Maridebart Cafraglutide for Type 2 Diabetes and Obesity

Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)

Recruiting Phase 3 Interventional Study
Obesity Overweight Diabetes Mellitus, Type 2
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 99
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
950 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for

This trial is looking for people with obesity and type 2 diabetes who have completed a previous study. Participants will take a medication to see how it works over a longer time period, while following specific rules during the trial.

Are You a Good Fit for This Trial?
Rules you out MalignancyMultiple endocrine neoplasia syndrome type 2

You may be able to join if

  • I have completed the Week 72 visit in a previous study.
  • I have signed the informed consent form.
  • I will use birth control during the trial and for 16 weeks after it ends.
  • I did not stop taking the study medication in the previous study.
  • I was randomized within 7 days of the Week 72 visit in the previous study.

You may not be able to join if

  • I have had surgery planned for obesity during the trial.
  • I have a body mass index (BMI) of 18.5 or less.
  • I am currently pregnant or breastfeeding.
  • I have a history of any malignancy diagnosed during the last study, except nonmelanoma skin cancers.
  • I have any clinically significant disorder that might risk my safety.
  • I have had thoughts of suicide or suicide behavior.
  • I am unable to complete all required procedures as judged by my doctor.
  • I have a known sensitivity to the treatment.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

The primary objective of this trial is to evaluate the long-term efficacy, safety, and tolerability of maridebart cafraglutide in participants with obesity and type 2 diabetes mellitus. Trial 20210182 is extension of trial 20210184 (NCT06858878).

Trial Locations
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Eligibility Criteria
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 perma…
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