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

Primary Purpose

Nonalcoholic Steatohepatitis

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Tirzepatide
Placebo
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Nonalcoholic Steatohepatitis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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 with T2DM, hemoglobin A1c (HbA1c) ≤9.5%
  • Participants must be willing to undergo baseline and endpoint liver biopsies
  • Participants must have histologic diagnosis of NASH with stage 2 or 3 fibrosis by liver biopsy
  • 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 evidence of cirrhosis or other forms of liver disease
  • 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 uncontrolled high blood pressure
  • Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) <30 milliters/minute/1.73m²; for participants on metformin, eGFR <45 mL/min/1.73m²
  • Participants must not have a diagnosis of type 1 diabetes
  • Participants must not have a history of pancreatitis (acute or chronic)
  • Participants must not have calcitonin ≥35 nanograms per liter
  • Participant must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative)
  • Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)

Sites / Locations

  • University of Alabama-The Kirklin Clinic
  • Synexus Clinical Research US, Inc.
  • Fresno Clinical Research Center
  • National Research Institute - Huntington Park
  • Catalina Research Institute, LLC
  • Diabetes Medical Center of California
  • Velocity Clinical Research, Panorama City
  • Alliance Clinical Research, LLC
  • Inland Empire Clinical Trials, LLC
  • Excel Medical Clinical Trials
  • Alliance for Multispecialty Research, LLC
  • Research Centers of America ( Hollywood )
  • East Coast Institute for Research, LLC
  • IHS Health Research
  • Accel Research Sites - Maitland Clinical Research Unit
  • Panax Clinical Research
  • Clinical Pharmacology of Miami
  • The Center for Digestive Health
  • Synexus Clinical Research
  • Synexus Clinical Research
  • Indiana University Health Hospital
  • Iowa Diabetes and Endocrinology Research Center
  • Alliance for Multispecialty Research, LLC
  • Tandem Clinical Research
  • The National Diabetes & Obesity Research Institute
  • Southern Therapy and Advanced Research (STAR) LLC
  • Buffalo Clinical and Translational Research Center
  • Icahn School of Medicine at Mount Sinai
  • Diabetes & Endocrinology Consultants, PC
  • Geisinger Medical Center
  • WR-Clinsearch, LLC
  • Dallas Diabetes Research Center
  • Radiant Research - Dallas North
  • Liver Center of Texas, PLLC
  • Texoma Medical Center
  • American Research Corporation at Texas Liver Institute
  • Synexus Clinical Research US, Inc.
  • Endeavor Clinical Trials
  • National Clinical Research, Inc
  • Harborview Medical Center/University of Washington
  • Groupe Hospitalier Mutualiste Les Portes du Sud
  • Fondazione Policlinico Universitario Agostino Gemelli
  • Aichi Medical University Hospital
  • JCHO Hokkaido Hospital
  • National Hospital Organization Yokohama Medical Center
  • JADECOM Nara City Hospital
  • Hirakata kohsai Hospital
  • Osaka Saiseikai Suita hospital
  • Shimane University Hospital
  • Fukuwa Clinic
  • Fukuiken Saiseikai Hospital
  • Gifu Municipal Hospital
  • Kumamoto Shinto General Hospital
  • University Hospital,Kyoto Prefectural University of Medicine
  • Osaka City University Hospital
  • Saga University Hospital
  • Yamagata University Hospital
  • Phylasis Clinicas Research
  • Grupo Medico Camino Sc
  • Christus Muguerza Hospital Sur
  • Synexus Polska Sp. z o.o. Oddzial w Warszawie
  • Synexus Polska Oddział w Lodzi
  • Instituto de Ciencias Médicas
  • Queen Elizabeth Hospital Birmingham
  • Synexus North East Clinical Research Centre
  • St. George's Hospital
  • Synexus Clinical Research Centre - Lancashire
  • King's College Hospital
  • Synexus North Teesside Clinical Research Centre
  • Synexus Midlands Clinical Research Centre
  • Aintree University Hospital NHS Foundation Trust
  • Synexus Manchester Clinical Research Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

5 mg Tirzepatide

10 mg Tirzepatide

15 mg Tirzepatide

Placebo

Arm Description

5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.

10 mg tirzepatide administered SC once a week.

15 mg tirzepatide administered SC once a week.

Placebo administered SC once a week.

Outcomes

Primary Outcome Measures

Percentage of Participants with Absence of NASH with no Worsening of Fibrosis on Liver Histology
Percentage of Participants with Absence of NASH with no Worsening of Fibrosis on Liver Histology

Secondary Outcome Measures

Percentage of Participants with ≥1 Point Decrease in Fibrosis Stage with No Worsening of NASH on Liver Histology
Percentage of Participants with ≥1 Point Decrease in Fibrosis Stage with No Worsening of NASH on Liver Histology
Percentage of Participants with ≥1 Point Increase in Fibrosis Stage on Liver Histology
Percentage of Participants with ≥1 Point Increase in Fibrosis Stage on Liver Histology
Percentage of Participants that Achieve a ≥2 Point Decrease in NAFLD (non-alcoholic fatty liver disease) Activity Score (NAS) on Liver Histology, with ≥1 Point Reduction in at Least 2 NAS Components
Percentage of Participants that Achieve a ≥2 Point Decrease in NAS on Liver Histology, with ≥1 Point Reduction in at Least 2 NAS Components
Mean Absolute Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Mean Absolute Change from Baseline in Liver Fat Content by MRI-PDFF
Mean Change from Baseline in Body Weight
Mean Change from Baseline in Body Weight

Full Information

First Posted
November 15, 2019
Last Updated
October 19, 2023
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT04166773
Brief Title
A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)
Acronym
SYNERGY-NASH
Official 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)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 19, 2019 (Actual)
Primary Completion Date
January 10, 2024 (Anticipated)
Study Completion Date
February 7, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonalcoholic Steatohepatitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
196 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
5 mg Tirzepatide
Arm Type
Experimental
Arm Description
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Arm Title
10 mg Tirzepatide
Arm Type
Experimental
Arm Description
10 mg tirzepatide administered SC once a week.
Arm Title
15 mg Tirzepatide
Arm Type
Experimental
Arm Description
15 mg tirzepatide administered SC once a week.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered SC once a week.
Intervention Type
Drug
Intervention Name(s)
Tirzepatide
Other Intervention Name(s)
LY3298176
Intervention Description
Administered SC
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Administered SC
Primary Outcome Measure Information:
Title
Percentage of Participants with Absence of NASH with no Worsening of Fibrosis on Liver Histology
Description
Percentage of Participants with Absence of NASH with no Worsening of Fibrosis on Liver Histology
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Percentage of Participants with ≥1 Point Decrease in Fibrosis Stage with No Worsening of NASH on Liver Histology
Description
Percentage of Participants with ≥1 Point Decrease in Fibrosis Stage with No Worsening of NASH on Liver Histology
Time Frame
Week 52
Title
Percentage of Participants with ≥1 Point Increase in Fibrosis Stage on Liver Histology
Description
Percentage of Participants with ≥1 Point Increase in Fibrosis Stage on Liver Histology
Time Frame
Week 52
Title
Percentage of Participants that Achieve a ≥2 Point Decrease in NAFLD (non-alcoholic fatty liver disease) Activity Score (NAS) on Liver Histology, with ≥1 Point Reduction in at Least 2 NAS Components
Description
Percentage of Participants that Achieve a ≥2 Point Decrease in NAS on Liver Histology, with ≥1 Point Reduction in at Least 2 NAS Components
Time Frame
Week 52
Title
Mean Absolute Change from Baseline in Liver Fat Content by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF)
Description
Mean Absolute Change from Baseline in Liver Fat Content by MRI-PDFF
Time Frame
Baseline, Week 52
Title
Mean Change from Baseline in Body Weight
Description
Mean Change from Baseline in Body Weight
Time Frame
Baseline, Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 with T2DM, hemoglobin A1c (HbA1c) ≤9.5% Participants must be willing to undergo baseline and endpoint liver biopsies Participants must have histologic diagnosis of NASH with stage 2 or 3 fibrosis by liver biopsy 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 evidence of cirrhosis or other forms of liver disease 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 uncontrolled high blood pressure Participants must not have renal impairment with estimated glomerular filtration rate (eGFR) <30 milliters/minute/1.73m²; for participants on metformin, eGFR <45 mL/min/1.73m² Participants must not have a diagnosis of type 1 diabetes Participants must not have a history of pancreatitis (acute or chronic) Participants must not have calcitonin ≥35 nanograms per liter Participant must not have family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma (family is defined as a first degree relative) Female participants must not be pregnant, breast-feeding, or intend to become pregnant or of childbearing potential and not using adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama-The Kirklin Clinic
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Fresno Clinical Research Center
City
Fresno
State/Province
California
ZIP/Postal Code
93720
Country
United States
Facility Name
National Research Institute - Huntington Park
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Catalina Research Institute, LLC
City
Montclair
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
Diabetes Medical Center of California
City
Northridge
State/Province
California
ZIP/Postal Code
91325
Country
United States
Facility Name
Velocity Clinical Research, Panorama City
City
Panorama City
State/Province
California
ZIP/Postal Code
91402
Country
United States
Facility Name
Alliance Clinical Research, LLC
City
Poway
State/Province
California
ZIP/Postal Code
90264
Country
United States
Facility Name
Inland Empire Clinical Trials, LLC
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Excel Medical Clinical Trials
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33434
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33134
Country
United States
Facility Name
Research Centers of America ( Hollywood )
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
East Coast Institute for Research, LLC
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
IHS Health Research
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Accel Research Sites - Maitland Clinical Research Unit
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
Panax Clinical Research
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
Clinical Pharmacology of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
Facility Name
The Center for Digestive Health
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Synexus Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Synexus Clinical Research
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Facility Name
Indiana University Health Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Iowa Diabetes and Endocrinology Research Center
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50265
Country
United States
Facility Name
Alliance for Multispecialty Research, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Tandem Clinical Research
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Facility Name
The National Diabetes & Obesity Research Institute
City
Biloxi
State/Province
Mississippi
ZIP/Postal Code
39532
Country
United States
Facility Name
Southern Therapy and Advanced Research (STAR) LLC
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Buffalo Clinical and Translational Research Center
City
Buffalo
State/Province
New York
ZIP/Postal Code
14203
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Diabetes & Endocrinology Consultants, PC
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
WR-Clinsearch, LLC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Dallas Diabetes Research Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Radiant Research - Dallas North
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Liver Center of Texas, PLLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234-7858
Country
United States
Facility Name
Texoma Medical Center
City
Denison
State/Province
Texas
ZIP/Postal Code
75020
Country
United States
Facility Name
American Research Corporation at Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Synexus Clinical Research US, Inc.
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Endeavor Clinical Trials
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
National Clinical Research, Inc
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Harborview Medical Center/University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Groupe Hospitalier Mutualiste Les Portes du Sud
City
Vénissieux
State/Province
Rhône-Alpes
ZIP/Postal Code
69200
Country
France
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Aichi Medical University Hospital
City
Nagakute-shi
State/Province
Aichi-ken
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
JCHO Hokkaido Hospital
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
062-8618
Country
Japan
Facility Name
National Hospital Organization Yokohama Medical Center
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
2458575
Country
Japan
Facility Name
JADECOM Nara City Hospital
City
Nara-Shi
State/Province
Nara-Ken
ZIP/Postal Code
630-8305
Country
Japan
Facility Name
Hirakata kohsai Hospital
City
Higashi-cho, Hirakata-city
State/Province
Osaka
ZIP/Postal Code
573-0153
Country
Japan
Facility Name
Osaka Saiseikai Suita hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
564-0013
Country
Japan
Facility Name
Shimane University Hospital
City
Izumo
State/Province
Shimane
ZIP/Postal Code
693-0021
Country
Japan
Facility Name
Fukuwa Clinic
City
Chuo-ku
State/Province
Tokyo
ZIP/Postal Code
104-0031
Country
Japan
Facility Name
Fukuiken Saiseikai Hospital
City
Fukui
ZIP/Postal Code
918-8503
Country
Japan
Facility Name
Gifu Municipal Hospital
City
Gifu
ZIP/Postal Code
500-8323
Country
Japan
Facility Name
Kumamoto Shinto General Hospital
City
Kumamoto
ZIP/Postal Code
862-8655
Country
Japan
Facility Name
University Hospital,Kyoto Prefectural University of Medicine
City
Kyoto
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Saga University Hospital
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Yamagata University Hospital
City
Yamagata
ZIP/Postal Code
990-9585
Country
Japan
Facility Name
Phylasis Clinicas Research
City
Cuautitlan Izcalli
State/Province
Distrito Federal
ZIP/Postal Code
54769
Country
Mexico
Facility Name
Grupo Medico Camino Sc
City
Mexico City
State/Province
Distrito Federal
ZIP/Postal Code
3310
Country
Mexico
Facility Name
Christus Muguerza Hospital Sur
City
Monterrey
State/Province
Nuevo León
ZIP/Postal Code
64988
Country
Mexico
Facility Name
Synexus Polska Sp. z o.o. Oddzial w Warszawie
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
02-672
Country
Poland
Facility Name
Synexus Polska Oddział w Lodzi
City
Lodz
State/Province
Łódzkie
ZIP/Postal Code
90-127
Country
Poland
Facility Name
Instituto de Ciencias Médicas
City
Alicante
ZIP/Postal Code
3004
Country
Spain
Facility Name
Queen Elizabeth Hospital Birmingham
City
Birmingham
State/Province
England
ZIP/Postal Code
B15 2TH
Country
United Kingdom
Facility Name
Synexus North East Clinical Research Centre
City
Hexham
State/Province
England
ZIP/Postal Code
NE46 1QJ
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Synexus Clinical Research Centre - Lancashire
City
Chorley
State/Province
Lancashire
ZIP/Postal Code
PR7 7NA
Country
United Kingdom
Facility Name
King's College Hospital
City
London
State/Province
London, City Of
ZIP/Postal Code
SE5 9RL
Country
United Kingdom
Facility Name
Synexus North Teesside Clinical Research Centre
City
Stockton on Tees
State/Province
Stockton-on-Tees
ZIP/Postal Code
TS19 8PE
Country
United Kingdom
Facility Name
Synexus Midlands Clinical Research Centre
City
Birmingham
ZIP/Postal Code
B15 2SQ
Country
United Kingdom
Facility Name
Aintree University Hospital NHS Foundation Trust
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Synexus Manchester Clinical Research Centre
City
Manchester
ZIP/Postal Code
M15 6SX
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
IPD Sharing Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
IPD Sharing Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
IPD Sharing URL
http://vivli.org/
Links:
URL
https://trials.lillytrialguide.com/en-US/trial/3lQTuBFU3GBu9vi4SAlDDp
Description
A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)

Learn more about this trial

A Study of Tirzepatide (LY3298176) in Participants With Nonalcoholic Steatohepatitis (NASH)

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