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NCT04505436 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects
A Phase 2 study of NASH - Nonalcoholic Steatohepatitis, sponsored by Hanmi Pharmaceutical Company Limited.
- Active
- Registry status
- Phase 2
- Development phase
- 215
- Enrollment target
- 20
- Study locations
NCT04505436: Active Phase 2 study of NASH - Nonalcoholic Steatohepatitis, sponsored by Hanmi Pharmaceutical Company Limited.
NCT04505436 is a Phase 2 study of NASH - Nonalcoholic Steatohepatitis that is active but no longer recruiting, run by Hanmi Pharmaceutical Company Limited. The registered enrollment target is 215 participants, below the 254-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (15% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04505436, a Phase 2 study of NASH - Nonalcoholic Steatohepatitis, is active but no longer recruiting, sponsored by Hanmi Pharmaceutical Company Limited.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 215 participants
- Enrollment target
- 20
- Study locations
Study 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
Primary Outcome
Proportion of subjects who achieve resolution of steatohepatitis on overall histopathological reading and no worsening of liver fibrosis
Conditions Studied
Interventions
- DRUG HM15211
- DRUG Placebo of HM15211
Study Locations (20)
Florida
- University of Florida College of Medicine - Gainesville
- Schiff Center for Liver Diseases - University of Miami Leonard M. Miller School of Medicine(UMMSM) - Miami
- San Marcus Research Clinic - Miami Lakes
- Floridian Clinical Research, LLC - Miami Lakes
- Ocala GI Research - Ocala
- Synexus Clinical Research US, Inc. - Orlando - Orlando
- Synexus Clinical Research US, Inc. - The Villages - The Villages
California
- Precision Research Institute, LLC. (PRI) - Chula Vista
- Fresno Clinical Research Center - Fresno
- NAFLD Research Center - Altman Clinical and Translational Research Institute - La Jolla
- UC Davis Health System - Midtown Ambulatory Care Center - Sacramento
Maryland
- University of Maryland Medical Center - Baltimore
- Mercy Medical Center - The Institute for Digestive Health and Liver Disease - Baltimore
Alabama
- North Alabama GI Research Center - Huntsville
Arizona
- Synexus US - Chandler - Chandler
Illinois
- Synexus Clinical Research US, Inc - Chicago
Indiana
- Gastroenterology Health Partners, PLLC - Southern Indiana - New Albany
Kansas
- Kansas Medical Clinic PA (KMC) - Gastrointestinal Medical Plaza - Topeka
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 215 participants |
| Start Date | 2020-07-31 |
| Est. Completion | 2026-07-27 |
| Phase | Phase 2 |
What the registry record for NCT04505436 still lists
NCT04505436 is an interventional study that assigns participants to a tested intervention. The registered 215 participants enrollment target is mid-sized for trials with a published cap, below the 254-participant average among 28 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (15% lower).
The record links to 1 condition, with NASH - Nonalcoholic Steatohepatitis appearing as the primary indexed condition, and to 2 interventions - of which HM15211 is the first listed.
NCT04505436 names 20 study sites across 10 states, led by Florida, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT04505436 about?
NCT04505436 is a clinical study titled "Study to Evaluate Efficacy, Safety and Tolerability of HM15211(Efocipegtrutide) in Subjects". 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
What is the current status of trial NCT04505436?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 215 participants. The study started on 2020-07-31. Estimated completion is 2026-07-27.
What conditions does trial NCT04505436 study?
This clinical trial studies the following conditions: NASH - Nonalcoholic Steatohepatitis.
What interventions are being tested in trial NCT04505436?
The interventions under investigation include: HM15211 (DRUG), Placebo of HM15211 (DRUG).
Who is sponsoring clinical trial NCT04505436?
This trial is sponsored by Hanmi Pharmaceutical Company Limited, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04505436 being conducted?
This trial has 20 study locations across Alabama, Arizona, California, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for NASH - Nonalcoholic Steatohepatitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04505436's enrollment target sits among peer trials
215 9th of 28 higher than 20 of 28 other NASH - Nonalcoholic Steatohepatitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NASH - Nonalcoholic Steatohepatitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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