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Clinical Studies


  • A Longitudinal Observational Study of Patients with Nonalcoholic Steatohepatitis (NASH) and Related Conditions Across the Entire Spectrum of Nonalcoholic Fatty Liver Disease (NAFLD) (TARGET) Rochester, Minn.

    TARGET-NASH is a longitudinal observational cohort study of patients being managed for NAFLD or NASH in usual clinical practice. TARGET-NASH will create a research registry of patients with NAFLD or NASH within academic and community real-world practices in order to assess the safety and effectiveness of current and future therapies.

  • A Phase 2, Randomized, Double-blind, Double-dummy, Placebo-controlled, Dose-ranging, Dose-finding, Parallel Group Study to Assess Efficacy and Safety of PF-06865571 (DGAT21) Alone and When Co-administered with PF-05221304 (ACCI) in Adult Participants with Biopsy-confirmed Nonalcoholic Steatohepatitis and Fibrosis Stage 2 or 3 (MIRNA) Jacksonville, Fla., Rochester, Minn. The study aims to evaluate two, orally administered, investigational agents - PF-06865571 (DGAT2 inhibitor) and the coadministration of PF-06865571 with PF-05221304 (ACC inhibitor). This study is specifically designed to evaluate the effect of a range of doses of DGAT2i alone, and DGAT2i + ACCi, on resolution of NASH or improvement in liver fibrosis, as assessed histologically (via liver biopsy).
  • The Effect of Semaglutide in Subjects with Non-cirrhotic, Non-alcoholic Steatohepatitis (Essence) Rochester, Minn.

    The primary objective for PART 1 of this study is to demonstrate that treatment with semaglutide s.c. 2.4 mg improves liver histology compared to placebo in subjects with NASH and fibrosis stage 2 or 3.

    The primary objective for PART 2 of this study is to demonstrate that treatment with semaglutide s.c. 2.4 mg lowers the risk of liver-related clinical events compared to placebo in subjects with NASH and fibrosis stage 2 or 3.

  • The Olmsted NAFLD Epidemiology Study (TONES) (Tones) Rochester, Minn.

    About this study

    Nonalcoholic fatty liver disease (NAFLD) is the most common cause of chronic liver disease in the world and a major public health issue in the US. It is estimated to affect 1 in 4 adults and it is most commonly found in people who are overweight or obese. Because it is a silent disease (without symptoms until end stage) and the lab tests can be normal, it can be missed in early stages. The fat in the liver can lead to inflammation and eventually scar deposition, which can progress to cirrhosis, liver cancer and need for liver transplantation.

    This study aims to assess how common this disease is in Olmsted County, what markers can identify the disease early to prevent progression to cirrhosis and what other medical problems occur in people with NAFLD in addition to the liver complications. We plan to enroll a large number of adults, assess their liver with state-of-the-art tests available at Mayo Clinic and follow them over several years to monitor for disease progression and other health complications. The ultimate goal of the study is to identify new markers that predict presence of fatty liver and poor health outcomes, in order to improve population health in the community.

    Participation eligibility

    Participants will be identified from the Olmsted County population age 18 or older.

    Inclusion criteria:

    1.         Adults age 18 years or older

    2.         Olmsted County residents at the time of study entry


    Exclusion criteria:

    1.         Pediatric population (age<18)

    2.         Unwilling to participate or unable to consent

    3.         Known liver disease other than NAFLD at the time of survey

    4.         Pregnant women

    5.         Alcohol use in excess (14 drinks or more per week for women and 21 drinks or more per week for men)

Closed for Enrollment