Clinical trial NCT04505436: Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: NASH - Nonalcoholic Steatohepatitis
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2020-08-10
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: pharmacodynamic (PD) effect of HM15211
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: North Alabama GI Research Center
state: Alabama
city: Chandler
country: United States
facility: Synexus US - Chandler
state: Arizona
city: Chula Vista
country: United States
facility: Precision Research Institute, LLC. (PRI)
state: California
city: Fresno
country: United States
facility: Fresno Clinical Research Center
state: California
city: La Jolla
country: United States
facility: NAFLD Research Center - Altman Clinical and Translational Research Institute
state: California
city: Sacramento
country: United States
facility: UC Davis Health System - Midtown Ambulatory Care Center
state: California
city: Gainesville
country: United States
facility: University of Florida College of Medicine
state: Florida
city: Miami Lakes
country: United States
facility: San Marcus Research Clinic
state: Florida
city: Miami Lakes
country: United States
facility: Floridian Clinical Research, LLC
state: Florida
city: Miami
country: United States
facility: Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM)
state: Florida
city: Ocala
country: United States
facility: Ocala GI Research
state: Florida
city: Orlando
country: United States
facility: Synexus Clinical Research US, Inc. - Orlando
state: Florida
city: The Villages
country: United States
facility: Synexus Clinical Research US, Inc. - The Villages
state: Florida
city: Chicago
country: United States
facility: Synexus Clinical Research US, Inc
state: Illinois
city: New Albany
country: United States
facility: Gastroenterology Health Partners, PLLC - Southern Indiana
state: Indiana
city: Topeka
country: United States
facility: Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza
state: Kansas
city: Marrero
country: United States
facility: Tandem Clinical Research, LLC
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Medical Center
state: Maryland
city: Baltimore
country: United States
facility: Mercy Medical Center - The Institute for Digestive Health and Liver Disease
state: Maryland
city: Boston
country: United States
facility: Brigham and Women's hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Wyoming
country: United States
facility: West Michigan Clinical Research Center
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
city: Henderson
country: United States
facility: Nevada Family Care & Wellness Center
state: Nevada
city: New York
country: United States
facility: Tandem Clinical Research, LLC
state: New York
city: Chapel Hill
country: United States
facility: UNC Health Care System
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Center for Liver Disease, Carolinas HealthCare System/Atrium Health
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Morehead City
country: United States
facility: Lucas Research
state: North Carolina
city: Liberty Township
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center (UPMC) - The Center for Liver Diseases
state: Pennsylvania
city: Chattanooga
country: United States
facility: ClinSearch
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute, LLC
state: Texas
city: Austin
country: United States
facility: Texas Liver Institute (TLI) - Texas Metabolic Center
state: Texas
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas
state: Texas
city: Dallas
country: United States
facility: Dallas Diabetes and Endocrine Center
state: Texas
city: Dallas
country: United States
facility: Liver Center of Texas, PLLC
state: Texas
city: Dallas
country: United States
facility: Synexus Clinical Research US, Inc
state: Texas
city: Garland
country: United States
facility: Digestive Health Associates of Texas, P.A. (DHAT)
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Advanced Liver Therapies
state: Texas
city: Houston
country: United States
facility: Centex Studies, Inc.
state: Texas
city: Houston
country: United States
facility: Pioneer Research Solutions Inc
state: Texas
city: San Antonio
country: United States
facility: American Research Corporation at the Texas Liver Institute
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah Health Care - UUHC - Kidney & Liver Clinic
state: Utah
city: Newport News
country: United States
facility: Bon Secours Liver Institute of Virginia - Newport News
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University (VCU) Medical Center
state: Virginia
city: Seattle
country: United States
facility: University of Washington (UW) - Harborview Medical Center (HMC) - Hepatitis and Liver Clinic
state: Washington
city: Seattle
country: United States
facility: Liver Institute Northwest
state: Washington
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Bucheon
country: Korea, Republic of
facility: Soonchunhyang university bucheon hospital
state: Gyeonggi-do
city: Goyang-si
country: Korea, Republic of
facility: Natinal health insurance service Ilsan hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent Hospital
state: Gyeonggi-do
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Seoul National University College of Medicine - Liver Research Institute
city: Seoul
country: Korea, Republic of
facility: Eunpyeong St. Mary Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: SMG-SNU Boramae Medical Center
city: Seoul
country: Korea, Republic of
facility: EWHA Womans University Mokdong Hospital
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital
Study officials:
References: