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

Sponsor

Hanmi Pharmaceutical Company Limited (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04505436

Collaborator

(none)

217

Enrollment

Locations

Arms

63.3

Anticipated Duration (Months)

4.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

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

Condition or Disease	Intervention/Treatment	Phase
NASH - Nonalcoholic Steatohepatitis	Drug: HM15211 Drug: Placebo of HM15211	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

217 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jul 31, 2020

Anticipated Primary Completion Date :

May 11, 2025

Anticipated Study Completion Date :

Nov 10, 2025

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: HM15211

Drug: HM15211

A sterile solution of HM15211 contained in pre-filled syringes

Placebo Comparator: Placebo

Drug: Placebo of HM15211

A sterile, matching solution in pre-filled syringes

Outcome Measures

Primary Outcome Measures

pharmacodynamic (PD) effect of HM15211 [12 months]
Proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	North Alabama GI Research Center	Madison	Alabama	United States	35758-2632
2	UC San Diego School of Medicine - Altman Clinical and Translational Research Institute	La Jolla	California	United States	92037
3	Tandem Clinical Research, LLC	Los Angeles	California	United States	70072-3155
4	UC Davis Health System - Midtown Ambulatory Care Center	Sacramento	California	United States	95816
5	Precision Research Institute, LLC. (PRI)	San Diego	California	United States	92114-3629
6	University of Florida College of Medicine	Gainesville	Florida	United States	32610
7	San Marcus Research Clinic	Miami Lakes	Florida	United States	330145602
8	Floridian Clinical Research, LLC	Miami Lakes	Florida	United States	33016
9	Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM)	Miami	Florida	United States	33136
10	Ocala GI Research	Ocala	Florida	United States	34471
11	Bioclinica Research - Orlando/Synexus Clinical Research US, Inc.	Orlando	Florida	United States	32806
12	Synexus Clinical Research US, Inc. - The Villages	The Villages	Florida	United States	32162
13	Synexus Clinical Research US, Inc	Chicago	Illinois	United States	60602
14	Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza	Topeka	Kansas	United States	66606-1707
15	Tandem Clinical Research, LLC	Marrero	Louisiana	United States	70072
16	University of Maryland Medical Center	Baltimore	Maryland	United States	21201
17	Mercy Medical Center - The Institute for Digestive Health and Liver Disease	Baltimore	Maryland	United States	21202-2102
18	Henry Ford Hospital	Detroit	Michigan	United States	48202-2608
19	Gastroenterology Associates of Western Michigan	Wyoming	Michigan	United States	49519
20	Mayo Clinic Rochester	Rochester	Minnesota	United States	55905
21	Synexus Clinical Research US, Inc - Henderson	Henderson	Nevada	United States	98052
22	UNC Health Care System	Chapel Hill	North Carolina	United States	27514
23	Duke University Medical Center	Durham	North Carolina	United States	27710-4000
24	Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health	Huntersville	North Carolina	United States	28078
25	Lucas Research	Morehead City	North Carolina	United States	28557
26	Ohio Gastroenterology & Liver Institute (GI) (Greater Cincinnati Gastroenterology Associates Inc) - Montgomery Office	Cincinnati	Ohio	United States	45249-2291
27	University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases	Pittsburgh	Pennsylvania	United States	15213
28	Wake Research Associates, LLC (WRA)	Chattanooga	Tennessee	United States	37421-1688
29	Texas Digestive Disease Consultants, P.A. (TDDC)	Arlington	Texas	United States	76012
30	The Liver Institute at Methodist Dallas	Dallas	Texas	United States	75203
31	Dallas Diabetes and Endocrine Center	Dallas	Texas	United States	75230
32	Liver Center of Texas, PLLC	Dallas	Texas	United States	75234
33	Synexus Clinical Research US, Inc	Dallas	Texas	United States	75234
34	St. Luke's Episcopal Hospital - Advanced Liver Therapies Research	Houston	Texas	United States	77030
35	Pioneer Research Solutions Inc	Houston	Texas	United States	77099-4307
36	Digestive Health Associates of Texas, P.A. (DHAT)	Rockwall	Texas	United States	75032-7045
37	Texas Liver Institute (TLI) - Texas Metabolic Center	San Antonio	Texas	United States	78215-1610
38	University of Utah Health Care - UUHC - Kidney & Liver Clinic	Salt Lake City	Utah	United States	84132
39	Bon Secours Liver Institute of Virginia - Newport News	Newport News	Virginia	United States	23602
40	Virginia Commonwealth University (VCU) Medical Center	Richmond	Virginia	United States	23298
41	University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic	Seattle	Washington	United States	98104
42	Liver Institute Northwest	Seattle	Washington	United States	98105
43	Seoul National University College of Medicine - Liver Research Institute	Seoul		Korea, Republic of	03080
44	Severance Hospital	Seoul		Korea, Republic of	03722
45	SMG-SNU Boramae Medical Center	Seoul		Korea, Republic of	07061
46	Korea University Guro Hospital	Seoul		Korea, Republic of	08308
47	Natinal health insurance service Ilsan hospital	Seoul		Korea, Republic of	10444

Sponsors and Collaborators

Hanmi Pharmaceutical Company Limited

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hanmi Pharmaceutical Company Limited

ClinicalTrials.gov Identifier:

NCT04505436

Other Study ID Numbers:

HM-TRIA-201

First Posted:

Aug 10, 2020

Last Update Posted:

Aug 24, 2022

Last Verified:

Aug 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Fatty Liver

Non-alcoholic Fatty Liver Disease

Study Results

No Results Posted as of Aug 24, 2022