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

Amgen

Status and phase: Enrolling; Phase 3

Conditions: Overweight; Obesity

Treatments: Drug: Maridebart cafraglutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07684235

20250197

Details and patient eligibility

About

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).

Enrollment: 3,200 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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3,200 participants in 10 patient groups, including a placebo group

Maridebart Cafraglutide Low Dose Q4W

Experimental group

Description:

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).

Treatment:

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Medium Dose Q4W

Experimental group

Description:

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.

Treatment:

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Medium Dose Q8W

Experimental group

Description:

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).

Treatment:

Drug: Maridebart cafraglutide

Placebo Q4W (Received Medium Dose Maridebart Cafraglutide in Parent Trial)

Placebo Comparator group

Description:

Participants who received medium dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.

Treatment:

Drug: Placebo

Maridebart Cafraglutide High Dose Q4W

Experimental group

Description:

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.

Treatment:

Drug: Maridebart cafraglutide

Maridebart Cafraglutide High Dose Q8W

Experimental group

Description:

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.

Treatment:

Drug: Maridebart cafraglutide

Maridebart Cafraglutide High Dose Q12W

Experimental group

Description:

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).

Treatment:

Drug: Maridebart cafraglutide

Placebo Q4W (Received High Dose Maridebart Cafraglutide in Parent Trial)

Placebo Comparator group

Description:

Participants who received high dose of maridebart cafraglutide in the parent trial will be re-randomized in this trial to receive placebo SC Q4W.

Treatment:

Drug: Placebo

Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial)

Experimental group

Description:

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.

Treatment:

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial)

Experimental group

Description:

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.

Treatment:

Drug: Maridebart cafraglutide