Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease (MARITIME-3-J)

December 15, 2025 updated by: Amgen

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease (MARITIME 3-J)

The primary objective of this study is to demonstrate that maridebart cafraglutide is superior to placebo for percent change in body weight and proportion of participants with ≥ 5% reduction in body weight.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
279

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 451-8511
        • Meitetsu Hospital
      • Nagoya, Aichi-ken, Japan, 453-0812
        • Hosokawa Surgical Clinic
      • Nagoya, Aichi-ken, Japan, 457-8511
        • Social Medical Corporation Kojunkai Daido Clinic
    • Fukuoka
      • Fukuoka, Fukuoka, Japan, 812-8582
        • Kyushu University Hospital
      • Fukuoka, Fukuoka, Japan, 810-0001
        • Wellness Tenjin Clinic
      • Fukuoka, Fukuoka, Japan, 812-0025
        • Medical Corporation Boocs Boocs Clinic Fukuoka
      • Fukuoka, Fukuoka, Japan, 814-0153
        • Tashiro Endocrinology Clinic
      • Onga-gun, Fukuoka, Japan, 807-0051
        • Fukuoka Shinmizumaki Hospital
    • Gifu
      • Hashima-gun, Gifu, Japan, 501-6061
        • Matsunami Health Promotion Clinic
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 060-0062
        • Manda Memorial Hospital
    • Hyōgo
      • Amagasaki-shi, Hyōgo, Japan, 660-0861
        • Yamasaki Family Clinic
      • Kobe, Hyōgo, Japan, 650-0017
        • Kobe University Hospital
      • Kobe, Hyōgo, Japan, 652-0803
        • Deguchi Clinic
    • Ibaraki
      • Naka, Ibaraki, Japan, 311-0133
        • Nishiyamado Keiwa Hospital
    • Kagoshima-ken
      • Aira-shi, Kagoshima-ken, Japan, 899-5421
        • Aira Diabetes Thyroid Internal Medicine Clinic
    • Kanagawa
      • Kawasaki-shi, Kanagawa, Japan, 212-0024
        • Matsuba Clinic
    • Kyoto
      • Kyoto, Kyoto, Japan, 606-8507
        • Kyoto University Hospital
      • Kyoto, Kyoto, Japan, 600-8898
        • Medical Corporation KEISEIKAI Kajiyama Clinic
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 852-8034
        • Midori Clinic
    • Okinawa
      • Urasoe-shi, Okinawa, Japan, 901-2102
        • Urasoe General Hospital
    • Osaka
      • Osaka, Osaka, Japan, 530-0002
        • Joh Medical Clinic
    • Tokyo
      • Adachi-ku, Tokyo, Japan, 120-0022
        • Adachi Kyosai Hospital
      • Chuo-ku, Tokyo, Japan, 103-0025
        • Nihonbashi Sakura Clinic
      • Chuo-ku, Tokyo, Japan, 103-0027
        • Medical Corporation Chiseikai Tokyo Center Clinic
      • Hachioji-shi, Tokyo, Japan, 192-0918
        • Medical Corporation Kenshinkai Minamino Cardiovascular Hospital
      • Minato-ku, Tokyo, Japan, 108-0073
        • Tokyo Saiseikai Central Hospital
      • Nerima-ku, Tokyo, Japan, 177-0051
        • Shimamura Memorial Hospital
      • Shibuya-ku, Tokyo, Japan, 151-0051
        • Mih Clinic Yoyogi
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Shinjuku Southern Clinic
      • Toshima-ku, Tokyo, Japan, 171-0021
        • Ikebukuro Metropolitan Clinic

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years.
  • History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
  • Body mass index (BMI) ≥ 35 kg/m^2 at screening with a current diagnosis of at least 1 of the weigh-related comorbidities specified in the Japan Society for the Study of Obesity (JASSO) guideline OR BMI ≥ 27 kg/m^2 to < 35 kg/m^2 at screening, with a current diagnosis of at least 2 of the weight-related comorbidities specified in the JASSO guideline.

  • For both BMI categories, at least 1 of the weight-related comorbidities must be hypertension, dyslipidemia, or T2DM according to the definitions below:

    1. hypertension: treated, or with SBP ≥ 140 mmHg, or DBP ≥ 90 mmHg at screening.
    2. dyslipidemia: treated, or with LDL > 140 mg/dL (3.6 mmol/L), or triglycerides ≥ 150 mg/dL (1.7 mmol/L), or non-HDL cholesterol > 170 mg/dL (4.4 mmol/L) or HDL < 40 mg/dL (1.0 mmol/L) at screening.
    3. T2DM: diagnosed ≥ 180 days before screening, and treated with diet and exercise alone and/or a stable treatment for at least 90 days before screening with up to 3 oral glucose-lowering medications (as per local labeling) (except for glucagon-like peptide-1 receptor agonists [GLP-1RA] and dipeptidyl peptidase-4 [DPP-4] inhibitors), and have a HbA1c ≥ 7% and ≤ 10% (53-86 mmol/mol) at screening.

  • In the opinion of the investigator, well-motivated and willing to:

    1. Follow study procedures for the duration of the study, including, but not limited to, follow lifestyle advice, maintain a study log(s)/diary(ies), and complete required study visits and questionnaires.
    2. Perform self-monitoring blood glucose (SMBG) per protocol (only for participants with T2DM).

Exclusion Criteria:

  • Obesity induced by other endocrinological disorders or monogenetic or syndromic forms of obesity.
  • Self-reported change in body weight > 5 kg within 90 days before screening.
  • Previous or planned (during the study) surgical, endoscopic, or device-based treatment for obesity.
  • For participants without diabetes at screening, type 1 or 2 diabetes mellitus or any other types of diabetes mellitus (except history of gestational diabetes).
  • For participants with T2DM at screening, any other type(s) of diabetes mellitus except T2DM.
  • History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.
  • Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 (MEN-2).
  • History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.
  • Lifetime history of suicide attempt.

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: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Maridebart Cafraglutide High Dose
Participants will receive maridebart cafraglutide high dose subcutaneously (SC) for 72 weeks.
Drug: Maridebart cafraglutide
Maridebart cafraglutide will be administered SC.
Other Names:
  • AMG 133
  • MariTide
Experimental: Maridebart Cafraglutide Medium Dose
Participants will receive maridebart cafraglutide medium dose SC for 72 weeks.
Drug: Maridebart cafraglutide
Maridebart cafraglutide will be administered SC.
Other Names:
  • AMG 133
  • MariTide
Experimental: Maridebart Cafraglutide Low Dose
Participants will receive maridebart cafraglutide low dose SC for 72 weeks.
Drug: Maridebart cafraglutide
Maridebart cafraglutide will be administered SC.
Other Names:
  • AMG 133
  • MariTide
Placebo Comparator: Placebo
Participants will receive placebo SC for 72 weeks.
Drug: Placebo
Placebo will be administered SC.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percent Change From Baseline in Body Weight at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Plasma Concentration of Maridebart Cafraglutide at Week 72
Time Frame: Week 72
Week 72
Change From Baseline in Waist Circumference at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Change From Baseline in Systolic Blood Pressure (SBP) at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Percent Change From Baseline in Fasting Triglycerides at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Change From Baseline in Body Weight at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Change From Baseline in Body Mass Index (BMI) at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Percent Change From Baseline in Fasting Insulin at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Change From Baseline in Diastolic Blood Pressure (DBP) at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Change From Baseline in Short Form 36 Health Survey Version 2 (SF-36v2) Acute Physical Function Domain Score at Week 72
Time Frame: Baseline and Week 72
The SF-36v2 Acute Physical Function domain score measures an individual's ability to perform daily physical activities, such as walking and climbing stairs, over the past week. It includes 10 items scored on a 3-point Likert scale, with raw scores transformed to a 0-100 scale. Higher scores indicate better physical functioning and fewer limitations due to physical health.
Baseline and Week 72
Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Percent Change From Baseline in Body Weight in Participants Without Type 2 Diabetes Mellitus (T2DM) at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Percent Change From Baseline in Body Weight in Participants With T2DM at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Participants Achieving ≥ 20% Reduction in Body Weight from Baseline at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Change From Baseline in Visceral Fat Area (VFA) at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Participants Achieving VFA < 100 cm^2 in VFA at Week 72
Time Frame: Week 72
Week 72
Percent Change From Baseline in Fasting Total Cholesterol at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Percent Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (non-HDL-C) at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Percent Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C) at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Percent Change From Baseline in Fasting Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Percent Change From Baseline in Fasting High-density Lipoprotein Cholesterol (HDL-C) at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Change From Baseline in Fasting Plasma Glucose at Week 72
Time Frame: Baseline and Week 72
Baseline and Week 72
Percentage of Participants with a Change from Baseline in Glycemic Status at Week 72 for Participants Without T2DM at Baseline
Time Frame: Baseline and Week 72

Glycemic status was categorized as:

  • normoglycemic (fasting plasma glucose < 100 mg/dL and HbA1c < 5.7%, in absence of T2DM diagnosis),
  • prediabetes (fasting plasma glucose 100 - 125 mg/dL or HbA1c 5.7% - 6.4% in the absence of a T2DM diagnosis),
  • or, T2DM (fasting plasma glucose ≥ 126 mg/dL and HbA1c ≥6.5%).
Baseline and Week 72
Participants With T2DM Achieving HbA1c < 7% at Week 72
Time Frame: Week 72
Week 72
Participants With T2DM Achieving HbA1c ≤ 6.5% at Week 72
Time Frame: Week 72
Week 72
Participants With T2DM Achieving HbA1c < 5.7% at Week 72
Time Frame: Week 72
Week 72
Change from Baseline in the Impact of Weight on Quality of Life-Lite Clinical Trials Version (IWQOL-Lite-CT) Physical Function Composite Score at Week 72
Time Frame: Baseline and Week 72
The IWQOL-Lite-CT is a 20-item questionnaire designed to assess the impact of weight on quality of life in clinical trials. Items are scored on a 5-point Likert scale, with raw scores transformed to a 0-100 scale, where higher scores indicate better quality of life and less weight-related impact.
Baseline and Week 72
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to Week 84
Up to Week 84
Number of Participants Experiencing Serious Adverse Events
Time Frame: Up to Week 84
Up to Week 84

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Amgen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 13, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 21, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 2, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 23, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 17, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 15, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230144

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

product manufactured in and exported from the U.S.

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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