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

NCT07684235 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 1 other identifier: 20250197
• Study Type: interventional
• Target: 3,200
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Overweight; Obesity

Keywords

Overweight; BMI; Obesity; Maridebart cafraglutide; Chronic weight management; MariTide; Extension; Long-Term

Outcome Measures

Primary Outcomes (2)

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

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

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

  Baseline of current trial up to 60 weeks

Secondary Outcomes (11)

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

  Baseline of parent trial to Week 48 of current trial

• Percentage of Participants Achieving ≥10% Reduction in Body Weight from Baseline of the Parent Trial

  Baseline of parent trial to Week 48 of current trial

• Percentage of Participants Achieving ≥15% Reduction in Body Weight from Baseline of the Parent Trial

  Baseline of parent trial to Week 48 of current trial

• Percentage of Participants Achieving ≥20% Reduction in Body Weight from Baseline of the Parent Trial

  Baseline of parent trial to Week 48 of current trial

• Change from Baseline of the Parent Trial in Waist Circumference

  Baseline of parent trial to Week 48 of current trial

Study Arms (10)

Maridebart Cafraglutide Low Dose Q4W

EXPERIMENTAL

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).

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Medium Dose Q4W

EXPERIMENTAL

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.

Drug: Maridebart cafraglutide

Maridebart Cafraglutide Medium Dose Q8W

EXPERIMENTAL

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).

Drug: Maridebart cafraglutide

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

PLACEBO COMPARATOR

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

Drug: Placebo

Maridebart Cafraglutide High Dose Q4W

EXPERIMENTAL

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.

Drug: Maridebart cafraglutide

Maridebart Cafraglutide High Dose Q8W

EXPERIMENTAL

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.

Drug: Maridebart cafraglutide

Maridebart Cafraglutide High Dose Q12W

EXPERIMENTAL

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).

Drug: Maridebart cafraglutide

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

PLACEBO COMPARATOR

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

Drug: Placebo

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

EXPERIMENTAL

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.

Drug: Maridebart cafraglutide

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

EXPERIMENTAL

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.

Drug: Maridebart cafraglutide

Interventions

Maridebart cafraglutide DRUG

Administered subcutaneously

Also known as: AMG 133, MariTide

Maridebart Cafraglutide High Dose Q12W; Maridebart Cafraglutide High Dose Q4W; Maridebart Cafraglutide High Dose Q4W (Received Placebo in the Parent Trial); Maridebart Cafraglutide High Dose Q8W; Maridebart Cafraglutide Low Dose Q4W; Maridebart Cafraglutide Low Dose Q4W(Received Very Low Dose Maridebart Cafraglutide in Parent Trial); Maridebart Cafraglutide Medium Dose Q4W; Maridebart Cafraglutide Medium Dose Q8W

Placebo DRUG

Administered subcutaneously.

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

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Amgen: lead

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2026
• First Posted: July 6, 2026
• Study Start: July 29, 2026
• Primary Completion (Estimated): December 26, 2027
• Study Completion (Estimated): March 19, 2028
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s).In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.