A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study Comparing the Efficacy and Safety of Tirzepatide Versus Placebo in Patients With Nonalcoholic Steatohepatitis (NASH)

Who is this study for? Patients with non-alcoholic steatohepatitis
What treatments are being studied? Tirzepatide
Status: Completed
Location: See all (112) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

⁃ 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)

Locations
United States
Alabama
University of Alabama-The Kirklin Clinic
Birmingham
Arizona
Synexus Clinical Research US, Inc.
Chandler
California
Fresno Clinical Research Center
Fresno
National Research Institute - Huntington Park
Huntington Park
UCSD - Altman Clinical and Translational Research Institute (ACTRI)
La Jolla
National Research Institute - Wilshire
Los Angeles
Catalina Research Institute, LLC
Montclair
Diabetes Medical Center of California
Northridge
Velocity Clinical Research, Panorama City
Panorama City
Inland Empire Clinical Trials, LLC
Rialto
Velocity Clinical Research, Santa Ana
Santa Ana
Florida
Excel Medical Clinical Trials
Boca Raton
Alliance for Multispecialty Research, LLC
Coral Gables
Research Centers of America ( Hollywood )
Hollywood
East Coast Institute for Research, LLC
Jacksonville
IHS Health Research
Kissimmee
Accel Research Sites - Maitland Clinical Research Unit
Maitland
Clinical Pharmacology of Miami
Miami
Synexus Clinical Research US, Inc.
Orlando
The Center for Digestive Health
Orlando
Synexus Clinical Research US, Inc.
The Villages
Iowa
Iowa Diabetes and Endocrinology Research Center
West Des Moines
Illinois
Synexus Clinical Research
Chicago
Indiana
Indiana University Health Hospital
Indianapolis
Kansas
Cotton O'Neil Clinical Research Center
Topeka
Alliance for Multispecialty Research, LLC
Wichita
Louisiana
Tandem Clinical Research
Marrero
Mississippi
The National Diabetes & Obesity Research Institute
Biloxi
Southern Therapy and Advanced Research (STAR) LLC
Jackson
North Carolina
Diabetes & Endocrinology Consultants, PC
Morehead City
New York
Buffalo Clinical and Translational Research Center
Buffalo
Icahn School of Medicine at Mount Sinai
New York
NYU Langone Health
New York
Montefiore Medical Center
The Bronx
Pennsylvania
Geisinger Medical Center
Danville
Tennessee
WR-Clinsearch, LLC
Chattanooga
Texas
Dallas Diabetes Research Center
Dallas
Liver Center of Texas, PLLC
Dallas
Radiant Research - Dallas North
Dallas
Texoma Medical Center
Denison
Texas Diabetes & Endocrinology, P.A.
Round Rock
American Research Corporation at Texas Liver Institute
San Antonio
Endeavor Clinical Trials
San Antonio
Synexus Clinical Research US, Inc.
San Antonio
Virginia
National Clinical Research, Inc
Richmond
Virginia Commonwealth University (VCU) Medical Center
Richmond
Washington
Harborview Medical Center/University of Washington
Seattle
Other Locations
Belgium
UZ Brussel
Brussels
Antwerp University Hospital
Edegem
UZ Gent
Ghent
UZ Leuven
Leuven
AZ Delta vzw
Roeselare
France
Centre Hospitalier Universitaire d'Angers
Angers
Centre Hospitalier Universitaire de Limoges - Hôpital Dupuytren
Limoges
Hôpital Saint Antoine
Paris
Pitie Salpetriere University Hospital
Paris
CHU Bordeaux Haut-Leveque
Pessac
Centre Hospitalier Lyon Sud
Pierre-bénite
Groupe Hospitalier Mutualiste Les Portes du Sud
Vénissieux
Israel
Carmel Hospital
Haifa
Rambam Health Care Campus
Haifa
Hadassah Medical Center
Jerusalem
Shaare Zedek Medical Center
Jerusalem
Galilee Medical Center
Nahariya
Sheba Medical Center
Ramat Gan
Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Di Foggia
Foggia
Ospedale Santa Maria Goretti
Latina
A.O.U. Policlinico Paolo Giaccone
Palermo
Fondazione Policlinico Universitario Agostino Gemelli
Roma
Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
Torino
Japan
Tokyo Medical And Dental University Medical Hospital
Bunkyō
Fukuiken Saiseikai Hospital
Fukui
Gifu Municipal Hospital
Gifu
Hirakata kohsai Hospital
Higashi-cho, Hirakata-city
Shimane University Hospital
Izumo
Kumamoto Shinto General Hospital
Kumamoto
University Hospital,Kyoto Prefectural University of Medicine
Kyoto
Aichi Medical University Hospital
Nagakute-shi
JADECOM Nara City Hospital
Nara
Niigata University Medical & Dental Hospital
Niigata
Saga University Hospital
Saga
JCHO Hokkaido Hospital
Sapporo
Osaka Saiseikai Suita hospital
Suita
Yamagata University Hospital
Yamagata
National Hospital Organization Yokohama Medical Center
Yokohama
Yokohama City University Hospital
Yokohama
Mexico
Centro de Investigación y Gastroenterología
Cuauhtémoc
Phylasis Clinicas Research
Cuautitlan Izcalli
Grupo Medico Camino Sc
Mexico City
Christus Muguerza Hospital Sur
Monterrey
Poland
Synexus Polska Oddział w Lodzi
Lodz
Synexus Polska Sp. z o.o. Oddzial w Warszawie
Warsaw
Spain
Instituto de Ciencias Médicas
Alicante
Hospital Universitario Puerta de Hierro Majadahonda
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Clínica Juaneda
Palma De Mallorca
Hospital Universitario Marqués de Valdecilla
Santander
Clínica nuevas Tecnologías en Diabetes y Endocrinología (NTDE)
Seville
Hospital Universitario Virgen Del Rocio
Seville
United Kingdom
Queen Elizabeth Hospital Birmingham
Birmingham
Synexus Midlands Clinical Research Centre
Birmingham
Synexus Clinical Research Centre - Lancashire
Chorley
John Radcliffe Hospital
Headington
Synexus North East Clinical Research Centre
Hexham
Aintree University Hospital NHS Foundation Trust
Liverpool
Imperial College London - St Mary's Hospital
London
King's College Hospital
London
Royal London Hospital
London
St. George's Hospital
London
Synexus Manchester Clinical Research Centre
Manchester
Queen's Medical Centre, Nottingham University Hospitals
Nottingham
Synexus North Teesside Clinical Research Centre
Stockton-on-tees
Time Frame
Start Date: 2019-11-19
Completion Date: 2024-01-10
Participants
Target number of participants: 190
Treatments
Experimental: 5 mg Tirzepatide
5 milligrams (mg) tirzepatide administered subcutaneously (SC) once a week.
Experimental: 10 mg Tirzepatide
10 mg tirzepatide administered SC once a week.
Experimental: 15 mg Tirzepatide
15 mg tirzepatide administered SC once a week.
Placebo_comparator: Placebo
Placebo administered SC once a week.
Authors
Marcin Ojrzanowski, Charles Landis, Meagan Gray, Kevin Merkes, Eric Lawitz, Meena Bansal, Seth J. Baum, William P. Jennings, Laura M Pearlman, Donna M DeSantis, Robert A Jenders, James S Magee, Gholamreza Bonabi, Gary Reiss, Raj K Vuppalanchi, Stanley Hsia, Gadi Lalazar, Samuel Sigal, AJAY CHAUDHURI, Pablo Mora, Agustin Albillos Martinez, Ira Jacobson, Syed Lateef, Juan P Frias, Robert Godfrey Perry, Christopher Still, Hernan A Salazar, Sherwin D'Souza, Rizwana H. Mohseni, Omar Massoud, Abdullah Mubarak, Andrew Talal, Brian Borg, Mark T Leibowitz, Mark Borchelt, Randall J Severance, Kathryn Jean Lucas, Richard M Glover, Kenneth Cusi, Hesham Elgouhari, Thomas C. Klein, Jewel Johnny White, Mark McKenzie, Tira Chaicha-Brom, Julio Rosenstock, Jeffrey Bruce Rosen, Muhammad Yasin Sheikh, Henry Levine, Susan R Brian, Zeid K. Kayali, Mohammad S Siddiqui, Ralph DeFronzo, HOWARD SCHWARTZ, Michele Reynolds, John Keith Scott, Anuj Bhargava, Marie Lequoy, Jeremy Cobbold, Victor De Ledinghen, Vlad Ratziu, Jude Oben, Charlotte De Vloo, Pinelopi Manousou, Christophe Bureau, William Alazawi, Véronique LOUSTAUD-RATTI, Jerome Boursier, Cyrielle Caussy, Janisha Patel, Kolapo Idowu, Mary Rinella, Sherif Naguib, Amreen Dinani, Ernesto Fuentes, Amon Asgharpour, Takeshi Yokoo, Assy Nimer, Shigetoshi Fujiyama, Yoav Lurie, Masashi Yoneda, Daniel Forton, Ella Veitsman, Yuji Ogawa, Stephen Ryder, Kazuo Notsumata, Ziv Ben-Ari, Jorge Rojas Serrano, Nick Stern, Hiroshi Tobita, Eli Zuckerman, Rifaat Safadi, Hideki Hayashi, Nimer Assy, Emanuela Orsi, Yoshio Sumida, Elisabetta Bugianesi, Christophe De Block, Masaaki Takamura, Masato Yoneda, Yuichiro Eguchi, Kento Imajo, Ken Furuya, Toshihide Shima, Salvatore Petta, Yoshiyuki Ueno, Kosh Agarwal, Ann Mertens, Gaetano Serviddio, Luca Miele, Anja Geerts, Frida Leonetti, Matthew Armstrong, Saiyu Tanaka, Yasuhiro Asahina, Hendrik Reynaert, Jose Luis Calleja, Judith L. White
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov