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ACTIVE NOT RECRUITING Phase 2

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

NCT04505436 · View on ClinicalTrials.gov ↗

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

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04505436

The ClinicalTrials.gov registry entry for NCT04505436 describes a study currently listed as active not recruiting. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 215 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hanmi Pharmaceutical Company Limited, which has 98 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04505436 reports 20 study locations spanning 10 distinct geographic areas — top geographies include Florida, California, Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04505436?

The interventions under investigation include: HM15211 (DRUG), Placebo of HM15211 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04505436?

This trial is sponsored by Hanmi Pharmaceutical Company Limited, which has 98 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

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