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

Sponsor
Amgen
Study ID
NCT07684144
Phase
PHASE3
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Maridebart Cafraglutide — DRUG
    Administered subcutaneously.
  • Placebo — DRUG
    Administered subcutaneously.

Study Details

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).

Key Dates

First listed
Jul 6, 2026
Start date
Jul 29, 2026
Status verified
Jun 2026
Primary completion
Dec 26, 2027
Completion
Mar 19, 2028

Study Design

Enrollment
950 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Maridebart Cafraglutide Low Dose Q4W
    Participants who received low dose of maridebart cafraglutide in the parent trial (20210184 \[NCT06858878\]) will continue to receive low dose of maridebart cafraglutide subcutaneously (SC) once in 4 weeks (Q4W).
  • Experimental: Maridebart Cafraglutide Medium Dose Q4W
    Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC Q4W.
  • Experimental: Maridebart Cafraglutide Medium dose Q8W
    Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive medium dose of maridebart cafraglutide SC once in 8 weeks (Q8W).
  • Placebo Comparator: Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)
    Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
  • Experimental: Maridebart Cafraglutide High Dose Q4W
    Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q4W.
  • Experimental: Maridebart Cafraglutide High Dose Q8W
    Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive high dose of maridebart cafraglutide SC Q8W.
  • Placebo Comparator: Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)
    Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.
  • Experimental: Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)
    Participants who received placebo in the parent trial will receive high dose of maridebart cafraglutide SC Q4W. Prior to initiating the assigned high dose, participants will undergo a dose-escalation phase gradually increasing doses.
  • Experimental: Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)
    Participants who permanently de-escalated to very low dose of maridebart cafraglutide in the parent trial will receive low dose of maridebart cafraglutide SC Q4W.

Primary Outcome Measure

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 ]

Central Contacts

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