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

NCT07684235
clinicaltrials.gov
Phase
Phase 3
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Recruitment status
Recruiting
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Participants
3,200
clinicaltrials.gov
Lead sponsor
Amgen
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Start date
2026-07-23
clinicaltrials.gov
Number of sites
83
clinicaltrials.gov

Summary
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).
clinicaltrials.gov
Short title
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-1-EXTENSION)
clinicaltrials.gov
Official 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
clinicaltrials.gov

Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2028-03-19
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First posted
2026-07-06
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Registry last updated
2026-08-27
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Primary completion date
2027-12-26
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Start date
2026-07-23
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Participants
3,200
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Participant count basis
Estimated
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Planned participants
3,200
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Protocol amendments
0
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Number of sites
83
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Amgen
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07684235
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ClinicalTrials.gov ID
NCT07684235
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Percent Change in Body Weight from Baseline of the Parent Trial (20210181)

    Timeframe: Baseline of parent trial (20210181) to Week 48 of current trial

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

    Timeframe: Baseline of current trial up to 60 weeks

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

    Timeframe: 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

    Timeframe: 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

    Timeframe: 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

    Timeframe: Baseline of parent trial to Week 48 of current trial

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

    Timeframe: Baseline of parent trial to Week 48 of current trial

  6. 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

    Timeframe: Baseline of parent trial to Week 48 of current trial

  7. Percent Change from Baseline in Body Weight

    Timeframe: Baseline of current trial to Week 48

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

    Timeframe: Week 48 of current trial

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

    Timeframe: Week 48 of current trial

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

    Timeframe: Baseline of parent trial to Week 48 of current trial

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

    Timeframe: Baseline of parent trial to Week 48 of current trial

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
99 Years
Healthy volunteers
No

  • 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

  • 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).
Sources for eligibility
clinicaltrials.gov

  • Pinnacle Research Group LLCAnniston, United StatesRecruiting
  • Alliance For Multispecialty Research - DaphneDaphne, United StatesRecruiting
  • Alliance for Multispecialty Research MobileMobile, United StatesRecruiting
  • Ark Clinical Research- TustinFountain Valley, United StatesRecruiting
  • Long Beach Clinical Trials Services IncLong Beach, United StatesRecruiting
  • Ark Clinical Research- Long BeachLong Beach, United StatesRecruiting
  • Catalina Research InstituteMontclair, United StatesRecruiting
  • Artemis Institute for Clinical ResearchRiverside, United StatesRecruiting
  • Apex Clinical ResearchSan Diego, United StatesRecruiting
  • Artemis Institute for Clinical ResearchSan Diego, United StatesRecruiting
  • Southern California Clinical ResearchSanta Ana, United StatesRecruiting
  • Diablo Clinical ResearchWalnut Creek, United StatesRecruiting
  • Chase Medical Research LLCWaterbury, United StatesRecruiting
  • Jacksonville Center for Clinical ResearchJacksonville, United StatesRecruiting
  • Clinical Neuroscience Solutions - JacksonvilleJacksonville, United StatesRecruiting
  • South Florida Wellness and Clinical Research InstituteMargate, United StatesRecruiting
  • Optimus U CorporationMiami, United StatesRecruiting
  • Research Institute of South FloridaMiami, United StatesRecruiting
  • Indago Research and Health CenterMiami Lakes, United StatesRecruiting
  • Renstar Medical ResearchOcala, United StatesRecruiting
  • Clinical Neuroscience Solutions - OrlandoOrlando, United StatesRecruiting
  • Combined Research Orlando Phase I IVOrlando, United StatesRecruiting
  • Florida Institute for Clinical ResearchOrlando, United StatesRecruiting
  • Encore Medical Research of Weston LLCWeston, United StatesRecruiting
  • Center for Advanced Research and EducationGainesville, United StatesRecruiting

And 58 more, listed on the interactive page.

Sources for sites
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Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)