Nonalcoholic fatty liver disease study
Protocol: SITE00000084
Full Title
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide versus Placebo in Patients with Nonalcoholic Steatohepatitis (NASH)
Description
This study enrolls adults with nonalcoholic steatohepatitis (NASH). The purpose of this study is to learn about how much a medication called tirzepatide can help people with this condition.

You will be in this study for about a year and a half. You will take the study medication for 1 year and will have study visits and blood draws during while you are in the study. During the study you will take either different amounts of the investigational drug or a placebo. A placebo looks exactly like the investigational drug but does not have active medication in it. You will be randomly selected to be in a group, like picking a number from a hat. The chance that you will get any one of the study treatments is 1 in 4. Neither you or the study doctor will know which group you are in. The study visits take place in the Clinical and Translational Research Center, 875 Ellicott St. Buffalo, NY 14203 and/or Kaleida Health facilities.

Technical Description

(CSR # 190805142217) The study objective is to demonstrate that tirzepatide 5 mg, 10 mg or 15mg administered SC QW is superior to placebo for NASH resolution with no worsening of fibrosis at Week 52.
Secondary objective are: Regression of fibrosis with no worsening of NASH. Prevention of fibrosis progression. Decreasing NAS by ?2 points. Decreasing liver fat content. Decreasing body weight.
Compensation: Yes
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Compensation may include cash, checks, gift cards, debit cards, or incentives like gift baskets, technology items, or merchandise.
Eligibility
Adults ages 18-80.
Overweight or obese.
Diagnosis of NASH by liver biopsy in the past 6 months.
Have fibrosis stage 2 or 3.
Age Group: Adults
Principal Investigator: ANDREW TALAL
Contact(s)
JENNA SUNDERLIN
jls39@buffalo.edu
+1 716-888-4842
Want to Learn More?
Let us know how the study team can reach you. If you do not hear back within 2 business days, reach out to the study team directly at the contact information above or email ctsiresearch@buffalo.edu and someone will assist you.