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Active, Not Recruiting

NCT Number: NCT06660173

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Body Weight Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Medizinische Universitaet Graz, Graz, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Maridebart cafraglutide

Drug

Solution for subcutaneous injection.

Other names: AMG 133

Placebo

Drug

Solution for subcutaneous injection.

Primary outcomes

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

    Time frame: Baseline to Week 24

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 28, 2024
Registry last updated
Nov 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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