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, NASH (Non-Alcoholic SteatoHepatitis)
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, NASH (Non-Alcoholic SteatoHepatitis)
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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