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Recruitment Complete
Sponsor ID
20230143

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

Sponsor ID
20230143
Clinicaltrials.gov ID
NCT06660173
EUCTIS ID
2024-513539-25-00
EudraCT ID
N/A
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Study Details

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

Additional Study Details

Phase
Phase 2
Product
Maridebart Cafraglutide
Type
Interventional
Masking
Double (Participant, Investigator)
Enrollment
409
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Timeframe: Baseline to Week 24

Secondary Outcome Measures

Percent Change From Baseline to Week 24 in Body Weight

Timeframe: Baseline to Week 24

Number of Participants Achieving HbA1c < 7.0% at Week 24

Timeframe: Week 24

Number of Participants Achieving HbA1c ≤ 6.5% at Week 24

Timeframe: Week 24

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

Timeframe: Week 24

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

Timeframe: Week 24

Change From Baseline to Week 24 in Fasting Glucose

Timeframe: Baseline to Week 24

Percent Change From Baseline to Week 24 in Total Cholesterol

Timeframe: Baseline to Week 24

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

Timeframe: Baseline to Week 24

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

Timeframe: Baseline to Week 24

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

Timeframe: Baseline to Week 24

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

Timeframe: Baseline to Week 24

Percent Change From Baseline to Week 24 in Triglycerides

Timeframe: Baseline to Week 24

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

Timeframe: Baseline and Week 24

Change From Baseline to Week 24 in Systolic Blood Pressure

Timeframe: Baseline and Week 24

Change From Baseline to Week 24 in Diastolic Blood Pressure

Timeframe: Baseline and Week 24

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

Timeframe: Baseline and Week 24

Pre-dose Plasma Concentration of Maridebart Cafraglutide at Week 20

Timeframe: Week 20

Maximum Observed Plasma Concentration of Maridebart Cafraglutide at Week 20

Timeframe: Week 20

Number of Participants with Treatment Emergent Adverse Events

Timeframe: Up to 24 Weeks

Number of Participants with Serious Adverse Events

Timeframe: Up to 24 Weeks

Number of Participants with Anti-maridebart Cafraglutide Antibody Formation

Timeframe: Up to Week 24

Locations

Location
Status
Contact Us
Location
Athens Medical Center- Iatriko Paleou Falirou
Palaio Faliro, Greece, 17562
Status
Recruiting
Location
Thermi Clinic S.A.
Thessaloniki, Greece, 57001
Status
Recruiting
Location
Athens Medical Center S.A - Iatriko Amarousiou
Maroussi, Greece, 15125
Status
Recruiting
Location
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary, 4032
Status
Recruiting
Location
Nakamoto Medical Clinic
Mito-shi, Ibaraki, Japan, 310-0826
Status
Recruiting
Location
Ohishi Naika Clinic
Tsuchiura-shi, Ibaraki, Japan, 300-0835
Status
Recruiting
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Study Info
Age
18+ years
Condition
  • Diabetes
    • Sex
    All
    Trial Dates
    Nov 2024 - Oct 2025
    Inclusion and Exclusion Criteria
    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.