MARITIME-3-J

Active not recruitingPhase 3

Efficacy and Safety of Maridebart Cafraglutide in Adult Participants in Japan Who Have Obesity Disease

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)

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

Recruiting sites

—

Enrollment

279

actual

Study population

Obesity / overweight

Key I/E criteria

•BMI ≥35•HbA1c 7-10%

Primary endpoints

•Body weight, % change•≥5% weight-loss responders

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT06987695

Org study ID20230144

Timeline

Milestones

Study first posted2025-05-23actual

Study start2025-06-13actual

Last update posted2025-12-17actual

Primary completion2027-04-27estimated

Study completion2027-07-21estimated

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Study populations

Who this study enrolls

Obesity / overweight

Eligibility

Who can enroll

Minimum age18 Years

Maximum age99 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (32)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

Glycemic / diabetes

Safety / tolerability / PK

Patient-reported / QoL

Weight & body composition

12 endpoints

Primary/protocol endpoint

Percent Change From Baseline in Body Weight at Week 72

Time frame:Baseline and Week 72

Body weight, % change

percent change from baseline, improvement

Primary/protocol endpoint

Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 72

Time frame:Baseline and Week 72

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Waist Circumference at Week 72

Time frame:Baseline and Week 72

Waist circumference, change

change from baseline, improvement

Secondary/protocol endpoint

Participants Achieving ≥ 10% Reduction in Body Weight from Baseline at Week 72

Time frame:Baseline and Week 72

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participants Achieving ≥ 15% Reduction in Body Weight from Baseline at Week 72

Time frame:Baseline and Week 72

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Body Weight at Week 72

Time frame:Baseline and Week 72

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight in Participants Without Type 2 Diabetes Mellitus (T2DM) at Week 72

Time frame:Baseline and Week 72

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Body Weight in Participants With T2DM at Week 72

Time frame:Baseline and Week 72

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Body Mass Index (BMI) at Week 72

Time frame:Baseline and Week 72

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Participants Achieving ≥ 20% Reduction in Body Weight from Baseline at Week 72

Time frame:Baseline and Week 72

≥20% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Visceral Fat Area (VFA) at Week 72

Time frame:Baseline and Week 72

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Participants Achieving VFA < 100 cm^2 in VFA at Week 72

Time frame:Week 72

Visceral fat, change

threshold achievement, improvement

Glycemic / diabetes

7 endpoints

Secondary/protocol endpoint

Change From Baseline in Fasting Plasma Glucose at Week 72

Time frame:Baseline and Week 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Insulin at Week 72

Time frame:Baseline and Week 72

percent change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c) at Week 72

Time frame:Baseline and Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

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

categorical status, improvement

Secondary/protocol endpoint

Participants With T2DM Achieving HbA1c < 7% at Week 72

Time frame:Week 72

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants With T2DM Achieving HbA1c ≤ 6.5% at Week 72

Time frame:Week 72

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participants With T2DM Achieving HbA1c < 5.7% at Week 72

Time frame:Week 72

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Cardiometabolic biomarkers

8 endpoints

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Total Cholesterol at Week 72

Time frame:Baseline and Week 72

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (non-HDL-C) at Week 72

Time frame:Baseline and Week 72

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C) at Week 72

Time frame:Baseline and Week 72

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Triglycerides at Week 72

Time frame:Baseline and Week 72

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Percent Change From Baseline in Fasting Very Low-density Lipoprotein Cholesterol (VLDL-C) at Week 72

Time frame:Baseline and Week 72

VLDL, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline in Fasting High-density Lipoprotein Cholesterol (HDL-C) at Week 72

Time frame:Baseline and Week 72

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure (SBP) at Week 72

Time frame:Baseline and Week 72

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure (DBP) at Week 72

Time frame:Baseline and Week 72

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Patient-reported / QoL

2 endpoints

Secondary/protocol endpoint

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

SF-36 physical

change from baseline, improvement

Secondary/protocol endpoint

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

IWQOL-Lite physical

change from baseline, improvement

Safety / tolerability / PK

3 endpoints

Secondary/protocol endpoint

Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)

Time frame:Up to Week 84

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants Experiencing Serious Adverse Events

Time frame:Up to Week 84

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Plasma Concentration of Maridebart Cafraglutide at Week 72

Time frame:Week 72

Plasma concentration (steady state)

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.