Recruiting

A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH) (SYNERGY-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.
Email
Recruiting

A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH) (SYNERGY-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.
Email

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 - December 2023

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 - December 2023

Trial Phase

2

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Resources

Clinical Trial Participation: What to Expect

Clinical Trial Participation: What to Expect

A clinical trial is a scientific study in people that helps to determine if and how a drug or therapy works. These can also be called clinical studies, or clinical research. Clinical research helps us answer specific questions about an investigational drug , such as: Is it effective? Is it more effective than another established treatment? Is it safe and/or what are its side effects?