A Phase 2b Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of MK-3655 in Individuals With Pre-cirrhotic Nonalcoholic Steatohepatitis

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Nonalcoholic Steatohepatitis
  • Age: Between 18 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Has histological confirmation of NASH based on a liver biopsy obtained <= 6 months before Visit 1/Screening.
    2. Has a baseline MELD-Na score <= 12 at Visit 1/Screening
    3. Has a BMI>= 25 kg/m2 and <= 50 kg/m2
    4. Has stable weight (based on self-reporting) defined as =5% gain or loss of body weight for at least 3 months before Visit 1/Screening
    5. Has no history of T2DM. OR Has a history of T2DM with an A1C =9.5% at Visit 1/Screening and controlled by diet or stable doses of AHAs
    6. Has a systolic blood pressure of =160 mm Hg and a diastolic blood pressure =90 mm Hg
    7. Be willing and able to comply with scheduled visits, treatment plan, laboratory tests, and/or other study procedures
    8. Participants uses a contraceptive method that is highly effective according to the protocol
    9. Able to provide written informed consent

You may not be eligible for this study if the following are true:

    1. Has presence of cirrhosis on liver biopsy
    2. Has Type 1 diabetes
    3. Has a history of malignancy, unless cancer free >=5 years, or is under evaluation for active or suspected malignancy, except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
    4. Has a history of bariatric surgery <= 5 years before Visit 1/Screening
    5. Has undergone a major surgical procedure <=3 months before signing the ICF or has major surgery planned during the study.
    6. Has a history or evidence of:
      • Chronic liver disease other than NASH
      • Hepatitis B or Hepatitis C
      • Drug-induced liver disease
      • Ongoing autoimmune liver disease
      • Decompensated liver disease
      • HIV
      • Primary biliary cirrhosis (cholangitis)
      • Primary sclerosing cholangitis
      • Reye Syndrome
      • Splenomegaly
      • Wilson’s disease
      • Documented Cushing disease, Cushing syndrome, or any condition associated with hypercortisolism
      • Hyperthyroidism or Hypothyroidism
      • Alpha-1-antitrypsin deficiency
      • Hemochromatosis or iron overload
      • Spontaneous bacterial peritonitis
      • Known bile duct obstruction
      • Hepatocellular carcinoma
      • Untreated obstructive sleep apnea
      • Hemostasis disorder
    7. Has significant systemic or major illnesses other than liver disease, including recent events of congestive heart failure, unstable coronary artery disease, arterial revascularization, pulmonary disease, renal failure, stroke, transient ischemic attack, or organ transplantation.
    8. Has a known hypersensitivity to any of the ingredients or excipients of the IMP
    9. Has experienced any bone trauma, fracture, or bone surgery =2 months before Visit 1/Screening
    10. Has a history of osteoporosis
    11. Has an inability to reliably quantify alcohol consumption
    12. Has a recent history of drug abuse
    13. Has a known psychiatric or any other cognitive disorder
    14. Is at imminent risk of self-harm, based on clinical interview and responses on the C-SSRS, or of harm to others

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