臨床研究等提出・公開システム

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

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

Hama Yoriko

Amgen K.K.

Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo

clinicaltrials_japan@amgen.com

Local Contact

Amgen K.K.

Midtown Tower 9-7-1 Akasaka, Minato-ku, Tokyo

+81-80-7217-8592

clinicaltrials_japan@amgen.com

Not Recruiting

Nov. 07, 2024

Interventional

randomized controlled trial

double blind

placebo control

parallel assignment

treatment purpose

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

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.

Both

Type 2 Diabetes Mellitus (T2DM)

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 main treatment period and meet specific criteria will have the option to begin an exploratory part 2 portion where they will be re-randomized to receive maridebart cafraglutide for an additional 24 weeks.
Interventions:
Drug: Maridebart Cafraglutide

Placebo Comparator: Placebo
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 main treatment period and meet specific criteria will have the option to begin an exploratory part 2 period where they will receive maridebart cafraglutide for an additional 24 weeks.
Interventions:
Drug: Placebo

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

1. Percent Change From Baseline to Week 24 in Body Weight [Time Frame: Baseline to Week 24]
2. Number of Participants Achieving HbA1c < 7.0% at Week 24 [Time Frame: Week 24]
3. Number of Participants Achieving HbA1c <= 6.5% at Week 24 [Time Frame: Week 24]
4. Number of Participants Achieving >= 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: Up to Week 24]

Sept. 13, 2024

Yes

De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.

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