DRUG
HM15211
A sterile solution of HM15211 (efocipegtrutide) contained in pre-filled syringes
Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects
Status
Active, not recruiting
Phase
Phase 2
Enrollment
215
Locations
60
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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
Interventions
Treatment arms and agents.
DRUG
Placebo of HM15211
A sterile, matching solution in pre-filled syringes
Timeline
From registration to results.
First posted
Aug 10, 2020
Study start
Jul 31, 2020
Primary completion
Jun 27, 2026
Study completion
Jul 27, 2026
Results posted
Not reported
Registry updated
Jun 30, 2026
Outcomes
What the study measures.
Primary outcomes
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
Secondary outcomes
Not reported in the indexed record.
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 70 Years
- Sex
- ALL
- Healthy volunteers
- No
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 non-cirrhotic 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 GLP-1 receptor agonist therapy, or other therapies not allowed for this study
Study locations
60 registered sites.
South Korea · United States. Showing up to 24 locations stored in the fast local snapshot.
North Alabama GI Research Center
Huntsville, Alabama, United States
Synexus US - Chandler
Chandler, Arizona, United States
Precision Research Institute, LLC. (PRI)
Chula Vista, California, United States
Fresno Clinical Research Center
Fresno, California, United States
NAFLD Research Center - Altman Clinical and Translational Research Institute
La Jolla, California, United States
UC Davis Health System - Midtown Ambulatory Care Center
Sacramento, California, United States
University of Florida College of Medicine
Gainesville, Florida, United States
Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM)
Miami, Florida, United States
San Marcus Research Clinic
Miami Lakes, Florida, United States
Floridian Clinical Research, LLC
Miami Lakes, Florida, United States
Ocala GI Research
Ocala, Florida, United States
Synexus Clinical Research US, Inc. - Orlando
Orlando, Florida, United States
Synexus Clinical Research US, Inc. - The Villages
The Villages, Florida, United States
Synexus Clinical Research US, Inc
Chicago, Illinois, United States
Gastroenterology Health Partners, PLLC - Southern Indiana
New Albany, Indiana, United States
Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza
Topeka, Kansas, United States
Tandem Clinical Research, LLC
Marrero, Louisiana, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Mercy Medical Center - The Institute for Digestive Health and Liver Disease
Baltimore, Maryland, United States
Brigham and Women's hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
West Michigan Clinical Research Center
Wyoming, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Nevada Family Care & Wellness Center
Henderson, Nevada, United States
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
Related trials
More studies on Efocipegtrutide.
NCT IDStudyPhase / statusEnrollmentUpdated
A First-in-human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of HM15211(Efocipegtrutide)
Hanmi Pharmaceutical Company Limited · Obesity
Phase 1
Completed
41
2025-02
A Study of Multiple Doses of HM15211(Efocipegtrutide) in Obese Subjects With NAFLD
Hanmi Pharmaceutical Company Limited · NAFLD
Phase 1
Completed
66
2025-01
Related PeptideStat pages
Put the record in context.
Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.