Maridebart Cafraglutide for Obesity and Overweight

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

Recruiting Phase 3 Interventional Study
Obesity Overweight
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
3,200 (estimated)
Sponsor
Amgen · Industry
Who this trial is looking for

This trial is looking for individuals with obesity or overweight who have completed a previous trial. Participants will receive maridebart cafraglutide and be monitored for safety and effectiveness over a longer period.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have completed the parent trial 20210181.
  • I attended the week 72 visit in the parent trial.
  • I have signed an informed consent form.
  • I have not permanently discontinued the trial intervention in the parent trial.
  • I will use contraception during treatment and for 16 weeks after my last dose.

You may not be able to join if

  • I have planned surgery or device treatment for obesity during the trial.
  • My body mass index (BMI) is 18.5 or lower.
  • I have a known sensitivity to the treatment.
  • I have a history of ischemic optic neuropathy.
  • I was diagnosed with any cancer during the parent trial, except certain skin cancers.
  • I have a serious mental health concern as indicated by my health questionnaire.
  • I am currently pregnant or breastfeeding.
  • I have a history of other significant health issues that could affect my safety.

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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Answer a few quick questions to see if you may meet the eligibility requirements.

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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 or overweight. Trial 20250197 is an extension of trial 20210181 (NCT06858839).

Trial Locations
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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 …
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