A Study of the Effectiveness and Safety of Subcutaneous Semaglutide for Patients with Fatty-Liver Disease, not Caused by Alcoholism


About this study

The purpose of this study is to investigate the effectiveness and safety of three dose levels of subcutaneous semaglutide for the treatment of patients who have fatty-liver disease not caused by alcoholism.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Informed consent obtained before any trial-related activities, ie. any procedures carried out as part of the trial, including to determine suitability for the trial
  • Male or female
  • Age 18-75 years inclusive (for Japan age 20-75 years  inclusive) at the time of signing informed consent
  • Local histological diagnosis of NASH followed by histological confirmation of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening
  • A histological NAS equal or above 4 with a score of 1 or more in each sub-component of the score based on central pathologist evaluation
  • NASH fibrosis stage 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation

Exclusion Criteria

  • Known or suspected abuse of alcohol (above 20 g/day for women or above 30 g/day for men), alcohol dependence as assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire), or narcotics use
  • Diagnosis of type 1 diabetes according to medical records
  • HbA1c above 9% at screening
  • History or presence of pancreatitis (acute or chronic)
  • Calcitonin equal or above 50 ng/L at screening
  • Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma
    • Family is defined as a first degree relative
  • Body Mass Index (BMI) equal or below 25.0 or equal or above 45.0 kg/m^2 at the screening visit
  • Pregnant, breast-feeding, intending to become pregnant, or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Rita Basu, M.D.

Closed for enrollment

More information


Publications are currently not available

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