Center Inc

    Las Vegas, Nevada, 89148

    Recruiting

  • JCCT- Juno Northwest Houston

    Lenexa, Kansas, 66219

    Recruiting

  • San Marcus Research Clinic Inc

    Miami, Florida, 33015

    Recruiting

  • Optimus U Corporation

    Miami, Florida, 33135

    Recruiting

  • Indago Research and Health Center

    Miami Lakes, Florida, 33016

    Recruiting

  • Paradigm Clinical Research

    Modesto, California, 95355

    Recruiting

  • Ima Clinical Research- Monroe

    Monroe, Louisiana, 71201

    Recruiting

  • West Clinical Research

    Morehead City, North Carolina, 28557

    Recruiting

  • Alliance for Multispecialty Research Newton

    Newton, Kansas, 67114

    Recruiting

  • Florida Institute for Clinical Research

    Orlando, Florida, 32825

    Recruiting

  • Empire Clinical Research

    Pomona, California, 91767

    Recruiting

  • Endeavor Health

    Skokie, Illinois, 60077

    Recruiting

  • Premier Research

    Trenton, New Jersey, 08611

    Recruiting

  • Iowa Diabetes Research

    West Des Moines, Iowa, 50266

    Recruiting

  • Encore Medical Research of Weston LLC

    Weston, Florida, 33331

    Recruiting

  • Alliance for Multispecialty Research LLC

    Wichita, Kansas, 67226

    Recruiting

  • Conquest Research - Winter Park

    Winter Park, Florida, 32789

    Recruiting

Other trials in United States

Japan11 sites, 11 recruiting

  • Mazda Hospital of Mazda Motor Corporation

    Aki-gun, Hiroshima, 735-8585

    Recruiting

  • Shiraiwa Medical Clinic

    Kashiwara-shi, Osaka, 582-0005

    Recruiting

  • Morizono Medical Clinic

    Kitakyusyu-shi, Fukuoka, 807-0072

    Recruiting

  • Morinaga Ueno Clinic

    Kumamoto, Kumamoto, 860-0863

    Recruiting

  • Mikannohana Clinic, Diabetes, Endocrinology and Metabolism

    Matsuyama, Ehime, 790-0034

    Recruiting

  • Yutenji Medical Clinic

    Meguro-ku, Tokyo, 153-0053

    Recruiting

  • Medical Corporation Ouitsukai Kanno Naika

    Mitaka-shi, Tokyo, 181-0013

    Recruiting

  • Nakamoto Medical Clinic

    Mito, Ibaraki, 310-0826

    Recruiting

  • Nakakinen Clinic

    Naka, Ibaraki, 311-0113

    Recruiting

  • Suruga Clinic

    Shizuoka, Shizuoka, 424-0855

    Recruiting

  • Ohishi Naika Clinic

    Tsuchiura-shi, Ibaraki, 300-0835

    Recruiting

Other trials in Japan

Canada1 site, 1 recruiting

  • Hamilton Medical Research Group

    Hamilton, Ontario, L8L 5G4

    Recruiting

Other trials in Canada

Puerto Rico1 site, 1 recruiting

  • Latin Clinical Trial Center

    San Juan, 00909

    Recruiting

Other trials in Puerto Rico

United Kingdom1 site, 1 recruiting

  • FutureMeds Birmingham

    Birmingham, B21 9RY

    Recruiting

Other trials in United Kingdom

About this study

Official title: A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight With Type 2 Diabetes Mellitus

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878).

Being tested
Maridebart Cafraglutide, Placebo
Keywords
Type 2 Diabetes Mellitus, T2DM, BMI, Obesity, Overweight, Maridebart Cafraglutide, MariTide, Chronic Weight Management, Extension, Long-Term
Medical subject headings
Obesity, Overweight, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Maridebart CafraglutideDrug

    Also called AMG 133, MariTide

    Administered subcutaneously.

  • PlaceboDrug

    Administered subcutaneously.

Study groups in NCT07684144
Study groupRoleWhat they receive
Maridebart Cafraglutide Low Dose Q4WExperimentalParticipants who received low dose of maridebart cafraglutide in the parent trial (20210184 [NCT06858878]) will continue to receive low dose of maridebart cafraglutide subcutaneously (SC) once in 4 weeks (Q4W).
Receives: Drug: Maridebart Cafraglutide
Maridebart Cafraglutide Medium Dose Q4WExperimentalParticipants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC Q4W.
Receives: Drug: Maridebart Cafraglutide
Maridebart Cafraglutide Medium dose Q8WExperimentalParticipants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC once in 8 weeks (Q8W).
Receives: Drug: Maridebart Cafraglutide
Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)Placebo comparatorParticipants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
Receives: Drug: Placebo
Maridebart Cafraglutide High Dose Q4WExperimentalParticipants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q4W.
Receives: Drug: Maridebart Cafraglutide
Maridebart Cafraglutide High Dose Q8WExperimentalParticipants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q8W.
Receives: Drug: Maridebart Cafraglutide
Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)Placebo comparatorParticipants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
Receives: Drug: Placebo
Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)ExperimentalParticipants who received placebo in the parent trial will receive high dose of maridebart cafraglutide SC Q4W. Prior to initiating the assigned high dose, participants will undergo a dose-escalation phase gradually increasing doses.
Receives: Drug: Maridebart Cafraglutide
Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)ExperimentalParticipants who permanently de-escalated to very low dose of maridebart cafraglutide in the parent trial will receive low dose of maridebart cafraglutide SC Q4W.
Receives: Drug: Maridebart Cafraglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percent Change in Body Weight from Baseline of the Parent Trial (20210184)

    Measured: Baseline of parent trial (20210184) to Week 48 of current trial

  2. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Measured: Baseline of current trial up to 60 weeks

Secondary outcomes (13)

  1. Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline of the Parent Trial

    Measured: Baseline of parent trial to Week 48 of current trial

  2. Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline of the Parent Trial

    Measured: Baseline of parent trial to Week 48 of current trial

  3. Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline of the Parent Trial

    Measured: Baseline of parent trial to Week 48 of current trial

  4. Percentage of Participants Achieving ≥ 20% Reduction in Body Weight from Baseline of the Parent Trial

    Measured: Baseline of parent trial to Week 48 of current trial

  5. Change from Baseline of the Parent Trial in Hemoglobin A1c

    Measured: Baseline of parent trial to Week 48 of current trial

  6. Change from Baseline of the Parent Trial in Waist Circumference

    Measured: Baseline of parent trial to Week 48 of current trial

  7. Change from Baseline of the Parent Trial in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score

    Measured: Baseline of parent trial to Week 48 of current trial

  8. Percent Change from Baseline in Body Weight

    Measured: Baseline of current trial to Week 48

  9. Percentage of Participants with No Body Weight Gain of >3% From Baseline

    Measured: Week 48 of current trial

  10. Percentage of Participants with No Body Weight Gain of >5% From Baseline

    Measured: Week 48 of current trial

  11. Percentage of Body Weight Reduction Maintained from the Parent Trial

    Measured: Baseline of parent trial to Week 48 of current trial

  12. Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved in the Parent Trial

    Measured: Baseline of parent trial to Week 48 of current trial

  13. Change from Baseline in HbA1c

    Measured: Week 48 of current trial

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jul 2026
  2. Study start29 Jul 2026
  3. Primary completion26 Dec 2027 (estimated)
  4. Study completion19 Mar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
950 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07684144
Sponsor's protocol ID
20210182
Other IDs
2025-524788-19-00, U1111-1332-0531, 2025
Status last verified
Sep 2026
First submitted
29 Jun 2026
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Maridebart Cafraglutide in people with Obesity and Overweight, run by Amgen at 45 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 45 sites in United States, Japan, Canada, Puerto Rico, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percent Change in Body Weight from Baseline of the Parent Trial (20210184) (time frame: Baseline of parent trial (20210184) to Week 48 of current trial). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07684144.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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