A Randomized Double-Blind Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide versus Placebo in Patients with Nonalcoholic Steatohepatitis (NASH)

Are you eligible to participate in this study?

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

  • Conditions:
    Non-alcoholic Steatohepatitis
  • Age: Between 18 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Body mass index (BMI) =27 kg/m2 and =50 kg/m2
    2. For participants with T2DM
      • Glycated haemoglobin test (HbA1c) =9.5% at time of screening
      • Treated with diet and/or exercise, or treated with oral antihyperglycemic medication
      • For participants treated with a DPP-4 inhibitor, the medication must be discontinued prior to randomization (as per the protocol)
    3. For participants without diagnosed T2DM:
      • Glycated haemoglobin test (HbA1c) <6.5% at time of screening
      • Fasting glucose <7.0 mmol/L (126 mg/dL)
    4. Participants diagnosed NASH by liver biopsy
    5. Stable body weight for at least 3 months.
    6. Participants currently treated with vitamin E (=400 IU QD) or TZDs for NASH need to remain on treatment during the study
    7. Participants with a documented history of Gilbert’s syndrome may be enrolled if the direct bilirubin is within normal reference range
    8. Participants, both men and women should use contraceptives as indicated on the protocol
    9. Participants willing and able to provide written informed consent

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

    1. Alcohol consumption >14 units/week for women and >21 units/week for men
    2. Participants with Fibrosis stages 0 and 1
    3. Cirrhosis (fibrosis stage 4)
    4. Participants with evidence of other forms of chronic liver disease
    5. Participants with clinical evidence of hepatic decompensation
    6. Inability to safely obtain a liver biopsy
    7. History of biliary diversion
    8. Participants known positive for human immunodeficiency virus infection
    9. Has active, serious medical disease with likely life expectancy <5 years
    10. Participants with active substance abuse including oral, inhaled or injection drugs in the year prior to screening
    11. Any current or historical condition that, in the opinion of the investigator, may preclude the participant from following and completing the protocol
    12. Uncontrolled Type 2 diabetes mellitus (T2DM)
    13. Type 1 diabetes mellitus (T1DM), latent autoimmune diabetes



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