Long-term test of maridebart cafraglutide for obesity and type 2 diabetes

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 trial evaluating the long-term efficacy, safety, and tolerability of maridebart cafraglutide in adults with obesity and type 2 diabetes. Participants are those who completed the prior study and met specific criteria, continuing or resuming treatment with either maridebart cafraglutide or placebo. The study compares long-term outcomes, including weight and metabolic parameters, while monitoring adverse events. Locations include sites in Arizona and California. Lead sponsor is Amgen, with no listed collaborators.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signed informed consent form (ICF) indicating compliance with the requirements and restrictions listed in the ICF and this protocol.
* Participants completing Study 20210184 must meet the following criteria:

  * Completed the Week 72 visit in Study 20210184.
  * Did not permanently discontinue the investigational product in the parent trial (20210184).
  * Randomized within 7 days of week 72 visit in the parent trial.
* Participants must use protocol-specified contraception during treatment and for 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 (BMI) ≤ 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 the parent trial, except for the following treated with curative intent:

  * Nonmelanoma skin cancers
  * Breast ductal carcinoma in situ
  * Cervical carcinoma in situ
  * Prostate cancer in situ
* Newly identified (during the parent trial) multiple endocrine neoplasia syndrome type 2, or family history (first-degree relative\[s\]) history of medullary thyroid carcinoma (MTC).
* Patient Health Questionnaire-9 (PHQ-9) score ≥ 15 at the Week 72 visit from the parent trial (20210184) before randomization.
* Any suicidal ideation (category 4 or 5) or any suicidal behavior on the Columbia-Suicide Severity Rating Scale (C-SSRS), Since Last Visit version, at the Week 72 visit from the 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, 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

• Gilbert Center for Family Medicine
  Gilbert, Arizona, United States Recruiting
• San Fernando Valley Health Institute
  Canoga Park, California, United States Recruiting
• Core Healthcare Group
  Cerritos, California, United States Recruiting
• Velocity Clinical Research Chula Vista
  La Mesa, California, United States Recruiting
• Paradigm Clinical Research
  Modesto, California, United States Recruiting
• Empire Clinical Research
  Pomona, California, United States Recruiting

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.