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

Phase
Recruitment status
Participants
Lead sponsor
Start date
Number of sites

Summary
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).
Short title
Extension Trial to Evaluate the Long-term Efficacy, Safety, and Tolerability of Maridebart Cafraglutide (MARITIME-2-EXTENSION)
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 With Type 2 Diabetes Mellitus

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design

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

    Timeframe: 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)

    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 Hemoglobin A1c

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

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

    Timeframe: 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

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

  8. Percent Change from Baseline in Body Weight

    Timeframe: Baseline of current trial to Week 48

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

    Timeframe: Week 48 of current trial

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

    Timeframe: Week 48 of current trial

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

    Timeframe: 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

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

  13. Change from Baseline in HbA1c

    Timeframe: Week 48 of current trial

Sources for outcomes

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

  • 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.

  • 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).

Sources for eligibility

  • Gilbert Center for Family MedicineGilbert, United StatesRecruiting
  • San Fernando Valley Health InstituteCanoga Park, United StatesRecruiting
  • Core Healthcare GroupCerritos, United StatesRecruiting
  • Velocity Clinical Research Chula VistaLa Mesa, United StatesRecruiting
  • Paradigm Clinical ResearchModesto, United StatesRecruiting
  • Empire Clinical ResearchPomona, United StatesRecruiting
  • San Marcus Research Clinic IncMiami, United StatesRecruiting
  • Optimus U CorporationMiami, United StatesRecruiting
  • Indago Research and Health CenterMiami Lakes, United StatesRecruiting
  • Florida Institute for Clinical ResearchOrlando, United StatesRecruiting
  • Encore Medical Research of Weston LLCWeston, United StatesRecruiting
  • Conquest Research - Winter ParkWinter Park, United StatesRecruiting
  • Endeavor HealthSkokie, United StatesRecruiting
  • Iowa Diabetes ResearchWest Des Moines, United StatesRecruiting
  • JCCT- Juno Northwest HoustonLenexa, United StatesRecruiting
  • Alliance for Multispecialty Research NewtonNewton, United StatesRecruiting
  • Alliance for Multispecialty Research LLCWichita, United StatesRecruiting
  • Ima Clinical Research- MonroeMonroe, United StatesRecruiting
  • Annapolis Internal Medicine, LLCAnnapolis, United StatesRecruiting
  • Alliance for Multispecialty Research - Kansas CityKansas City, United StatesRecruiting
  • Palm Research Center IncLas Vegas, United StatesRecruiting
  • Premier ResearchTrenton, United StatesRecruiting
  • West Clinical ResearchMorehead City, United StatesRecruiting
  • Velocity Clinical Research - CincinnatiCincinnati, United StatesRecruiting
  • Velocity Clinical Research - SpringdaleCincinnati, United StatesRecruiting

And 20 more, listed on the interactive page.

Sources for sites

  • 2025
  • 2025-524788-19-00
  • U1111-1332-0531
Sources for references

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (2)