Home Self-administration of Maridebart Cafraglutide With Autoinjector in Adults Living With Obesity or Overweight (MARITIME-PEN)

November 5, 2026 updated by: Amgen

A Phase 3 Multicenter, Open-label, Single-arm Trial Evaluating Home Self-Administration of Subcutaneous Maridebart Cafraglutide Via Autoinjector in Adult Participants Living With Obesity or Overweight Without Type 2 Diabetes Mellitus

The main objective of this study is to assess participants' ability to self-administer subcutaneous doses of maridebart cafraglutide at home using an autoinjector device.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

230

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Latin Clinical Trial Center
  • United States
    • California
      • San Diego, California, United States, 92120
        • Recruiting
        • Apex Clinical Research
    • Florida
      • Miami, Florida, United States, 33173
        • Recruiting
        • Research Institute of South Florida
      • Miami, Florida, United States, 33125
        • Recruiting
        • Southern Clinical Research
      • Orlando, Florida, United States, 32825
        • Recruiting
        • Florida Institute for Clinical Research
      • Orlando, Florida, United States, 32801
        • Recruiting
        • Clinical Neuroscience Solutions LLC
      • The Villages, Florida, United States, 32162
        • Recruiting
        • Charter Research - The Villages
    • Georgia
      • Johns Creek, Georgia, United States, 30024
        • Recruiting
        • Nsc Research
      • Woodstock, Georgia, United States, 30189
        • Recruiting
        • North Georgia Clinical Research
    • Idaho
      • Meridian, Idaho, United States, 83646
        • Recruiting
        • Solaris Clinical Research
    • Illinois
      • Oak Brook, Illinois, United States, 60523
        • Recruiting
        • Alliance For Multispecialty Research - Oak Brook
    • Maryland
      • Bowie, Maryland, United States, 20715
        • Recruiting
        • Flourish Research
    • New York
      • Rochester, New York, United States, 14609
        • Recruiting
        • Rochester Clinical Research
    • North Carolina
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Centricity Research
    • Ohio
      • Columbus, Ohio, United States, 43213
        • Recruiting
        • Centricity Research Dublin
    • Oklahoma
      • Chickasha, Oklahoma, United States, 73018
        • Recruiting
        • Epic Medical Research - Oklahoma
    • South Carolina
      • Greenville, South Carolina, United States, 29607
        • Recruiting
        • Tribe Clinical Research LLC Dba Mountain View Clinical Research
    • Texas
      • Dallas, Texas, United States, 75251
        • Recruiting
        • Cedar Health Research, LLC
      • Dallas, Texas, United States, 75235
        • Recruiting
        • Cedar Health Research- Texas Native Health
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • Epic Medical Research - Red Oak
      • Denison, Texas, United States, 75020
        • Recruiting
        • Soma Clinical Trials, LLC
      • Houston, Texas, United States, 77043
        • Recruiting
        • Biopharma Informatic, LLC
      • Houston, Texas, United States, 77089
        • Recruiting
        • Research Physicians Network LLC
      • McKinney, Texas, United States, 75071
        • Recruiting
        • Texas Institute of Cardiology
      • North Richland Hills, Texas, United States, 76180
        • Recruiting
        • North Hills Medical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Body mass index (BMI) ≥ 30 kilograms per meter square (kg/m^2), or BMI ≥ 27 to < 30 kg/m^2 with one of the following:

    • hypertension: treated, or with systolic blood pressure ≥ 130 millimeters of mercury (mmHg) or diastolic blood pressure ≥ 80 mmHg
    • dyslipidemia: treated or previously diagnosed high cholesterol, high triglycerides, or low HDL cholesterol.
    • history of obstructive sleep apnea
    • history of cardiovascular disease
    • history of fatty liver disease (including metabolic dysfunction-associated steatotic liver disease [MASLD] or metabolic dysfunction-associated steatohepatitis [MASH])

  • At least 1 unsuccessful attempt at weight loss by diet and exercise.

  • Contraception for females.

  • Willingness to follow trial procedures for the duration of the trial.

Exclusion Criteria:

  • Obesity induced by other endocrinologic disorders.
  • Change in body weight > 5 kg within last 90 days.
  • Previous or planned surgical, endoscopic, or device-based treatment for obesity.
  • History of malignancy within the past 5 years.
  • Type 1 or Type 2 diabetes mellitus.
  • History of chronic pancreatitis or history of acute pancreatitis within last 180 days.
  • Family or personal history of medullary thyroid cancer.
  • Previous participation in a Maridebart Cafraglutide trial.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maridebart cafraglutide

Participants will receive 8 total doses of subcutaneous (SC) injections of maridebart cafraglutide.
Drug: Maridebart cafraglutide

Administered subcutaneously.

Other Names:
  • AMG 133
  • MariTide
Device: Autoinjector

The AI will be used by participants to self-administer SC doses of maridebart cafraglutide.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of Participants Who Successfully Self-inject a Full Dose Among Those Who Attempted Injection at Each Home Administration
Time Frame: Weeks 12, 16, and 20
Weeks 12, 16, and 20
Percentage of Participants Who Successfully Self-inject a Full Dose Among All Participants Who Entered the Home Self-administration Phase at Each Scheduled Home Administration
Time Frame: Weeks 12, 16, and 20
Weeks 12, 16, and 20

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change From Baseline in Body Weight at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Number of Participants Who Experience Device-related Adverse Events
Time Frame: Up To 37 weeks
Up To 37 weeks
Number of Participants Who Experience Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: TEAEs: From baseline (Day 1) up to end of trial (approximately 37 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 41 weeks).
TEAEs: From baseline (Day 1) up to end of trial (approximately 37 weeks). SAEs: From screening (Day -28) up to end of trial (approximately 41 weeks).
Plasma Concentration of Maridebart Cafraglutide at Week 24
Time Frame: Week 24
Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amgen

Investigators

  • Study Director: MD, Amgen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2026

Primary Completion (Estimated)

June 16, 2027

Study Completion (Estimated)

September 8, 2027

Study Registration Dates

First Submitted

October 7, 2026

First Submitted That Met QC Criteria

October 7, 2026

First Posted (Actual)

October 13, 2026

Study Record Updates

Last Update Posted (Actual)

November 9, 2026

Last Update Submitted That Met QC Criteria

November 5, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20250207

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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