Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07684235

RecruitingPhase 3

Sponsor: Amgen

Conditions: Obesity, Overweight

Interventions: Maridebart cafraglutide, Placebo

Countries: United States, Australia

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).

Eligibility overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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).
Locations (31)
  • Daphne, Alabama, United States
  • San Diego, California, United States
  • San Diego, California, United States
  • Walnut Creek, California, United States
  • Waterbury, Connecticut, United States
  • Miami, Florida, United States
  • Miami, Florida, United States
  • Orlando, Florida, United States
  • Orlando, Florida, United States
  • Chicago, Illinois, United States
  • Baton Rouge, Louisiana, United States
  • Southfield, Michigan, United States
  • Binghamton, New York, United States
  • Rochester, New York, United States
  • Shelby, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Cincinnati, Ohio, United States
  • Knoxville, Tennessee, United States
  • Austin, Texas, United States
  • DeSoto, Texas, United States
  • Pharr, Texas, United States
  • San Antonio, Texas, United States
  • Bountiful, Utah, United States
  • St. George, Utah, United States
  • Newport News, Virginia, United States
  • Wauwatosa, Wisconsin, United States
  • Miranda, New South Wales, Australia
  • Wollongong, New South Wales, Australia
  • Norwood, South Australia, Australia
  • Camberwell, Victoria, Australia
  • + 1 more on CT.gov