DelfaGLP-1 Atlas

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MARITIME-2

Active not recruitingPhase 3

Efficacy and Safety of Maridebart Cafraglutide in Adult Participants With 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 With Type 2 Diabetes Mellitus Who Have Obesity or Are Overweight (MARITIME-2)

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

187

Recruiting sites

—

Enrollment

1,105

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI ≥27

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 IDNCT06858878
Org study ID20210184

Timeline

Milestones

Study first posted2025-03-05actual
Study start2025-03-17actual
Last update posted2025-12-31actual
Primary completion2027-01-21estimated
Study completion2027-04-16estimated

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age99 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age ≥ 18 years.
•Body mass index ≥ 27 kg/m^2.
•History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.
•Diagnosis of T2DM.

Exclusion criteria

•Type 1 diabetes mellitus.
•Self-reported change in body weight > 5 kg within 90 days before screening.
•Proliferative diabetic retinopathy OR diabetic macular edema OR non-proliferative diabetic retinopathy that requires acute treatment.
•Obesity induced by other endocrinologic disorders.
•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 (29)

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

Cardiometabolic biomarkers
9
Weight & body composition
8
Glycemic / diabetes
6
Safety / tolerability / PK
3
Patient-reported / QoL
2
Renal / kidney
1

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:Baseline and 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:Baseline and 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: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

Participant 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 Body Mass Index (BMI) at Week 72

Time frame:Baseline and Week 72

BMI, change

change from baseline, improvement

Glycemic / diabetes

6 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

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

Participant achieving HbA1c < 7% at week 72

Time frame:Week 72

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participant achieving HbA1c ≤ 6.5% at week 72

Time frame:Week 72

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Participant achieving HbA1c < 5.7%, at week 72

Time frame:Week 72

HbA1c <5.7% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Percent Change from Baseline in Fasting Insulin at Week 72

Time frame:Baseline and Week 72

percent change from baseline, improvement

Renal / kidney

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Urine Albumin-to-creatinine Ratio (uACR) at Week 72

Time frame:Baseline and Week 72

uACR, change

change from baseline, improvement

LOINC 9318-7

Cardiometabolic biomarkers

9 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 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

Secondary/protocol endpoint

Percent Change from Baseline at Week 72 in Fasting Concentration of Total Cholesterol

Time frame:Baseline and Week 72

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

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

Time frame:Baseline and Week 72

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and Week 72

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Percent Change from Baseline at Week 72 in Fasting Concentration of Very-low-density Lipoprotein Cholesterol (VLDL-C)

Time frame:Baseline and Week 72

VLDL, change

percent change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and Week 72

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

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 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

3 endpoints
Secondary/protocol endpoint

Number of Participants who Experienced Treatment-emergent Adverse Events

Time frame:Up to Week 84

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants who Experienced 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.