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

Amgen

Status and phase: Enrolling; Phase 2

Conditions: Type 2 Diabetes Mellitus (T2DM)

Treatments: Drug: Maridebart Cafraglutide; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT06660173

20230143

Details and patient eligibility

About

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

Enrollment: 350 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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350 participants in 2 patient groups, including a placebo group

Maridebart Cafraglutide

Experimental group

Description:

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.

Treatment:

Drug: Maridebart Cafraglutide

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo