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NCT06660173 | NOT YET RECRUITING | Type 2 Diabetes Mellitus (T2DM)

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

Amgen

Brief Summary:

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

Condition or disease

Type 2 Diabetes Mellitus (T2DM)

Intervention/treatment

Maridebart Cafraglutide

Placebo

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 350 participants
Masking : DOUBLE
Primary Purpose : TREATMENT
Official Title : A Study to Evaluate the Efficacy, Safety, and Tolerability of Maridebart Cafraglutide in Adult Subjects With T2DM
Actual Study Start Date : 2024-11-21
Estimated Primary Completion Date : 2025-11-05
Estimated Study Completion Date : 2026-07-22

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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
A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)

Location Details

NCT06660173

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How to Participate

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Locations

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