Current partner codePEPTIDESDE
NCT06660173·Phase 2·INTERVENTIONAL

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

Status

Active, not recruiting

Phase

Phase 2

Enrollment

409

Locations

96

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.

Interventions

Treatment arms and agents.

DRUG

Maridebart Cafraglutide

Solution for subcutaneous injection.

DRUG

Placebo

Solution for subcutaneous injection.

Timeline

From registration to results.

  1. First posted

    Oct 28, 2024

  2. Study start

    Nov 7, 2024

  3. Primary completion

    Oct 6, 2025

  4. Study completion

    Nov 10, 2026

  5. Results posted

    Not reported

  6. Registry updated

    Nov 25, 2025

Outcomes

What the study measures.

Primary outcomes

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

Time frame · Baseline to Week 24

Secondary outcomes

Percent Change From Baseline to Week 24 in Body Weight

Time frame · Baseline to Week 24

Number of Participants Achieving HbA1c < 7.0% at Week 24

Time frame · Week 24

Number of Participants Achieving HbA1c ≤ 6.5% at Week 24

Time frame · Week 24

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

Time frame · Week 24

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

Time frame · Week 24

Change From Baseline to Week 24 in Fasting Glucose

Time frame · Baseline to Week 24

Percent Change From Baseline to Week 24 in Total Cholesterol

Time frame · Baseline to Week 24

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

Time frame · Baseline to Week 24

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

Time frame · Baseline to Week 24

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

Time frame · Baseline to Week 24

Eligibility

Who can take part.

Minimum age
18 Years
Maximum age
Not reported
Sex
ALL
Healthy volunteers
No

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.

Study locations

96 registered sites.

Austria · Greece · Hong Kong · Hungary · Italy · Japan · Poland · Puerto Rico · Romania · South Korea · Spain · Sweden · Taiwan · United States. Showing up to 24 locations stored in the fast local snapshot.

Accel Research Site - Birmingham Clinical Research Unit

Birmingham, Alabama, United States

Anaheim Clinical Trials

Anaheim, California, United States

Hope Clinical Research LLC

Canoga Park, California, United States

Orange County Research Center

Lake Forest, California, United States

San Jose Clinical Trials

San Jose, California, United States

Northeast Research Institute - Neri

Fleming Island, Florida, United States

New Horizon Research Center

Miami, Florida, United States

Florida Institute for Clinical Research

Orlando, Florida, United States

Conquest Research - Winter Park

Winter Park, Florida, United States

Accel Research Site - Neurostudies

Decatur, Georgia, United States

Cedar Crosse Research and Health Care

Chicago, Illinois, United States

Tandem Clinical Research - Marrero

Marrero, Louisiana, United States

DM Clinical - Detroit

Southfield, Michigan, United States

Montana Medical Research

Missoula, Montana, United States

Physicians East

Greenville, North Carolina, United States

Diabetes and Endocrinology Associates of Stark County Inc

Canton, Ohio, United States

Alliance for Multispecialty Research

Norman, Oklahoma, United States

Trial Management Associates - Myrtle Beach

Myrtle Beach, South Carolina, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

Velocity Clinical Research - Dallas

Dallas, Texas, United States

DM Clinical Research - Cyfair Clinical Research Center

Houston, Texas, United States

Southern Endocrinology Associates PA

Mesquite, Texas, United States

Be Well Clinical Studies

Round Rock, Texas, United States

Diabetes and Glandular Disease Clinic

San Antonio, Texas, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Maridebart cafraglutide.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.