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Evaluating Efficacy and Safety of Maridebart Cafraglutide in Adults Living With Elevated Liver Fat a

  • Status
    Accepting Candidates
  • Age
    18 Years - 99 Years
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

The main objective of this trial will be to determine whether maridebart cafraglutide is superior to placebo on reduction in liver fat content and body weight in participants living with obesity or overweight and elevated liver fat content, when administered in conjunction with reduced-calorie diet and increased physical activity.

Details

Full study title Amgen Inc. Phase 2b Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Maridebart Cafraglutide in Adult Participants Living With Elevated Liver Fat and Obesity or Overweight
Protocol number OCR49330
ClinicalTrials.gov ID NCT07441252
Phase Phase 2

Eligibility

Inclusion Criteria:

  • Age ≥ 18 years.

  • Body Mass index (BMI) ≥ 27 kg/m^2 to ≤ 40 kg/m^2 at screening.

  • For participants with type 2 diabetes mellitus (T2DM) at screening:

  • HbA1c ≤ 9.5% (80 mmol/mol) at screening.

  • Treated with diet and exercise alone and/or a stable treatment with metformin, sodium-glucose cotransporter-2 (SGLT-2) inhibitors, or combination.

  • Liver Controlled Attenuation Parameter (CAPTM) ≥ 300 dB/meter via FibroScan® assessment.

  • Liver fat content ≥ 10% by MRI as determined by the central imaging vendor at screening.

  • MRI assessment should only be performed after all other eligibility has been confirmed whenever possible.

  • History of at least 1 self-reported unsuccessful attempt at weight loss by diet and exercise.

Exclusion Criteria:

  • Recent or planned surgical/device-based obesity treatment (

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  1. Step
    1

    Contact the research team

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    Primary contact

  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
    3

    Provide your consent to participate

    If you are eligible and want to join the clinical trial or study, a member of the research team will ask for your consent to participate. To give consent, you will be asked to read and sign a consent form for the study. This consent form explains the study's purpose, procedures, risks, benefits and provides other important information, such as the study team's contact information.

  4. Step
    4

    Participate

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