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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031240561

Enrollment

350

Registered

2024-12-16

Start date

2024-11-07

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus (T2DM)

Interventions

Experimental: Maridebart Cafraglutide Participants will be randomized to receive maridebart cafraglutide at varying dose levels, or placebo, for up to 24 weeks. Participants who complete the 24-week m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age >= 18 years at screening (or >= legal age within the country if it is older than 18 years) 2. Type 2 diabetes for >= 6 months according to the World Health Organization classification 3. HbA1c of 7.0% to 10.5%, inclusive, as assessed by the central laboratory 4. 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 5. Body mass index of 23 to 50 kilograms per square meter

Exclusion criteria

Exclusion criteria: 1. Type 1 diabetes 2. Use of any glucose-lowering medication, other than metformin with or without a sodium-glucose cotransporter-2 inhibitor, within 3 months prior to screening 3. Estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 square meter, calculated by the Chronic Kidney Disease-Epidemiology equation. 4. Uncontrolled and potentially unstable diabetic retinopathy or maculopathy 5. History of acute or chronic pancreatitis 6. Malignancy within 5 years before screening, except for nonmelanoma skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer 7. 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. 8. Use of medications that affect glucose control or body weight or history of bariatric surgery or procedures.

Design outcomes

Primary

Measure	Time frame
1.Change From Baseline to Week 24 in Hemoglobin A1c (HbA1c) [Time Frame: Baseline to Week 24]	—

Secondary

Measure	Time frame
1. Percent Change From Baseline to Week 24 in Body Weight [Time Frame: Baseline to Week 24] 2. Number of Participants Achieving HbA1c = 5% Reduction in Body Weight From Baseline at Week 24 [Time Frame: Week 24] 5. Number of Participants Achieving >= 10% Reduction in Body Weight From Baseline at Week 24 [Time Frame: Week 24] 6. Change From Baseline to Week 24 in Fasting Glucose [Time Frame: Baseline to Week 24] 7. Percent Change From Baseline to Week 24 in Total Cholesterol [Time Frame: Baseline to Week 24] 8. Percent Change From Baseline to Week 24 in Low-density Lipoprotein Cholesterol (LDL-C) [Time Frame: Baseline to Week 24] 9. Percent Change From Baseline to Week 24 in High-density Lipoprotein Cholesterol (HDL-C) [Time Frame: Baseline to Week 24] 10. Percent Change From Baseline to Week 24 in Non-high Density Lipoprotein Cholesterol (non-HDL-C) [Time Frame: Baseline to Week 24] 11. Percent Change From Baseline to Week 24 in Very-low-density Lipoprotein Cholesterol (VLDL-C) [Time Frame: Baseline to Week 24] 12. Percent Change From Baseline to Week 24 in Triglycerides [Time Frame: Baseline to Week 24] 13. Percent Change From Baseline to Week 24 in Free Fatty Acids (FFA) [Time Frame: Baseline and Week 24] 14. Change From Baseline to Week 24 in Systolic Blood Pressure [Time Frame: Baseline and Week 24] 15. Change From Baseline to Week 24 in Diastolic Blood Pressure [Time Frame: Baseline and Week 24] 16. Change from Baseline to Week 24 in High-sensitivity C-reactive Protein [Time Frame: Baseline and Week 24] 17. Pre-dose Plasma Concentration of Maridebart Cafraglutide at Week 20 [Time Frame: Week 20] 18. Maximum Observed Plasma Concentration of Maridebart Cafraglutide at Week 20 [Time Frame: Week 20] 19. Number of Participants with Treatment Emergent Adverse Events [Time Frame: Up to 24 Weeks] 20. Number of Participants with Serious Adverse Events [Time Frame: Up to 24 Weeks] 21. Number of Participants with Anti-maridebart Cafraglutide Antibody Formation [Time Frame:	—

Measure

Time frame

1. Percent Change From Baseline to Week 24 in Body Weight [Time Frame: Baseline to Week 24] 2. Number of Participants Achieving HbA1c = 5% Reduction in Body Weight From Baseline at Week 24 [Time Frame: Week 24] 5. Number of Participants Achieving >= 10% Reduction in Body Weight From Baseline at Week 24 [Time Frame: Week 24] 6. Change From Baseline to Week 24 in Fasting Glucose [Time Frame: Baseline to Week 24] 7. Percent Change From Baseline to Week 24 in Total Cholesterol [Time Frame: Baseline to Week 24] 8. Percent Change From Baseline to Week 24 in Low-density Lipoprotein Cholesterol (LDL-C) [Time Frame: Baseline to Week 24] 9. Percent Change From Baseline to Week 24 in High-density Lipoprotein Cholesterol (HDL-C) [Time Frame: Baseline to Week 24] 10. Percent Change From Baseline to Week 24 in Non-high Density Lipoprotein Cholesterol (non-HDL-C) [Time Frame: Baseline to Week 24] 11. Percent Change From Baseline to Week 24 in Very-low-density Lipoprotein Cholesterol (VLDL-C) [Time Frame: Baseline to Week 24] 12. Percent Change From Baseline to Week 24 in Triglycerides [Time Frame: Baseline to Week 24] 13. Percent Change From Baseline to Week 24 in Free Fatty Acids (FFA) [Time Frame: Baseline and Week 24] 14. Change From Baseline to Week 24 in Systolic Blood Pressure [Time Frame: Baseline and Week 24] 15. Change From Baseline to Week 24 in Diastolic Blood Pressure [Time Frame: Baseline and Week 24] 16. Change from Baseline to Week 24 in High-sensitivity C-reactive Protein [Time Frame: Baseline and Week 24] 17. Pre-dose Plasma Concentration of Maridebart Cafraglutide at Week 20 [Time Frame: Week 20] 18. Maximum Observed Plasma Concentration of Maridebart Cafraglutide at Week 20 [Time Frame: Week 20] 19. Number of Participants with Treatment Emergent Adverse Events [Time Frame: Up to 24 Weeks] 20. Number of Participants with Serious Adverse Events [Time Frame: Up to 24 Weeks] 21. Number of Participants with Anti-maridebart Cafraglutide Antibody Formation [Time Frame:

—

Countries

Austria, Greece, Hong Kong, Hungary, Italy, Japan, Korea, Poland, Puerto Rico, Romania, Spain, Sweden, Taiwan, United States

Contacts

Public ContactContact Local

Amgen K.K.

clinicaltrials_japan@amgen.com+81-80-7217-8592

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026