Not yet recruitingPhase 3

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

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

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

Recruiting sites

Estimated enrollment

3,200

Study population

Obesity / overweight

Eligibility highlights

Primary endpoints

•Body Weight from Baseline of the Parent Trial (20210181)•Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07684235

Org study ID20250197

Timeline

Milestones

Study first posted2026-07-06actual

Last update posted2026-07-06actual

Study start2026-07-29estimated

Primary completion2027-12-26estimated

Study completion2028-03-19estimated

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Who this study enrolls

Obesity / overweight

Who can enroll

Minimum age18 Years

Maximum age99 Years

SexAll

Healthy volunteersNot accepted

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).

Endpoints (13)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Safety / tolerability / PK

Weight & body composition

12 endpoints

Primary/protocol endpoint

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

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline of parent trial to Week 48 of current trial

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline of parent trial to Week 48 of current trial

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline of parent trial to Week 48 of current trial

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline of parent trial to Week 48 of current trial

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline of the Parent Trial in Waist Circumference

Time frame:Baseline of parent trial to Week 48 of current trial

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline of parent trial to Week 48 of current trial

change from baseline, improvement

Secondary/protocol endpoint

Percent Change from Baseline in Body Weight

Time frame:Baseline of current trial to Week 48

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Week 48 of current trial

threshold achievement, improvement

Secondary/protocol endpoint

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

Time frame:Week 48 of current trial

threshold achievement, improvement

Secondary/protocol endpoint

Percentage of Body Weight Reduction Maintained from the Parent Trial

Time frame:Baseline of parent trial to Week 48 of current trial

descriptive

Secondary/protocol endpoint

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

Time frame:Baseline of parent trial to Week 48 of current trial

threshold achievement, improvement

Safety / tolerability / PK

1 endpoint

Primary/protocol endpoint

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

Time frame:Baseline of current trial up to 60 weeks

event count, event

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 6, 2026 snapshot.