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

October 23, 2023 updated by: Hanmi Pharmaceutical Company Limited

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate Efficacy, Safety and Tolerability of HM15211 Treatment for 12 Months in Subjects With Biopsy Confirmed NASH

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 08308
        • Recruiting
        • Korea University Guro Hospital
        • Principal Investigator:
          • Ji Hoon Kim
        • Contact:
          • Ji Hoon Kim
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital
        • Contact:
          • JunYong Park
        • Principal Investigator:
          • JunYong Park
      • Seoul, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University College of Medicine - Liver Research Institute
        • Principal Investigator:
          • Yoon Jun Kim, Ph.D
      • Seoul, Korea, Republic of, 07061
        • Recruiting
        • SMG-SNU Boramae Medical Center
        • Principal Investigator:
          • Won Kim
        • Contact:
          • Won Kim
      • Seoul, Korea, Republic of, 10444
        • Recruiting
        • Natinal health insurance service Ilsan hospital
        • Contact:
          • Chun Kyon Lee
        • Principal Investigator:
          • Chun Kyon Lee
      • Seoul, Korea, Republic of, 04763
        • Not yet recruiting
        • Hanyang University Seoul Hospital
        • Contact:
          • Daewon Jun
        • Principal Investigator:
          • Daewon Jun
      • Seoul, Korea, Republic of, 03312
        • Not yet recruiting
        • Eunpyeong St. Mary Hospital
        • Contact:
          • Si Hyun Bae
        • Principal Investigator:
          • Si Hyun Bae
    • Gyeonggi-do
      • Ansan, Gyeonggi-do, Korea, Republic of, 15355
        • Not yet recruiting
        • Korea University Ansan Hospital
        • Contact:
          • Young Kul Jung
        • Principal Investigator:
          • Young Kul Jung
      • Bucheon, Gyeonggi-do, Korea, Republic of, 14584
        • Not yet recruiting
        • Soonchunhyang University Bucheon Hospital
        • Contact:
          • Sang Gyune Kim
        • Principal Investigator:
          • Sang Gyune Kim
      • Suwon, Gyeonggi-do, Korea, Republic of, 16499
        • Not yet recruiting
        • Ajou University Hospital
        • Contact:
          • Soon Sun Kim
        • Principal Investigator:
          • Soon Sun Kim
  • United States
    • Alabama
      • Madison, Alabama, United States, 35758-2632
        • Recruiting
        • North Alabama GI Research Center
        • Contact:
          • Michael Brown
        • Principal Investigator:
          • Michael Brown
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego School of Medicine - Altman Clinical and Translational Research Institute
        • Principal Investigator:
          • Rohit Loomba
        • Contact:
          • Rohit Loomba
      • Los Angeles, California, United States, 70072-3155
        • Recruiting
        • Tandem Clinical Research, LLC
        • Contact:
          • Gary Reiss
        • Principal Investigator:
          • Gary Reiss
      • Sacramento, California, United States, 95816
        • Recruiting
        • UC Davis Health System - Midtown Ambulatory Care Center
        • Contact:
          • Souvik Sarkar
        • Principal Investigator:
          • Souvik Sarkar
      • San Diego, California, United States, 92114-3629
        • Recruiting
        • Precision Research Institute, LLC. (PRI)
        • Contact:
          • Ivan Cubas
        • Principal Investigator:
          • Ivan Cubas
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida College of Medicine
        • Contact:
          • Virginia Clark
        • Principal Investigator:
          • Virginia Clark
      • Miami, Florida, United States, 33136
        • Recruiting
        • Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM)
        • Contact:
          • Eugene Schiff
        • Principal Investigator:
          • Eugene Schiff
      • Miami Lakes, Florida, United States, 33016
        • Recruiting
        • Floridian Clinical Research, LLC
        • Contact:
          • William Sanchez
        • Principal Investigator:
          • William Sanchez
      • Miami Lakes, Florida, United States, 330145602
        • Recruiting
        • San Marcus Research Clinic
        • Principal Investigator:
          • MARIA CUESTA TORRES
        • Contact:
          • Maria Cuesta torres
      • Ocala, Florida, United States, 34471
        • Recruiting
        • Ocala GI Research
        • Contact:
          • Robert Barish
        • Principal Investigator:
          • Robert Barish
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Bioclinica Research - Orlando/Synexus Clinical Research US, Inc.
        • Contact:
          • Judith White
        • Principal Investigator:
          • Judith White
      • The Villages, Florida, United States, 32162
        • Terminated
        • Synexus Clinical Research US, Inc. - The Villages
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Terminated
        • Synexus Clinical Research US, Inc
    • Kansas
      • Topeka, Kansas, United States, 66606-1707
        • Recruiting
        • Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza
        • Contact:
          • Shekhar Challa
        • Principal Investigator:
          • Shekhar Challa
    • Louisiana
      • Marrero, Louisiana, United States, 70072
        • Recruiting
        • Tandem Clinical Research, LLC
        • Contact:
          • Lincoln Hernandez
        • Principal Investigator:
          • Lincoln Hernandez
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Medical Center
        • Contact:
          • Kirti Shetty
        • Principal Investigator:
          • Kirti Shetty
      • Baltimore, Maryland, United States, 21202-2102
        • Recruiting
        • Mercy Medical Center - The Institute for Digestive Health and Liver Disease
        • Contact:
          • Anurag Maheshwari
        • Principal Investigator:
          • Anurag Maheshwari
    • Michigan
      • Detroit, Michigan, United States, 48202-2608
        • Recruiting
        • Henry Ford Hospital
        • Contact:
          • Humberto Gonzalez
        • Principal Investigator:
          • Humberto Gonzalez
      • Wyoming, Michigan, United States, 49519
        • Recruiting
        • Gastroenterology Associates of Western Michigan
        • Principal Investigator:
          • Allan Coates
        • Contact:
          • Allan Coates
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic Rochester
        • Contact:
          • Manal F Abdelmalek
        • Principal Investigator:
          • Manal F Abdelmalek
    • Nevada
      • Henderson, Nevada, United States, 98052
        • Recruiting
        • Synexus Clinical Research US, Inc - Henderson
        • Contact:
          • Cornell Calinescu
        • Principal Investigator:
          • Cornell Calinescu
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27514
        • Recruiting
        • UNC Health Care System
        • Contact:
          • Alfred Barritt
        • Principal Investigator:
          • Alfred Barritt
      • Durham, North Carolina, United States, 27710-4000
        • Recruiting
        • Duke University Medical Center
        • Contact:
          • Ayako Suzuki
        • Principal Investigator:
          • Ayako Suzuki
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
        • Contact:
          • Robert Reindollar
        • Principal Investigator:
          • Robert Reindollar
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Lucas Research
        • Contact:
          • Kathryn Lucas
        • Principal Investigator:
          • Kathryn Lucas
    • Ohio
      • Cincinnati, Ohio, United States, 45249-2291
        • Recruiting
        • Ohio Gastroenterology & Liver Institute (GI) (Greater Cincinnati Gastroenterology Associates Inc) - Montgomery Office
        • Contact:
          • Ravi Ravinuthala
        • Principal Investigator:
          • Ravi Ravinuthala
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • Recruiting
        • University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases
        • Contact:
          • Mordechai Rabinovitz
        • Principal Investigator:
          • Mordechai Rabinovitz
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421-1688
        • Recruiting
        • Wake Research Associates, LLC (WRA)
        • Contact:
          • Mark Mckenzie
        • Principal Investigator:
          • Mark Mckenzie
    • Texas
      • Arlington, Texas, United States, 76012
        • Recruiting
        • Texas Digestive Disease Consultants, P.A. (TDDC)
        • Contact:
          • Reem Ghalib
        • Principal Investigator:
          • Reem Ghalib
      • Dallas, Texas, United States, 75203
        • Recruiting
        • The Liver Institute at Methodist Dallas
        • Principal Investigator:
          • Parvez Mantry
        • Contact:
          • Parvez Mantry
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Dallas Diabetes and Endocrine Center
        • Contact:
          • Julio Rosenstock
        • Principal Investigator:
          • Julio Rosenstock
      • Dallas, Texas, United States, 75234
        • Recruiting
        • Liver Center of Texas, PLLC
        • Principal Investigator:
          • Abdullah Mubarak
        • Contact:
          • Abdullah Mubarak
      • Dallas, Texas, United States, 75234
        • Terminated
        • Synexus Clinical Research US, Inc
      • Houston, Texas, United States, 77030
        • Recruiting
        • St. Luke's Episcopal Hospital - Advanced Liver Therapies Research
        • Contact:
          • John Vierling
        • Principal Investigator:
          • John Vierling
      • Houston, Texas, United States, 77099-4307
        • Recruiting
        • Pioneer Research Solutions Inc
        • Contact:
          • Francisco Velazquez
        • Principal Investigator:
          • Francisco Velazquez
      • Rockwall, Texas, United States, 75032-7045
        • Recruiting
        • Digestive Health Associates of Texas, P.A. (DHAT)
        • Contact:
          • Harry Sarles
        • Principal Investigator:
          • Harry Sarles
      • San Antonio, Texas, United States, 78215-1610
        • Recruiting
        • Texas Liver Institute (TLI) - Texas Metabolic Center
        • Contact:
          • Eric Lawitz
        • Principal Investigator:
          • Eric Lawitz
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Health Care - UUHC - Kidney & Liver Clinic
        • Contact:
          • Juan Gallegos-Orozco
        • Principal Investigator:
          • Juan Gallegos-Orozco
    • Virginia
      • Newport News, Virginia, United States, 23602
        • Recruiting
        • Bon Secours Liver Institute of Virginia - Newport News
        • Contact:
          • Mitchell Shiffman
        • Principal Investigator:
          • Mitchell Shiffman
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University (VCU) Medical Center
        • Contact:
          • Velimir Luketic
        • Principal Investigator:
          • Velimir Luketic
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • Liver Institute Northwest
        • Contact:
          • Kris Kowdley
        • Principal Investigator:
          • Kris Kowdley
      • Seattle, Washington, United States, 98104
        • Terminated
        • University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic

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.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • 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.
  • 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).
  • Type 1 diabetes subjects, or T2DM subjects on insulin and/or GLP-1 receptor agonist therapy, or other therapies not allowed for this study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo of HM15211
A sterile, matching solution in pre-filled syringes
Experimental: HM15211
Drug: HM15211
A sterile solution of HM15211 contained in pre-filled syringes

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pharmacodynamic (PD) effect of HM15211
Time Frame: 12 months
Proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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 Major Dates

Study Start (Actual)

July 31, 2020

Primary Completion (Estimated)

May 11, 2025

Study Completion (Estimated)

November 10, 2025

Study Registration Dates

First Submitted

August 7, 2020

First Submitted That Met QC Criteria

August 7, 2020

First Posted (Actual)

August 10, 2020

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HM-TRIA-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on NASH - Nonalcoholic Steatohepatitis

Clinical Trials on HM15211

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Italy

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe