Current partner codePEPTIDESDE
NCT07684235·Phase 3·INTERVENTIONAL

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

Status

Not yet recruiting

Phase

Phase 3

Enrollment

3,200

Locations

0

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

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).

Interventions

Treatment arms and agents.

DRUG

Maridebart cafraglutide

Administered subcutaneously

DRUG

Placebo

Administered subcutaneously.

Timeline

From registration to results.

  1. First posted

    Jul 6, 2026

  2. Study start

    Jul 29, 2026

  3. Primary completion

    Dec 26, 2027

  4. Study completion

    Mar 19, 2028

  5. Results posted

    Not reported

  6. Registry updated

    Jul 6, 2026

Outcomes

What the study measures.

Primary outcomes

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

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

Time frame · Baseline of current trial up to 60 weeks

Secondary outcomes

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

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

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

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 of the Parent Trial in Waist Circumference

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

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

Percent Change from Baseline in Body Weight

Time frame · Baseline of current trial to Week 48

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

Time frame · Week 48 of current trial

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

Time frame · Week 48 of current trial

Percentage of Body Weight Reduction Maintained from the Parent Trial

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

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
99 Years
Sex
ALL
Healthy volunteers
No

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).

Study locations

0 registered sites.

No country data reported. Showing up to 24 locations stored in the fast local snapshot.

No study locations reported.

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Maridebart cafraglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.