A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) Treatment for 12 Months in Subjects With Biopsy Confirmed NASH
Who is this study for? Patients with biopsy confirmed nonalcoholic steatohepatitis
What treatments are being studied? HM15211
Status: Recruiting
Location: See all (60) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
This study is a phase 2 study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects with Biopsy Confirmed NASH
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• United States Sites: Adults ≥ 18 to ≤ 70 years.
• Korean Sites: Adults ≥ 19 to ≤ 70 years.
• BMI ≥ 18 kg/m2, with stable body weight (defined as change \< 5%) by history for 3 months prior to screening or since baseline liver biopsy, whichever is earlier.
• Subjects have a diagnosis of noncirrhotic NASH with liver fibrosis (Fibrosis stage F1-F3) confirmed by liver biopsy within 6 months of Day -7.
• MRI-PDFF performed at screening with ≥ 8% steatosis.
Locations
United States
Alabama
North Alabama GI Research Center
RECRUITING
Huntsville
Arizona
Synexus US - Chandler
TERMINATED
Chandler
California
Precision Research Institute, LLC. (PRI)
TERMINATED
Chula Vista
Fresno Clinical Research Center
RECRUITING
Fresno
NAFLD Research Center - Altman Clinical and Translational Research Institute
RECRUITING
La Jolla
UC Davis Health System - Midtown Ambulatory Care Center
RECRUITING
Sacramento
Florida
University of Florida College of Medicine
RECRUITING
Gainesville
Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM)
RECRUITING
Miami
Floridian Clinical Research, LLC
RECRUITING
Miami Lakes
San Marcus Research Clinic
RECRUITING
Miami Lakes
Ocala GI Research
RECRUITING
Ocala
Synexus Clinical Research US, Inc. - Orlando
RECRUITING
Orlando
Synexus Clinical Research US, Inc. - The Villages
TERMINATED
The Villages
Illinois
Synexus Clinical Research US, Inc
TERMINATED
Chicago
Indiana
Gastroenterology Health Partners, PLLC - Southern Indiana
TERMINATED
New Albany
Kansas
Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza
RECRUITING
Topeka
Louisiana
Tandem Clinical Research, LLC
RECRUITING
Marrero
Massachusetts
Brigham and Women's hospital
NOT_YET_RECRUITING
Boston
Maryland
Mercy Medical Center - The Institute for Digestive Health and Liver Disease
TERMINATED
Baltimore
University of Maryland Medical Center
TERMINATED
Baltimore
Michigan
Henry Ford Hospital
RECRUITING
Detroit
West Michigan Clinical Research Center
RECRUITING
Wyoming
Minnesota
Mayo Clinic Rochester
RECRUITING
Rochester
North Carolina
UNC Health Care System
RECRUITING
Chapel Hill
Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
TERMINATED
Charlotte
Duke University Medical Center
RECRUITING
Durham
Lucas Research
RECRUITING
Morehead City
Nevada
Nevada Family Care & Wellness Center
RECRUITING
Henderson
New York
Tandem Clinical Research, LLC
RECRUITING
New York
Ohio
Consultants for Clinical Research
TERMINATED
Liberty Township
Pennsylvania
University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases
RECRUITING
Pittsburgh
Tennessee
ClinSearch
RECRUITING
Chattanooga
Texas
Texas Clinical Research Institute, LLC
RECRUITING
Arlington
Texas Liver Institute (TLI) - Texas Metabolic Center
RECRUITING
Austin
Dallas Diabetes and Endocrine Center
RECRUITING
Dallas
Liver Center of Texas, PLLC
RECRUITING
Dallas
Synexus Clinical Research US, Inc
TERMINATED
Dallas
The Liver Institute at Methodist Dallas
RECRUITING
Dallas
Digestive Health Associates of Texas, P.A. (DHAT)
RECRUITING
Garland
Baylor College of Medicine - Advanced Liver Therapies
RECRUITING
Houston
Centex Studies, Inc.
TERMINATED
Houston
Pioneer Research Solutions Inc
TERMINATED
Houston
American Research Corporation at the Texas Liver Institute
RECRUITING
San Antonio
Utah
University of Utah Health Care - UUHC - Kidney & Liver Clinic
RECRUITING
Salt Lake City
Virginia
Bon Secours Liver Institute of Virginia - Newport News
RECRUITING
Newport News
Virginia Commonwealth University (VCU) Medical Center
RECRUITING
Richmond
Washington
Liver Institute Northwest
RECRUITING
Seattle
University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic
TERMINATED
Seattle
Other Locations
Republic of Korea
Korea University Ansan Hospital
RECRUITING
Ansan
Soonchunhyang university bucheon hospital
RECRUITING
Bucheon
Natinal health insurance service Ilsan hospital
RECRUITING
Goyang-si
Eunpyeong St. Mary Hospital
RECRUITING
Seoul
EWHA Womans University Mokdong Hospital
RECRUITING
Seoul
Hanyang University Seoul Hospital
RECRUITING
Seoul
Korea University Guro Hospital
RECRUITING
Seoul
Seoul National University College of Medicine - Liver Research Institute
RECRUITING
Seoul
Severance Hospital
RECRUITING
Seoul
SMG-SNU Boramae Medical Center
RECRUITING
Seoul
Ajou University Hospital
RECRUITING
Suwon
The Catholic University of Korea, St. Vincent Hospital
RECRUITING
Suwon
Contact Information
Primary
Daeun Kim
daeun.kim0428@hanmi.co.kr
+82-2-410-9837
Time Frame
Start Date: 2020-07-31
Estimated Completion Date: 2026-11-10
Participants
Target number of participants: 240
Treatments
Experimental: HM15211
Placebo_comparator: Placebo
Authors
Judith White, Charles Landis, Donna DeSantis, Gilbert Jenouri, Ivan Cubas, Joseph Newberg, Souvik Sarkar, Kirti Shetty, John Vierling, Randall Severance, Joe Pouzar, Mark Mckenzie, Julio Rosenstock, Robert Reindollar, Anurag Maheshwari, Huey Nguyen, Michele Reynolds, Manal Abdelmalek, Cornell Calinescu
Related Therapeutic Areas
Sponsors
Leads: Hanmi Pharmaceutical Company Limited