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ObesityPhase 3NCT07684235

Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)

A Phase 3 study testing Maridebart cafraglutide in people with Obesity and Overweight, run by Amgen at 92 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
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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 or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839). Read more about this study

Who is it for?
Ages 18 to 99 years
Conditions the study is for
Obesity, Overweight
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
3,200 participants
Where
92 sitesin 5 countries
Study dates
23 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) 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

Who cannot join

  • 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.
Show all 15Show fewer
  • 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).

Trial locations and contacts

92 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

92 sites in 5 countries

United States71 sites, 71 recruiting

  • Pinnacle Research Group LLC

    Anniston, Alabama, 36207

    Recruiting

  • Washington Center for Weight Management and Research, Inc

    Arlington, Virginia, 22206

    Recruiting

  • Elligo Clinical Research Center

    Austin, Texas, 78704

    Recruiting

  • Velocity Clinical Research - Baton Rouge

    Baton Rouge, Louisiana, 70809

    Recruiting

  • Johnson County Clinical Trials Juno Bellaire

    Bellaire, Texas, 77401

    Recruiting

  • Velocity Clinical Research- Binghamton

    Binghamton, New York, 13905

    Recruiting

  • Pantheon Clinical Research

    Bountiful, Utah, 84010

    Recruiting

  • Flourish Research - Great Lakes Clinical Trials

    Chicago, Illinois, 60640

    Recruiting

  • Clinical Trial Investigator Clinical Research Center

    Cincinnati, Ohio, 45212

    Recruiting

  • Velocity Clinical Research - Cincinnati

    Cincinnati, Ohio, 45219

    Recruiting

  • Cedar Health Research, LLC

    Dallas, Texas, 75235

    Recruiting

  • Cedar Health Research, LLC

    Dallas, Texas, 75251

    Recruiting

  • Alliance For Multispecialty Research - Daphne

    Daphne, Alabama, 36526

    Recruiting

  • Epic Medical Research - Red Oak

    DeSoto, Texas, 75115

    Recruiting

  • Velocity Clinical Research - Providence

    East Greenwich, Rhode Island, 02818

    Recruiting

  • Great Lakes Research Institute El Paso Research

    El Paso, Texas, 79905

    Recruiting

  • Prime Health and Wellness Sky Clinical Research Network Group

    Fayette, Mississippi, 39069

    Recruiting

  • Ark Clinical Research- Tustin

    Fountain Valley, California, 92708

    Recruiting

  • Center for Advanced Research and Education

    Gainesville, Georgia, 30501

    Recruiting

  • Tribe Clinical Research LLC Dba Mountain View Clinical Research

    Greenville, South Carolina, 29607

    Recruiting

  • Accellacare of Hickory

    Hickory, North Carolina, 28602

    Recruiting

  • East-West Medical Research

    Honolulu, Hawaii, 96814

    Recruiting

  • Biopharma Informatic, LLC

    Houston, Texas, 77043

    Recruiting

  • Jacksonville Center for Clinical Research

    Jacksonville, Florida, 32216

    Recruiting

  • Clinical Neuroscience Solutions - Jacksonville

    Jacksonville, Florida, 32256

    Recruiting

  • Alliance for Multispecialty Research - Kansas City

    Kansas City, Missouri, 64114

    Recruiting

  • New Phase Research and Development

    Knoxville, Tennessee, 37909

    Recruiting

  • Accellacare US Inc., d/b/a Accellacare of Knoxville

    Knoxville, Tennessee, 37938

    Recruiting

  • Vector Clinical Trials

    Las Vegas, Nevada, 89128

    Recruiting

  • Palm Research Center Inc

    Las Vegas, Nevada, 89148

    Recruiting

  • South Florida Wellness and Clinical Research Institute

    Lauderhill, Florida, 33351

    Recruiting

  • Alliance for Multispecialty Research Layton Research Center

    Layton, Utah, 84041

    Recruiting

  • JCCT- Juno Northwest Houston

    Lenexa, Kansas, 66219

    Recruiting

  • Long Beach Clinical Trials Services Inc

    Long Beach, California, 90806

    Recruiting

  • Ark Clinical Research- Long Beach

    Long Beach, California, 90815

    Recruiting

  • Louisville Metabolic and Atherosclerosis Research Center

    Louisville, Kentucky, 40213

    Recruiting

  • Tandem Clinical Research - Marrero

    Marrero, Louisiana, 70072

    Recruiting

  • Solaris Clinical Research

    Meridian, Idaho, 83646

    Recruiting

  • Southern Endocrinology Associates PA

    Mesquite, Texas, 75149

    Recruiting

  • Optimus U Corporation

    Miami, Florida, 33135

    Recruiting

  • Research Institute of South Florida

    Miami, Florida, 33173

    Recruiting

  • Indago Research and Health Center

    Miami Lakes, Florida, 33016

    Recruiting

  • Alliance for Multispecialty Research Mobile

    Mobile, Alabama, 36608

    Recruiting

  • Catalina Research Institute

    Montclair, California, 91763

    Recruiting

  • Capital Area Research LLC

    Newport, Pennsylvania, 17074

    Recruiting

  • Health Research of Hampton Roads

    Newport News, Virginia, 23606

    Recruiting

  • Alliance for Multispecialty Research Newton

    Newton, Kansas, 67114

    Recruiting

  • Alliance for Multispecialty Research - Norman

    Norman, Oklahoma, 73069

    Recruiting

  • Renstar Medical Research

    Ocala, Florida, 34470

    Recruiting

  • Clinical Neuroscience Solutions - Orlando

    Orlando, Florida, 32801

    Recruiting

  • Combined Research Orlando Phase I IV

    Orlando, Florida, 32807

    Recruiting

  • Florida Institute for Clinical Research

    Orlando, Florida, 32825

    Recruiting

  • Great Lakes Research Institute - McAllen Research

    Pharr, Texas, 78557

    Recruiting

  • Artemis Institute for Clinical Research

    Riverside, California, 92503

    Recruiting

  • Rochester Clinical Research

    Rochester, New York, 14609

    Recruiting

  • Clinical Trials of Texas

    San Antonio, Texas, 78229

    Recruiting

  • Artemis Institute for Clinical Research

    San Diego, California, 92103

    Recruiting

  • Apex Clinical Research

    San Diego, California, 92120

    Recruiting

  • Southern California Clinical Research

    Santa Ana, California, 92701

    Recruiting

  • Carolina Research Center Inc

    Shelby, North Carolina, 28150

    Recruiting

  • Endeavor Health

    Skokie, Illinois, 60077

    Recruiting

  • Evanston Premier Healthcare Research LLC

    Skokie, Illinois, 60077

    Recruiting

  • Headlands Research - Detroit

    Southfield, Michigan, 48034

    Recruiting

  • Chrysalis Clinical Research, LLC

    St. George, Utah, 84790

    Recruiting

  • Sugar Lakes Family Practice

    Sugar Land, Texas, 77479

    Recruiting

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

    Union City, Georgia, 30291

    Recruiting

  • Diablo Clinical Research

    Walnut Creek, California, 94598

    Recruiting

  • Chase Medical Research LLC

    Waterbury, Connecticut, 06708

    Recruiting

  • Allegiance Research Specialists

    Wauwatosa, Wisconsin, 53226

    Recruiting

  • Encore Medical Research of Weston LLC

    Weston, Florida, 33331

    Recruiting

  • Selma Medical Associates

    Winchester, Virginia, 22601

    Recruiting

Other trials in United States

Australia8 sites, 8 recruiting

  • Fusion Clinical Research

    Adelaide, SAU, 5000

    Recruiting

  • Emeritus Research Sydney

    Botany, New South Wales, 2019

    Recruiting

  • Emeritus Research Camberwell

    Camberwell, Victoria, 3124

    Recruiting

  • Novatrials

    Charlestown, New South Wales, 2290

    Recruiting

  • Logan Hospital

    Meadowbrook, Queensland, 4131

    Recruiting

  • Canopy Clinical Sutherland

    Miranda, New South Wales, 2228

    Recruiting

  • Canopy Clinical Wollongong

    Miranda, New South Wales, 2228

    Recruiting

  • Canopy Clinical Altona North

    North Altona, Victoria, 3025

    Recruiting

Other trials in Australia

Japan7 sites, 7 recruiting

  • Doujin Memorial Foundation, Meiwa Hospital

    Chiyoda-ku, Tokyo, 101-0041

    Recruiting

  • Tokyo Asbo Clinic

    Chuo-ku, Tokyo, 104-0031

    Recruiting

  • Medical Corp Seikoukai New Medical Research System Clinic

    Hachioji-shi, Tokyo, 192-0046

    Recruiting

  • Medical Corporation AOT Shinagawa Strings Clinic

    Minato-ku, Tokyo, 108-0075

    Recruiting

  • Clinical Research Hospital Tokyo

    Shinjuku-ku, Tokyo, 160-0004

    Recruiting

  • Medical Corporation Hanabusakai Shinei Medical Healthcare Clinic

    Suginami-ku, Tokyo, 166-0003

    Recruiting

  • Medical Corporation Hitomikai Motomachi Takatsuka Naika Clinic

    Yokohama, Kanagawa, 231-0023

    Recruiting

Other trials in Japan

Canada3 sites, 3 recruiting

  • Ecogene-21

    Chicoutimi, Quebec, G7H 7K9

    Recruiting

  • Wharton Medical Clinic

    Hamilton, Ontario, L8L 5G8

    Recruiting

  • Curans Heart Center

    Thunder Bay, Ontario, P7B 6V4

    Recruiting

Other trials in Canada

Puerto Rico3 sites, 3 recruiting

  • Ponce Medical School Foundation Inc

    Ponce, 00716

    Recruiting

  • Puerto Rico Medical Research Inc.

    Ponce, 00717

    Recruiting

  • Latin Clinical Trial Center

    San Juan, 00909

    Recruiting

Other trials in Puerto Rico

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

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).

Conditions
Obesity, Overweight
Being tested
Maridebart cafraglutide, Placebo
Keywords
Overweight, BMI, Obesity, Maridebart cafraglutide, Chronic weight management, MariTide, Extension, Long-Term
Medical subject headings
Obesity, Overweight

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 NCT07684235
Study groupRoleWhat they receive
Maridebart Cafraglutide Low Dose Q4WExperimentalParticipants who received low dose of maridebart cafraglutide in the parent trial (20210181 [NCT06858839]) 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 8weeks (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
Maridebart Cafraglutide High Dose Q12WExperimentalParticipants 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 once in 12 weeks (Q12W).
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 (20210181)

    Measured: Baseline of parent trial (20210181) 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 (11)

  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 Waist Circumference

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

  6. 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

  7. Percent Change from Baseline in Body Weight

    Measured: Baseline of current trial to Week 48

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

    Measured: Week 48 of current trial

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

    Measured: Week 48 of current trial

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

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

  11. 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

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 start23 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
3,200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07684235
Sponsor's protocol ID
20250197
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 92 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 15 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 92 sites in United States, Australia, Japan, Canada, Puerto Rico. 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 (20210181) (time frame: Baseline of parent trial (20210181) 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 NCT07684235.

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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