DelfaGLP-1 Atlas

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Active not recruitingPhase 2

A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)

A Study to Evaluate the Efficacy, Safety & Tolerability of Maridebart Cafraglutide in Adults With T2DM

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

96

Recruiting sites

—

Enrollment

409

actual

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI 23-50•HbA1c 7-10.5%

Primary endpoint

•HbA1c, 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 IDNCT06660173
Org study ID20230143
Secondary ID2024-513539-25-00

Timeline

Milestones

Study first posted2024-10-28actual
Study start2024-11-07actual
Primary completion2025-10-06actual
Last update posted2025-11-25actual
Study completion2026-11-10estimated

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Age ≥ 18 years at screening (or ≥ legal age within the country if it is older than 18 years)
•Type 2 diabetes for ≥6 months according to the World Health Organization classification
•HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory
•Treatment of diabetes with diet and exercise alone, or with a stable dose of metformin, with or without a sodium-glucose cotransporter-2 inhibitor, for at least 3 months prior to screening
•Body mass index of 23 to 50 kilograms per square meter

Exclusion criteria

•Type 1 diabetes
•Use of any glucose-lowering medication, other than metformin with or without a sodium-glucose cotransporter-2 inhibitor, within 3 months prior to screening
•Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology equation.
•Uncontrolled and potentially unstable diabetic retinopathy or maculopathy
•History of acute or chronic pancreatitis
•Malignancy within 5 years before screening, except for nonmelanoma skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer
•Myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention, transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure within 90 days prior to screening, or currently have New York Heart Association Class III or IV heart failure.
•Use of medications that affect glucose control or body weight or history of bariatric surgery or procedures.

Endpoints (22)

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
10
Safety / tolerability / PK
5
Glycemic / diabetes
4
Weight & body composition
3

Weight & body composition

3 endpoints
Secondary/protocol endpoint

Percent Change From Baseline to Week 24 in Body Weight

Time frame:Baseline to Week 24

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Number of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 24

Time frame:Week 24

≥5% weight-loss responders

threshold achievement, improvement

Secondary/protocol endpoint

Number of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 24

Time frame:Week 24

≥10% weight-loss responders

threshold achievement, improvement

Glycemic / diabetes

4 endpoints
Primary/protocol endpoint

Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c)

Time frame:Baseline to Week 24

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants Achieving HbA1c < 7.0% at Week 24

Time frame:Week 24

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Number of Participants Achieving HbA1c ≤ 6.5% at Week 24

Time frame:Week 24

HbA1c <6.5% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline to Week 24 in Fasting Glucose

Time frame:Baseline to Week 24

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

10 endpoints
Secondary/protocol endpoint

Percent Change From Baseline to Week 24 in Total Cholesterol

Time frame:Baseline to Week 24

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percent Change From Baseline to Week 24 in Low-density Lipoprotein Cholesterol (LDL-C)

Time frame:Baseline to Week 24

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Percent Change From Baseline to Week 24 in High-density Lipoprotein Cholesterol (HDL-C)

Time frame:Baseline to Week 24

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Percent Change From Baseline to Week 24 in Non-high Density Lipoprotein Cholesterol (non-HDL-C)

Time frame:Baseline to Week 24

Non-HDL cholesterol, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline to Week 24 in Very-low-density Lipoprotein Cholesterol (VLDL-C)

Time frame:Baseline to Week 24

VLDL, change

percent change from baseline, improvement

Secondary/protocol endpoint

Percent Change From Baseline to Week 24 in Triglycerides

Time frame:Baseline to Week 24

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Percent Change From Baseline to Week 24 in Free Fatty Acids (FFA)

Time frame:Baseline and Week 24

Free fatty acids, change

percent change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline to Week 24 in Systolic Blood Pressure

Time frame:Baseline and Week 24

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline to Week 24 in Diastolic Blood Pressure

Time frame:Baseline and Week 24

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Change from Baseline to Week 24 in High-sensitivity C-reactive Protein

Time frame:Baseline and Week 24

hs-CRP, change

change from baseline, improvement

LOINC 30522-7

Safety / tolerability / PK

5 endpoints
Secondary/protocol endpoint

Pre-dose Plasma Concentration of Maridebart Cafraglutide at Week 20

Time frame:Week 20

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Maximum Observed Plasma Concentration of Maridebart Cafraglutide at Week 20

Time frame:Week 20

Cmax

concentration, descriptive

Secondary/protocol endpoint

Number of Participants with Treatment Emergent Adverse Events

Time frame:Up to 24 Weeks

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants with Serious Adverse Events

Time frame:Up to 24 Weeks

Serious AEs (any)

event count, event

Secondary/protocol endpoint

Number of Participants with Anti-maridebart Cafraglutide Antibody Formation

Time frame:Up to Week 24

Immunogenicity (ADA)

threshold achievement, event

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.