MARITIME-1

Active not recruitingPhase 3

Evaluation of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Participants Without Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

243

Recruiting sites

—

Enrollment

3,853

actual

Study population

Obesity / overweight

Key I/E criterion

•BMI ≥30

Primary endpoint

•Body weight, % change

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 IDNCT06858839

Org study ID20210181

Secondary ID2024-515524-36

Timeline

Milestones

Study first posted2025-03-05actual

Study start2025-03-12actual

Last update posted2025-10-20actual

Primary completion2027-01-21estimated

Study completion2027-04-16estimated

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.

•Body mass index ≥ 30 kg/m2 or ≥27 kg/m² to < 30 kg/m2 with at least 1 of the following weight-related comorbidities: hypertension, dyslipidemia, history of obstructive sleep apnea, history of cardiovascular disease, history of metabolic dysfunction-associated steatotic liver disease (MASLD) or Metabolic Dysfunction-Associated Steatohepatitis (MASH).

•History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

Exclusion criteria

•Type 1 or Typ2 diabetes mellitus.

•Obesity induced by other endocrinologic disorders.

•Self-reported change in body weight > 5 kg within 90 days before screening.

•Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2.

•History of chronic pancreatitis or history of acute pancreatitis within 180 days before screening.

•History of unstable major depressive disorder (MDD) or other severe psychiatric disorder within 2 years before screening.

•Lifetime history of suicide attempt.

Endpoints (21)

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

Patient-reported / QoL

Safety / tolerability / PK

Weight & body composition

8 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

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

Participant achieving ≥ 5% reduction in body weight from baseline at week 72

Time frame:Week 72

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participant achieving ≥ 10% reduction in body weight from baseline at week 72

Time frame:Week 72

≥10% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participant achieving ≥ 15% reduction in body weight from baseline at week 72

Time frame:Week 72

≥15% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Participant achieving ≥ 20% reduction in body weight from baseline at week 72

Time frame:Week 72

≥20% 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

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

Time frame:Baseline and Week 72

BMI, change

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Secondary/protocol endpoint

Change From Baseline in Fasting Glucose at Week 72

Time frame:Baseline and Week 72

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change From Baseline in Hemoglobin A1c at Week 72

Time frame:Baseline and Week 72

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Percent Change From Baseline in Fasting Insulin at Week 72

Time frame:Baseline and Week 72

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change From Baseline in Glycemic Status at Week 72

Time frame:Baseline and Week 72

change from baseline, improvement

Cardiometabolic biomarkers

5 endpoints

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

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 Lipid Parameters at Week 72

Time frame:Baseline and Week 72

percent change from baseline, improvement

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

Secondary/protocol endpoint

Percent Change From Baseline in High-sensitivity C-reactive Protein (hs-CRP) at Week 72

Time frame:Baseline and Week 72

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Patient-reported / QoL

2 endpoints

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

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

Safety / tolerability / PK

2 endpoints

Secondary/protocol endpoint

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

Time frame:Up to approximately 88 weeks

Treatment-emergent 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.