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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 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 261-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (18% lower). The trial reports 20 study locations across 10 states.

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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

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

FieldValue
Enrollment Target 215 participants
Start Date 2020-07-31
Est. Completion 2026-07-27
Phase Phase 2

What the Registry Record Tells You About NCT04505436

The ClinicalTrials.gov registry entry for NCT04505436 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 261-participant average among 27 other NASH - Nonalcoholic Steatohepatitis trials with a reported enrollment target (18% lower). The listed sponsor is Hanmi Pharmaceutical Company Limited, which has 25 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.