Maridebart Cafraglutide Versus Semaglutide in Participants With Type 2 Diabetes (MARITIME-T2D-3)

November 3, 2026 updated by: Amgen

A Phase 3, Randomized, Open-Label Trial Comparing the Efficacy and Safety of Maridebart Cafraglutide Once Monthly Versus Semaglutide Once Weekly as Add-on Therapy to Metformin With or Without a Sodium-glucose Cotransporter-2 Inhibitor in Participants With Type 2 Diabetes

The main objective of this trial is to evaluate whether maridebart cafraglutide is non-inferior to semaglutide in improving glycemic control in participants with type 2 diabetes (T2D) who are receiving metformin treatment, with or without a sodium-glucose cotransporter-2 (SGLT-2) inhibitor.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

1300

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

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Y 3W2
        • Recruiting
        • Dr T G Elliott Incorporated - BC Diabetes
  • United States
    • California
      • San Diego, California, United States, 92120
        • Recruiting
        • Acclaim Clinical Research
    • Florida
      • Miami, Florida, United States, 33155
        • Recruiting
        • Bioclinical Research Alliance
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Indago Research and Health Center
      • Pompano Beach, Florida, United States, 33060
        • Recruiting
        • Clinical Research Center Of Florida
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research - Winter Park
    • Virginia
      • Arlington, Virginia, United States, 22205
        • Recruiting
        • Virginia Nephrology Group
    • Washington
      • Redmond, Washington, United States, 98052
        • Recruiting
        • Eastside Research Associates Health 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HbA1c of ≥ 7.5% (58.0 millimoles per mole (mmol/mol)) and ≤ 10.5% (91.0 mmol/mol) at screening.
  • Treatment of Type 2 diabetes (T2D) with metformin (≥ 1500 milligrams per day (mg/day), or maximum tolerated dose as per investigator judgment) with or without an sodium-glucose cotransporter-2 (SGLT-2) inhibitor on a stable total daily dose for at least 90 days prior to randomization.
  • Body mass index (BMI) ≥ 25 kilograms per meter squared (kg/m^2) at screening.

Exclusion Criteria:

  • Type 1 diabetes mellitus (T1DM), history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus except T2D or past history of gestational diabetes.

  • Participants who are currently receiving or planning to receive treatment for diabetic retinopathy and/or macular edema.

  • Participants who have a diagnosis of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy.

  • One or more episode of severe hypoglycemia (Level 3 hypoglycemia) within 180 days before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.

  • History of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.

  • Self-reported change in body weight > 5% within 90 days before screening. Participants must also agree to not initiate an intensive diet or exercise program during the trial with the intent of reducing body weight, other than the lifestyle and/or dietary measures for diabetes treatment.

  • Previous or planned (during the trial) surgical, endoscopic, or device-based treatment for obesity. The following are allowed:

    • liposuction and/or abdominoplasty that was performed > 1 year before screening.
    • laparoscopic adjustable gastric banding, intragastric balloon, and/or duodenal-jejunal bypass liner or gastric sleeve if removed > 1 year before screening.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Maridebart cafraglutide

Participants will receive maridebart cafraglutide administered subcutaneously (SC) once every 4 weeks (Q4W) in a dose-escalation manner.
Drug: Maridebart cafraglutide

Administered subcutaneously.

Other Names:
  • AMG 133
  • MariTide
Active Comparator: Semaglutide

Participants will receive semaglutide administered SC once weekly (QW) in a dose-escalation manner.
Drug: Semaglutide

Administered subcutaneously.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 68 [Non-inferiority]
Time Frame: Baseline to Week 68
Baseline to Week 68

Secondary Outcome Measures

Outcome Measure
Time Frame
Plasma Concentration of Maridebart Cafraglutide at Week 68
Time Frame: Week 68
Week 68
Change from Baseline in HbA1c at week 68 [Superiority]
Time Frame: Baseline to Week 68
Baseline to Week 68
Percent Change from Baseline in Body Weight at Week 68
Time Frame: Baseline to Week 68
Baseline to Week 68
Percentage of Participants Achieving HbA1c < 7.0% at Week 68
Time Frame: Week 68
Week 68
Percentage of Participants Achieving HbA1c ≤ 6.5% at Week 68
Time Frame: Week 68
Week 68
Percentage of Participants Achieving HbA1c < 5.7% at Week 68
Time Frame: Week 68
Week 68
Change from Baseline in Fasting Plasma Glucose at Week 68
Time Frame: Baseline to Week 68
Baseline to Week 68
Percentage of Participants Achieving ≥ 5% Reduction in Body Weight from Baseline at Week 68
Time Frame: Baseline to Week 68
Baseline to Week 68
Percentage of Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 68
Time Frame: Baseline to Week 68
Baseline to Week 68
Percentage of Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 68
Time Frame: Baseline to Week 68
Baseline to Week 68
Percentage of Participants Achieving HbA1c ≤ 6.5% and Weight Reduction ≥ 10% from Baseline at Week 68
Time Frame: Baseline to Week 68
Baseline to Week 68
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Up To 81 Weeks
Up To 81 Weeks
Number of Participants Experiencing ≥ Level 2 American Diabetes Association (ADA) Defined Hypoglycemic Episodes
Time Frame: Up To 81 Weeks
Up To 81 Weeks

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 16, 2026

Primary Completion (Estimated)

September 6, 2028

Study Completion (Estimated)

December 5, 2028

Study Registration Dates

First Submitted

October 5, 2026

First Submitted That Met QC Criteria

October 5, 2026

First Posted (Actual)

October 8, 2026

Study Record Updates

Last Update Posted (Actual)

November 5, 2026

Last Update Submitted That Met QC Criteria

November 3, 2026

Last Verified

October 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230220
  • 2025 (U.S. NIH Grant/Contract)
  • 2025-523772-22-00 (Ctis)

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

No

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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