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

Primary Purpose

NASH - Nonalcoholic Steatohepatitis

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
HM15211
Placebo of HM15211
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for NASH - Nonalcoholic Steatohepatitis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adults ≥ 18 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

Sites / Locations

  • North Alabama GI Research CenterRecruiting
  • UC San Diego School of Medicine - Altman Clinical and Translational Research InstituteRecruiting
  • Tandem Clinical Research, LLCRecruiting
  • UC Davis Health System - Midtown Ambulatory Care CenterRecruiting
  • Precision Research Institute, LLC. (PRI)Recruiting
  • University of Florida College of MedicineRecruiting
  • San Marcus Research ClinicRecruiting
  • Floridian Clinical Research, LLCRecruiting
  • Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM)Recruiting
  • Ocala GI ResearchRecruiting
  • Bioclinica Research - Orlando/Synexus Clinical Research US, Inc.Recruiting
  • Synexus Clinical Research US, Inc. - The Villages
  • Synexus Clinical Research US, Inc
  • Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical PlazaRecruiting
  • Tandem Clinical Research, LLCRecruiting
  • University of Maryland Medical CenterRecruiting
  • Mercy Medical Center - The Institute for Digestive Health and Liver DiseaseRecruiting
  • Henry Ford HospitalRecruiting
  • Gastroenterology Associates of Western MichiganRecruiting
  • Mayo Clinic RochesterRecruiting
  • Synexus Clinical Research US, Inc - HendersonRecruiting
  • UNC Health Care SystemRecruiting
  • Duke University Medical CenterRecruiting
  • Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium HealthRecruiting
  • Lucas ResearchRecruiting
  • Ohio Gastroenterology & Liver Institute (GI) (Greater Cincinnati Gastroenterology Associates Inc) - Montgomery OfficeRecruiting
  • University of Pittsburgh Medical Center (UPMC) - The Center for Liver DiseasesRecruiting
  • Wake Research Associates, LLC (WRA)Recruiting
  • Texas Digestive Disease Consultants, P.A. (TDDC)Recruiting
  • The Liver Institute at Methodist DallasRecruiting
  • Dallas Diabetes and Endocrine CenterRecruiting
  • Liver Center of Texas, PLLCRecruiting
  • Synexus Clinical Research US, Inc
  • St. Luke's Episcopal Hospital - Advanced Liver Therapies ResearchRecruiting
  • Pioneer Research Solutions IncRecruiting
  • Digestive Health Associates of Texas, P.A. (DHAT)Recruiting
  • Texas Liver Institute (TLI) - Texas Metabolic CenterRecruiting
  • University of Utah Health Care - UUHC - Kidney & Liver ClinicRecruiting
  • Bon Secours Liver Institute of Virginia - Newport NewsRecruiting
  • Virginia Commonwealth University (VCU) Medical CenterRecruiting
  • University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic
  • Liver Institute NorthwestRecruiting
  • Korea University Ansan Hospital
  • Soonchunhyang university bucheon hospital
  • Ajou University Hospital
  • Seoul National University College of Medicine - Liver Research InstituteRecruiting
  • Eunpyeong St. Mary Hospital
  • Severance HospitalRecruiting
  • Hanyang University Seoul Hospital
  • SMG-SNU Boramae Medical CenterRecruiting
  • Korea University Guro HospitalRecruiting
  • Natinal health insurance service Ilsan hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

HM15211

Placebo

Arm Description

Outcomes

Primary Outcome Measures

pharmacodynamic (PD) effect of HM15211
Proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis

Secondary Outcome Measures

Full Information

First Posted
August 7, 2020
Last Updated
October 23, 2023
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT04505436
Brief Title
Study to Evaluate Efficacy, Safety and Tolerability of HM15211 in Subjects
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 31, 2020 (Actual)
Primary Completion Date
May 11, 2025 (Anticipated)
Study Completion Date
November 10, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

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

5. Study Description

Brief 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

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HM15211
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
HM15211
Intervention Description
A sterile solution of HM15211 contained in pre-filled syringes
Intervention Type
Drug
Intervention Name(s)
Placebo of HM15211
Intervention Description
A sterile, matching solution in pre-filled syringes
Primary Outcome Measure Information:
Title
pharmacodynamic (PD) effect of HM15211
Description
Proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jiyeon Kang
Phone
+82 2 410 0377
Email
jiyeon.kang@hanmi.co.kr
Facility Information:
Facility Name
North Alabama GI Research Center
City
Madison
State/Province
Alabama
ZIP/Postal Code
35758-2632
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Brown
First Name & Middle Initial & Last Name & Degree
Michael Brown
Facility Name
UC San Diego School of Medicine - Altman Clinical and Translational Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rohit Loomba
First Name & Middle Initial & Last Name & Degree
Rohit Loomba
Facility Name
Tandem Clinical Research, LLC
City
Los Angeles
State/Province
California
ZIP/Postal Code
70072-3155
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gary Reiss
First Name & Middle Initial & Last Name & Degree
Gary Reiss
Facility Name
UC Davis Health System - Midtown Ambulatory Care Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Souvik Sarkar
First Name & Middle Initial & Last Name & Degree
Souvik Sarkar
Facility Name
Precision Research Institute, LLC. (PRI)
City
San Diego
State/Province
California
ZIP/Postal Code
92114-3629
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Cubas
First Name & Middle Initial & Last Name & Degree
Ivan Cubas
Facility Name
University of Florida College of Medicine
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Virginia Clark
First Name & Middle Initial & Last Name & Degree
Virginia Clark
Facility Name
San Marcus Research Clinic
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
330145602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Cuesta torres
First Name & Middle Initial & Last Name & Degree
Maria Cuesta torres
Facility Name
Floridian Clinical Research, LLC
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Sanchez
First Name & Middle Initial & Last Name & Degree
William Sanchez
Facility Name
Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM)
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eugene Schiff
First Name & Middle Initial & Last Name & Degree
Eugene Schiff
Facility Name
Ocala GI Research
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Barish
First Name & Middle Initial & Last Name & Degree
Robert Barish
Facility Name
Bioclinica Research - Orlando/Synexus Clinical Research US, Inc.
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Judith White
First Name & Middle Initial & Last Name & Degree
Judith White
Facility Name
Synexus Clinical Research US, Inc. - The Villages
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Individual Site Status
Terminated
Facility Name
Synexus Clinical Research US, Inc
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60602
Country
United States
Individual Site Status
Terminated
Facility Name
Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606-1707
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shekhar Challa
First Name & Middle Initial & Last Name & Degree
Shekhar Challa
Facility Name
Tandem Clinical Research, LLC
City
Marrero
State/Province
Louisiana
ZIP/Postal Code
70072
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lincoln Hernandez
First Name & Middle Initial & Last Name & Degree
Lincoln Hernandez
Facility Name
University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirti Shetty
First Name & Middle Initial & Last Name & Degree
Kirti Shetty
Facility Name
Mercy Medical Center - The Institute for Digestive Health and Liver Disease
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21202-2102
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anurag Maheshwari
First Name & Middle Initial & Last Name & Degree
Anurag Maheshwari
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202-2608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Humberto Gonzalez
First Name & Middle Initial & Last Name & Degree
Humberto Gonzalez
Facility Name
Gastroenterology Associates of Western Michigan
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allan Coates
First Name & Middle Initial & Last Name & Degree
Allan Coates
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Manal F Abdelmalek
First Name & Middle Initial & Last Name & Degree
Manal F Abdelmalek
Facility Name
Synexus Clinical Research US, Inc - Henderson
City
Henderson
State/Province
Nevada
ZIP/Postal Code
98052
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cornell Calinescu
First Name & Middle Initial & Last Name & Degree
Cornell Calinescu
Facility Name
UNC Health Care System
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27514
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfred Barritt
First Name & Middle Initial & Last Name & Degree
Alfred Barritt
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710-4000
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayako Suzuki
First Name & Middle Initial & Last Name & Degree
Ayako Suzuki
Facility Name
Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Reindollar
First Name & Middle Initial & Last Name & Degree
Robert Reindollar
Facility Name
Lucas Research
City
Morehead City
State/Province
North Carolina
ZIP/Postal Code
28557
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kathryn Lucas
First Name & Middle Initial & Last Name & Degree
Kathryn Lucas
Facility Name
Ohio Gastroenterology & Liver Institute (GI) (Greater Cincinnati Gastroenterology Associates Inc) - Montgomery Office
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45249-2291
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ravi Ravinuthala
First Name & Middle Initial & Last Name & Degree
Ravi Ravinuthala
Facility Name
University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mordechai Rabinovitz
First Name & Middle Initial & Last Name & Degree
Mordechai Rabinovitz
Facility Name
Wake Research Associates, LLC (WRA)
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421-1688
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Mckenzie
First Name & Middle Initial & Last Name & Degree
Mark Mckenzie
Facility Name
Texas Digestive Disease Consultants, P.A. (TDDC)
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Reem Ghalib
First Name & Middle Initial & Last Name & Degree
Reem Ghalib
Facility Name
The Liver Institute at Methodist Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Parvez Mantry
First Name & Middle Initial & Last Name & Degree
Parvez Mantry
Facility Name
Dallas Diabetes and Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julio Rosenstock
First Name & Middle Initial & Last Name & Degree
Julio Rosenstock
Facility Name
Liver Center of Texas, PLLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Abdullah Mubarak
First Name & Middle Initial & Last Name & Degree
Abdullah Mubarak
Facility Name
Synexus Clinical Research US, Inc
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Individual Site Status
Terminated
Facility Name
St. Luke's Episcopal Hospital - Advanced Liver Therapies Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
John Vierling
First Name & Middle Initial & Last Name & Degree
John Vierling
Facility Name
Pioneer Research Solutions Inc
City
Houston
State/Province
Texas
ZIP/Postal Code
77099-4307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Velazquez
First Name & Middle Initial & Last Name & Degree
Francisco Velazquez
Facility Name
Digestive Health Associates of Texas, P.A. (DHAT)
City
Rockwall
State/Province
Texas
ZIP/Postal Code
75032-7045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Harry Sarles
First Name & Middle Initial & Last Name & Degree
Harry Sarles
Facility Name
Texas Liver Institute (TLI) - Texas Metabolic Center
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215-1610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Lawitz
First Name & Middle Initial & Last Name & Degree
Eric Lawitz
Facility Name
University of Utah Health Care - UUHC - Kidney & Liver Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Juan Gallegos-Orozco
First Name & Middle Initial & Last Name & Degree
Juan Gallegos-Orozco
Facility Name
Bon Secours Liver Institute of Virginia - Newport News
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23602
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mitchell Shiffman
First Name & Middle Initial & Last Name & Degree
Mitchell Shiffman
Facility Name
Virginia Commonwealth University (VCU) Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Velimir Luketic
First Name & Middle Initial & Last Name & Degree
Velimir Luketic
Facility Name
University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Terminated
Facility Name
Liver Institute Northwest
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kris Kowdley
First Name & Middle Initial & Last Name & Degree
Kris Kowdley
Facility Name
Korea University Ansan Hospital
City
Ansan
State/Province
Gyeonggi-do
ZIP/Postal Code
15355
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Kul Jung
First Name & Middle Initial & Last Name & Degree
Young Kul Jung
Facility Name
Soonchunhyang university bucheon hospital
City
Bucheon
State/Province
Gyeonggi-do
ZIP/Postal Code
14584
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Gyune Kim
First Name & Middle Initial & Last Name & Degree
Sang Gyune Kim
Facility Name
Ajou University Hospital
City
Suwon
State/Province
Gyeonggi-do
ZIP/Postal Code
16499
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soon Sun Kim
First Name & Middle Initial & Last Name & Degree
Soon Sun Kim
Facility Name
Seoul National University College of Medicine - Liver Research Institute
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yoon Jun Kim, Ph.D
Facility Name
Eunpyeong St. Mary Hospital
City
Seoul
ZIP/Postal Code
03312
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Si Hyun Bae
First Name & Middle Initial & Last Name & Degree
Si Hyun Bae
Facility Name
Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JunYong Park
First Name & Middle Initial & Last Name & Degree
JunYong Park
Facility Name
Hanyang University Seoul Hospital
City
Seoul
ZIP/Postal Code
04763
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daewon Jun
First Name & Middle Initial & Last Name & Degree
Daewon Jun
Facility Name
SMG-SNU Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Won Kim
First Name & Middle Initial & Last Name & Degree
Won Kim
Facility Name
Korea University Guro Hospital
City
Seoul
ZIP/Postal Code
08308
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ji Hoon Kim
First Name & Middle Initial & Last Name & Degree
Ji Hoon Kim
Facility Name
Natinal health insurance service Ilsan hospital
City
Seoul
ZIP/Postal Code
10444
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chun Kyon Lee
First Name & Middle Initial & Last Name & Degree
Chun Kyon Lee

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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