DelfaGLP-1 Atlas

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RecruitingPhase 1

A Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus

A Phase 1, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of Maridebart Cafraglutide on Insulin Sensitivity and β-cell Function in Participants With Type 2 Diabetes Mellitus

Lead sponsor

Amgen

Asset

Maridebart cafraglutide / MariTide

Subcutaneous · GLP-1 agonist / GIP antagonist

Listed sites

1

Recruiting sites

1

Enrollment

57

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criterion

•BMI 25-45

Primary endpoint

•M-value from Hyperinsulinemic-euglycemic Clamp

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 IDNCT07160257
Org study ID20250061

Timeline

Milestones

Study start2025-08-05actual
Study first posted2025-09-08actual
Last update posted2026-05-18actual
Primary completion2026-11-02estimated
Study completion2027-02-19estimated

Assets

Investigational agents

Maridebart cafraglutide / MariTide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Informed consent before initiation of any study-specific activities/procedures.
•Male or female participants aged ≥ 18 and ≤ 70 years at the time of signing informed consent.
•Body mass index ≥ 23.0 kg/m^2 (Asian participants only) or ≥ 25 and ≤ 45 kg/m^2 at screening.
•Diagnosis of T2DM at least 6 months before screening based on the WHO classification.
•Treatment of T2DM for at least 3 months prior to screening with diet and exercise and a stable dose of metformin (either immediate release or extended release), with or without a stable dose of 1 additional OAM other than metformin.

Exclusion criteria

•Type 1 diabetes mellitus, history of ketoacidosis or hyperosmolar state/coma, or any other type of diabetes mellitus (except T2DM or history of gestational diabetes).
•History of proliferative diabetic retinopathy or diabetic macular edema or nonproliferative diabetic retinopathy that requires acute treatment.
•One or more episodes of severe hypoglycemia (Level 3 hypoglycemia as defined by the American Diabetes Association classification criteria) within 6 months before screening, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery.
•Has modified diet or adopted any nutritional lifestyle modifications within 3 months prior to screening, as assessed by the investigator (or designee) based on participant self-report.
•History of malignancy within the last 5 years before screening (except nonmelanoma skin cancers, cervical carcinoma in situ, or breast ductal carcinoma in situ).
•Family (first-degree relative[s]) or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2 (MEN-2).
•History or evidence of endocrine disorder (such as Cushing's syndrome) that can cause obesity.
•History or evidence of autoimmune disease that can directly or indirectly affect insulin production, insulin action, or glucose metabolism.
•History of any of the following within 90 days before screening: myocardial infarction, unstable angina, coronary artery bypass graft surgery or other major cardiovascular surgery, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident, or decompensated congestive heart failure, or currently have New York Heart Association Class III or IV heart failure.
•History of chronic pancreatitis.
•History of acute pancreatitis within 6 months before screening.
•Positive human immunodeficiency virus test at screening.
•Evidence of hepatitis B or C infection.
•Estimated glomerular filtration rate < 60 mL/min/1.73 m^2 calculated by the 2021 Chronic Kidney Disease Epidemiology Collaboration creatinine-cystatin C equation at screening.
•Hemoglobin value < 12 g/dL (males) or < 10 g/dL (females) at screening or check-in (Day -4).
•Use within 90 days before randomization of medications, supplements, or alternative remedies for weight loss (eg, GLP-1RA, GIP agonists, phentermine/topiramate, naltrexone/bupropion, orlistat, and sympathomimetic drugs).
•Use within 90 days before randomization of chronic (> 14 days) systemic glucocorticoid therapy (excluding topical, intraocular, intranasal, intraarticular, or inhaled preparations).
•Use within 90 days before randomization of medications that may cause significant weight gain including, but not limited to, atypical antipsychotic and mood stabilizers.
•Current or prior use of herbal supplements that affect insulin or glucose within 30 days before randomization.
•Currently receiving treatment in another investigational device or drug study, or less than 30 days (or 5 half-lives, whichever is longer) since ending treatment on another investigational device or drug study(ies).
•Participants of childbearing potential unwilling to adhere to contraception requirements during treatment and for an additional 16 weeks after the last dose of IMP.
•Participants who are breastfeeding or who plan to breastfeed while on study through 16 weeks after the last dose of IMP.
•Participants planning to become pregnant while on study through 16 weeks after the last dose of IMP.
•Major surgical procedure planned during the study.
•Participant has known sensitivity to any of the products or components to be administered during dosing.
•Participant likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required study procedures to the best of the participant and investigator's knowledge.
•History or evidence of any other clinically significant disorder, condition, or disease (except for those outlined above) that, in the opinion of the investigator or medical monitor, if consulted as necessary, would pose a risk to participant's safety or interfere with the study evaluation, procedures, or completion.

Endpoints (39)

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

Patient-reported / QoL
11
Glycemic / diabetes
10
Cardiometabolic biomarkers
6
Weight & body composition
5
Safety / tolerability / PK
3
Other (unclassified)
3
Other clinical outcomes
1

Weight & body composition

5 endpoints
Secondary/protocol endpoint

Change from Baseline in Percentage Body Fat at Week 25

Time frame:Baseline and Week 25

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Fat Mass at Week 25

Time frame:Baseline and Week 25

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Lean Body Mass at Week 25

Time frame:Baseline and Week 25

Lean mass

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Body Weight at Week 25

Time frame:Baseline and Week 25

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Waist Circumference at Week 25

Time frame:Baseline and Week 25

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

10 endpoints
Primary/protocol endpoint

Change from Baseline in M-value from Hyperinsulinemic-euglycemic Clamp at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Total Insulin Secretion at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in First Phase Incremental ISR from Hyperglycemic Clamp (ISR0-8min) at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Second Phase Insulin Secretion at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Maximum Insulin Secretion at 8 Minutes at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Maximum Insulin Secretion at 30 Minutes at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Clamp Disposition Index (cDI) at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Post-meal Glucose Concentrations During sMMTT (Total and Incremental AUC0-240min) at Week 25

Time frame:Baseline and Week 25

Postprandial glucose

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Hemoglobin A1c (HbA1c) at Week 25

Time frame:Baseline and Week 25

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change from Baseline in Fasting Glucose Concentration at Week 25

Time frame:Baseline and Week 25

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Cardiometabolic biomarkers

6 endpoints
Secondary/protocol endpoint

Change from Baseline in Fasting Triglycerides at Week 25

Time frame:Baseline and Week 25

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from Baseline in Fasting High-density Lipoprotein-cholesterol (HDL-C) at Week 25

Time frame:Baseline and Week 25

HDL-C, change

change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Change from Baseline in Fasting Non-HDL-C at Week 25

Time frame:Baseline and Week 25

Non-HDL cholesterol, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Triglyceride Concentration During sMMTT (Total and Incremental AUC0-240min) at Week 25

Time frame:Baseline and Week 25

Triglycerides, change

change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Change from Baseline in Fasting Free Fatty Acids (FFA) Concentration (During Hyperinsulinemic-euglycemic Clamp and sMMTT) at Week 25

Time frame:Baseline and Week 25

Free fatty acids, change

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in FFA Concentrations During sMMTT (Total AUC0-240min) at Week 25

Time frame:Baseline and Week 25

Free fatty acids, change

change from baseline, improvement

Patient-reported / QoL

11 endpoints
Secondary/protocol endpoint

Change from Baseline in Hunger Fasting Appetite Visual Analog Scale (VAS) Score at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Satiety Fasting Appetite VAS Score at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Fullness Fasting Appetite VAS Score at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Prospective Food Consumption Fasting Appetite VAS Score at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Overall Fasting Appetite VAS Score at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Hunger Appetite VAS Score During sMMTT at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Satiety Appetite VAS Score During sMMTT at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Fullness Appetite VAS Score During sMMTT at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Prospective Food Consumption Appetite VAS Score During sMMTT at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Overall Appetite VAS Score During sMMTT at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint

Change from Baseline in Food Craving Inventory (FCI) Score at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Safety / tolerability / PK

3 endpoints
Secondary/protocol endpoint

Number of Participants with Treatment-emergent Adverse Events and Serious Adverse Events

Time frame:Up to Week 41

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

Plasma Concentration of Maridebart Cafraglutide at Week 25

Time frame:Week 25

Plasma concentration (steady state)

concentration, descriptive

Secondary/protocol endpoint

Number of Participants with Anti-maridebart Cafraglutide Antibody Formation

Time frame:Up to Week 41

Immunogenicity (ADA)

threshold achievement, event

Other clinical outcomes

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Caloric Intake During Ad Libitum Meal at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Other (unclassified)

3 endpoints
Secondary/protocol endpoint/low confidence

Change from Baseline in ISR at Week 25

Time frame:Baseline and Week 25

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Change from Baseline in Fasting Glucagon Concentration at Week 25

Time frame:Baseline and Week 25

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Change from Baseline in Glucagon Concentration During sMMTT (Total and Incremental AUC0-240min) at Week 25

Time frame:Baseline and Week 25

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.