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

NCT06660173
clinicaltrials.gov
Phase
Phase 2
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Recruitment status
Active, not recruiting
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Participants
409
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Lead sponsor
Amgen
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Start date
2024-11-07
clinicaltrials.gov
Number of sites
96
clinicaltrials.gov

Summary
The main purpose of this study is to assess the dose-response relationship of maridebart cafraglutide on glucose control compared with placebo.
clinicaltrials.gov
Short title
A Study of Maridebart Cafraglutide in Adult Participants With Type 2 Diabetes Mellitus (T2DM)
clinicaltrials.gov
Official title
A Study to Evaluate the Efficacy, Safety & Tolerability of Maridebart Cafraglutide in Adults With T2DM
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Control arm
Placebo
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2026-11-10
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First posted
2024-10-28
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Registry last updated
2025-11-25
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Primary completion date
2025-10-06
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Start date
2024-11-07
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Actual participants
409
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Participants
409
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Participant count basis
Actual
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Protocol amendments
4
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Number of sites
96
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Amgen
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Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06660173
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06660173
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

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

    Timeframe: Baseline to Week 24

  1. Percent Change From Baseline to Week 24 in Body Weight

    Timeframe: Baseline to Week 24

  2. Number of Participants Achieving HbA1c < 7.0% at Week 24

    Timeframe: Week 24

  3. Number of Participants Achieving HbA1c ≤ 6.5% at Week 24

    Timeframe: Week 24

  4. Number of Participants Achieving ≥ 5% Reduction in Body Weight From Baseline at Week 24

    Timeframe: Week 24

  5. Number of Participants Achieving ≥ 10% Reduction in Body Weight From Baseline at Week 24

    Timeframe: Week 24

  6. Change From Baseline to Week 24 in Fasting Glucose

    Timeframe: Baseline to Week 24

  7. Percent Change From Baseline to Week 24 in Total Cholesterol

    Timeframe: Baseline to Week 24

  8. Percent Change From Baseline to Week 24 in Low-density Lipoprotein Cholesterol (LDL-C)

    Timeframe: Baseline to Week 24

  9. Percent Change From Baseline to Week 24 in High-density Lipoprotein Cholesterol (HDL-C)

    Timeframe: Baseline to Week 24

  10. Percent Change From Baseline to Week 24 in Non-high Density Lipoprotein Cholesterol (non-HDL-C)

    Timeframe: Baseline to Week 24

  11. Percent Change From Baseline to Week 24 in Very-low-density Lipoprotein Cholesterol (VLDL-C)

    Timeframe: Baseline to Week 24

  12. Percent Change From Baseline to Week 24 in Triglycerides

    Timeframe: Baseline to Week 24

  13. Percent Change From Baseline to Week 24 in Free Fatty Acids (FFA)

    Timeframe: Baseline and Week 24

  14. Change From Baseline to Week 24 in Systolic Blood Pressure

    Timeframe: Baseline and Week 24

  15. Change From Baseline to Week 24 in Diastolic Blood Pressure

    Timeframe: Baseline and Week 24

  16. Change from Baseline to Week 24 in High-sensitivity C-reactive Protein

    Timeframe: Baseline and Week 24

  17. Pre-dose Plasma Concentration of Maridebart Cafraglutide at Week 20

    Timeframe: Week 20

  18. Maximum Observed Plasma Concentration of Maridebart Cafraglutide at Week 20

    Timeframe: Week 20

  19. Number of Participants with Treatment Emergent Adverse Events

    Timeframe: Up to 24 Weeks

  20. Number of Participants with Serious Adverse Events

    Timeframe: Up to 24 Weeks

  21. Number of Participants with Anti-maridebart Cafraglutide Antibody Formation

    Timeframe: Up to Week 24

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  • 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

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Accel Research Site - Birmingham Clinical Research UnitBirmingham, United States
  • Anaheim Clinical TrialsAnaheim, United States
  • Hope Clinical Research LLCCanoga Park, United States
  • Orange County Research CenterLake Forest, United States
  • San Jose Clinical TrialsSan Jose, United States
  • Northeast Research Institute - NeriFleming Island, United States
  • New Horizon Research CenterMiami, United States
  • Florida Institute for Clinical ResearchOrlando, United States
  • Conquest Research - Winter ParkWinter Park, United States
  • Accel Research Site - NeurostudiesDecatur, United States
  • Cedar Crosse Research and Health CareChicago, United States
  • Tandem Clinical Research - MarreroMarrero, United States
  • DM Clinical - DetroitSouthfield, United States
  • Montana Medical ResearchMissoula, United States
  • Physicians EastGreenville, United States
  • Diabetes and Endocrinology Associates of Stark County IncCanton, United States
  • Alliance for Multispecialty ResearchNorman, United States
  • Trial Management Associates - Myrtle BeachMyrtle Beach, United States
  • FutureSearch Trials of NeurologyAustin, United States
  • Velocity Clinical Research - DallasDallas, United States
  • DM Clinical Research - Cyfair Clinical Research CenterHouston, United States
  • Southern Endocrinology Associates PAMesquite, United States
  • Be Well Clinical StudiesRound Rock, United States
  • Diabetes and Glandular Disease ClinicSan Antonio, United States
  • DM Clinical Research - Martin Diagnostic ClinicTomball, United States

And 71 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

Other registry identifiers

  • 2024-513539-25-00
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)