Recruiting
A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)
I8F-MC-GPHR - ClinicalTrials.gov - NCT04166773
The purpose of this study is to see if the study drug, tirzepatide administered once weekly, is safe and effective as a treatment for Nonalcoholic Steatohepatitis (NASH).
How long will I be in the trial?
The study will last about 68 weeks and may include up to 15 visits.
Recruiting
A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)
I8F-MC-GPHR - ClinicalTrials.gov - NCT04166773
The purpose of this study is to see if the study drug, tirzepatide administered once weekly, is safe and effective as a treatment for Nonalcoholic Steatohepatitis (NASH).
How long will I be in the trial?
The study will last about 68 weeks and may include up to 15 visits.
Key Requirements
Age :
18-80
Sex:
All
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
18-80
Sex
All
Participants must
Participants must have a body mass index (BMI) ≥27 kilograms per square meter (kg/m²) and ≤50 kg/m² with stable body weight for at least 3 months
Participants with or without type 2 diabetes mellitus (T2DM). If the participant has T2DM, the hemoglobin A1c (HbA1c) ≤9.5%
Participants must be willing to undergo baseline and endpoint liver biopsies
Participants must have a liver biopsy that shows fatty liver with liver scarring
Participants must NOT
Participants must not have known or suspected alcohol abuse (>14 units/week for women and >21 units/week for men) or active substance abuse
Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 6 months
Participants must not have active cancer within the last 5 years
Participants must not have a diagnosis of type 1 diabetes
Participants must not have a history of inflammation of the pancreas
Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate birth control
Trial Summary
Conditions the trial is for
Liver Disease
What the trial is testing?
Tirzepatide, Placebo
Could I receive a Placebo?
yes
Enrollment Goal
196
Trial Dates
November 2019 - June 2022
Trial Phase
2
Enter your postal code to find the nearest site
Key Requirements
Use the following checklist to help determine if this trial may be a good fit for you. Place a checkmark next to each criteria that you successfully meet.
Age
18-80
Sex
All
Participants must
Participants must have a body mass index (BMI) ≥27 kilograms per square meter (kg/m²) and ≤50 kg/m² with stable body weight for at least 3 months
Participants with or without type 2 diabetes mellitus (T2DM). If the participant has T2DM, the hemoglobin A1c (HbA1c) ≤9.5%
Participants must be willing to undergo baseline and endpoint liver biopsies
Participants must have a liver biopsy that shows fatty liver with liver scarring
Participants must NOT
Participants must not have known or suspected alcohol abuse (>14 units/week for women and >21 units/week for men) or active substance abuse
Participants must not have heart attack, stroke, or hospitalization for congestive heart failure in the past 6 months
Participants must not have active cancer within the last 5 years
Participants must not have a diagnosis of type 1 diabetes
Participants must not have a history of inflammation of the pancreas
Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate birth control
Trial Summary
Conditions the trial is for
Liver Disease
What the trial is testing?
Tirzepatide, Placebo
Could I receive a Placebo?
yes
Enrollment Goal
196
Trial Dates
November 2019 - June 2022
Trial Phase
2
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Trial Locations
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