Long-term test of maridebart cafraglutide in people who are overweight or have obesity

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 extension study evaluating the long-term efficacy, safety, and tolerability of maridebart cafraglutide in adults with obesity or overweight who completed a prior trial. Participants will be randomized to receive maridebart cafraglutide or placebo with continued monitoring for extended outcomes beyond the original study period. The study includes adults who completed the parent trial, adhered to the protocol, and agree to contraception during treatment and for 16 weeks after the last dose. Exclusion criteria include planned obesity-related procedures, BMI ≤ 18.5, hypersensitivity to study components, history of ischemic optic neuropathy, or malignancies treated conservatively in the prior trial. Primary sponsor is Amgen, with multiple sites in Alabama recruiting eligible participants.

Why it matters

Who can join: the full rules

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).

Where it's running

• Pinnacle Research Group LLC
  Anniston, Alabama, United States Recruiting
• Alliance For Multispecialty Research - Daphne
  Daphne, Alabama, United States Recruiting
• Alliance for Multispecialty Research Mobile
  Mobile, Alabama, United States Recruiting
• Ark Clinical Research- Tustin
  Fountain Valley, California, United States Recruiting
• Long Beach Clinical Trials Services Inc
  Long Beach, California, United States Recruiting
• Ark Clinical Research- Long Beach
  Long Beach, California, United States Recruiting

+42 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Amgen Call Center
• Email: medinfo@amgen.com
• Phone: 866-572-6436

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.