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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 99 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how well maridebart cafraglutide works over time, how safe it is, and how well people handle its side effects. It is for people with obesity or overweight who finished the earlier study and meet the rules to continue.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form and agree to follow the study rules.
  • Have finished the earlier study.
  • Have completed the week 72 visit in that study.
  • Did not permanently stop the study treatment in the earlier study.
  • Be assigned to a treatment group within 7 days of the earlier study’s week 72 visit.
  • Use the birth control required by the study during treatment and for 16 weeks after the last dose.

Who can't join

  • Plan to have weight-loss surgery, a weight-loss procedure using a scope or device, or other major surgery during the study. Minor surgery may be allowed by the study doctor.
  • Have a body mass index (BMI), a measure based on height and weight, of 18.5 or less; have a known sensitivity to a study product or ingredient; or have had damage to the eye’s nerve from poor blood flow.
  • Had cancer diagnosed during the earlier study. Exceptions are certain skin cancers other than melanoma, or early breast, cervical, or prostate cancers that have not spread, treated with the aim of curing them.
  • During the earlier study, were found to have MEN2, a condition that causes tumors in glands, or a parent, sibling, or child with medullary thyroid cancer, a type of thyroid cancer.
  • At the week 72 visit, have a score of 15 or higher on the PHQ-9 depression survey, or report suicidal thoughts with intent to act or any suicidal behavior on the study’s suicide-risk survey.
  • Are unlikely to finish the required study steps or follow its rules, or have another health condition that the study doctor thinks would make participation unsafe. This includes drug or alcohol abuse and eating disorders.
  • Are pregnant or breastfeeding, or plan to become pregnant or breastfeed during treatment or within 16 weeks after the last dose.
  • Work at the study site and are directly involved in the study, or are the spouse, parent, child, or sibling of someone who does.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (71)

AL

CA

CT

FL

GA

HI

ID

IL

KS

KY

LA

MI

MO

MS

NC

NV

NY

OH

OK

PA

RI

SC

TN

TX

UT

VA

WI