ACTIVE_NOT_RECRUITING

Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects

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Conditions

NASH - Nonalcoholic Steatohepatitis

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2020-07-31
Study Completion:2026-07-27
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT04505436

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * United States Sites: Adults ≥ 18 to ≤ 70 years.
  2. * Korean Sites: Adults ≥ 19 to ≤ 70 years.
  3. * 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.
  4. * Subjects have a diagnosis of non-cirrhotic NASH with liver fibrosis (Fibrosis stage F1-F3) confirmed by liver biopsy within 6 months of Day -7.
  5. * MRI-PDFF performed at screening with ≥ 8% steatosis.
  1. * Subjects with a history of active or chronic liver disease, including alcoholic liver disease, viral hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, Wilson's disease, hemochromatosis, alpha-1 antitrypsin deficiency, human immunodeficiency virus (HIV).
  2. * Any history of clinically significant chronic liver disease including esophageal varices, ascites, hepatic encephalopathy, splenomegaly, or any hospitalization for treatment of chronic liver disease; or Model for End Stage Liver Disease \>12.
  3. * Recent (within 3 months of baseline biopsy) use of therapies associated with development of NAFLD (e.g., systemic corticosteroids, methotrexate, tamoxifen, aromatase inhibitors, amiodarone, or long-term use of tetracyclines).
  4. * Type 1 diabetes subjects, or T2DM subjects on GLP-1 receptor agonist therapy, or other therapies not allowed for this study

Contacts and Locations

Study Locations (Sites)

North Alabama GI Research Center
Huntsville, Alabama, 35801
United States
Synexus US - Chandler
Chandler, Arizona, 85224
United States
Precision Research Institute, LLC. (PRI)
Chula Vista, California, 91910
United States
Fresno Clinical Research Center
Fresno, California, 93720
United States
NAFLD Research Center - Altman Clinical and Translational Research Institute
La Jolla, California, 92037
United States
UC Davis Health System - Midtown Ambulatory Care Center
Sacramento, California, 95816
United States
University of Florida College of Medicine
Gainesville, Florida, 32610
United States
San Marcus Research Clinic
Miami Lakes, Florida, 330145602
United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, 33016
United States
Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM)
Miami, Florida, 33136
United States
Ocala GI Research
Ocala, Florida, 34471
United States
Synexus Clinical Research US, Inc. - Orlando
Orlando, Florida, 32806
United States
Synexus Clinical Research US, Inc. - The Villages
The Villages, Florida, 32162
United States
Synexus Clinical Research US, Inc
Chicago, Illinois, 60602
United States
Gastroenterology Health Partners, PLLC - Southern Indiana
New Albany, Indiana, 47150
United States
Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza
Topeka, Kansas, 66606-1707
United States
Tandem Clinical Research, LLC
Marrero, Louisiana, 70072
United States
University of Maryland Medical Center
Baltimore, Maryland, 21201
United States
Mercy Medical Center - The Institute for Digestive Health and Liver Disease
Baltimore, Maryland, 21202-2102
United States
Brigham and Women's hospital
Boston, Massachusetts, 02115
United States
Henry Ford Hospital
Detroit, Michigan, 48202-2608
United States
West Michigan Clinical Research Center
Wyoming, Michigan, 49519
United States
Mayo Clinic Rochester
Rochester, Minnesota, 55905
United States
Nevada Family Care & Wellness Center
Henderson, Nevada, 89052
United States
Tandem Clinical Research, LLC
New York, New York, 10033
United States
UNC Health Care System
Chapel Hill, North Carolina, 27514
United States
Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
Charlotte, North Carolina, 28204
United States
Duke University Medical Center
Durham, North Carolina, 27710-4000
United States
Lucas Research
Morehead City, North Carolina, 28557
United States
Consultants for Clinical Research
Liberty Township, Ohio, 45044
United States
University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases
Pittsburgh, Pennsylvania, 15213
United States
ClinSearch
Chattanooga, Tennessee, 37421
United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012
United States
Texas Liver Institute (TLI) - Texas Metabolic Center
Austin, Texas, 78757-7571
United States
The Liver Institute at Methodist Dallas
Dallas, Texas, 75203
United States
Dallas Diabetes and Endocrine Center
Dallas, Texas, 75230
United States
Liver Center of Texas, PLLC
Dallas, Texas, 75234
United States
Synexus Clinical Research US, Inc
Dallas, Texas, 75234
United States
Digestive Health Associates of Texas, P.A. (DHAT)
Garland, Texas, 75044
United States
Baylor College of Medicine - Advanced Liver Therapies
Houston, Texas, 77030
United States
Centex Studies, Inc.
Houston, Texas, 77058
United States
Pioneer Research Solutions Inc
Houston, Texas, 77099-4307
United States
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215
United States
University of Utah Health Care - UUHC - Kidney & Liver Clinic
Salt Lake City, Utah, 84132
United States
Bon Secours Liver Institute of Virginia - Newport News
Newport News, Virginia, 23602
United States
Virginia Commonwealth University (VCU) Medical Center
Richmond, Virginia, 23298
United States
University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic
Seattle, Washington, 98104
United States
Liver Institute Northwest
Seattle, Washington, 98105
United States

Collaborators and Investigators

Sponsor: Hanmi Pharmaceutical Company Limited

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-07-31
Study Completion Date2026-07-27

Study Record Updates

Study Start Date2020-07-31
Study Completion Date2026-07-27

Terms related to this study

Additional Relevant MeSH Terms

  • NASH - Nonalcoholic Steatohepatitis