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

Conditions

• Obesity
• Overweight

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

Key Dates

First listed

Jul 6, 2026

Start date

Jul 23, 2026

Status verified

Jul 2026

Primary completion

Dec 26, 2027

Completion

Mar 19, 2028

Study Design

Enrollment

3,200 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 (20210181 \[NCT06858839\]) 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 8weeks (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.
• Experimental: Maridebart Cafraglutide High Dose Q12W
  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 once in 12 weeks (Q12W).
• 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 (20210181) [ Time Frame: Baseline of parent trial (20210181) to Week 48 of current trial ]

Central Contacts

• Amgen Call Center
  866-572-6436
  [email protected]

Locations (26)

Find similar trials in Daphne, AL

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