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NCT Number: NCT07684144

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

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Maridebart cafraglutide

Drug

Administered subcutaneously.

Other names: AMG 133, MariTide

Placebo

Drug

Administered subcutaneously.

Primary outcomes

  1. Percent Change in Body Weight from Baseline of the Parent Trial (20210184)

    Time frame: Baseline of parent trial (20210184) to Week 48 of current trial

  2. Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

    Time frame: Baseline of current trial up to 60 weeks

Secondary outcomes

  1. Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline of the Parent Trial

    Time frame: Baseline of parent trial to Week 48 of current trial

  2. Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline of the Parent Trial

    Time frame: Baseline of parent trial to Week 48 of current trial

  3. Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline of the Parent Trial

    Time frame: Baseline of parent trial to Week 48 of current trial

  4. Percentage of Participants Achieving ≥ 20% Reduction in Body Weight from Baseline of the Parent Trial

    Time frame: Baseline of parent trial to Week 48 of current trial

  5. Change from Baseline of the Parent Trial in Hemoglobin A1c

    Time frame: Baseline of parent trial to Week 48 of current trial

  6. Change from Baseline of the Parent Trial in Waist Circumference

    Time frame: Baseline of parent trial to Week 48 of current trial

  7. Change from Baseline of the Parent Trial in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score

    Time frame: Baseline of parent trial to Week 48 of current trial

  8. Percent Change from Baseline in Body Weight

    Time frame: Baseline of current trial to Week 48

  9. Percentage of Participants with No Body Weight Gain of >3% From Baseline

    Time frame: Week 48 of current trial

  10. Percentage of Participants with No Body Weight Gain of >5% From Baseline

    Time frame: Week 48 of current trial

  11. Percentage of Body Weight Reduction Maintained from the Parent Trial

    Time frame: Baseline of parent trial to Week 48 of current trial

  12. Percentage of Participants Maintaining ≥ 80% of the Body Weight Reduction Achieved in the Parent Trial

    Time frame: Baseline of parent trial to Week 48 of current trial

  13. Change from Baseline in HbA1c

    Time frame: Week 48 of current trial

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Participants With Obesity or Overweight With Type 2 Diabetes Mellitus

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jul 6, 2026
Registry last updated
Jul 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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