MedTrace Logo

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

NCT04505436 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 215

Last updated 2025-11-19

No results posted yet for this 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

Conditions

  • NASH - Nonalcoholic Steatohepatitis

Interventions

DRUG

HM15211

A sterile solution of HM15211 (efocipegtrutide) contained in pre-filled syringes

DRUG

Placebo of HM15211

A sterile, matching solution in pre-filled syringes

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-31
Primary Completion
2026-06-27
Completion
2026-07-27
FDA Drug
Yes

Countries

  • United States
  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04505436 on ClinicalTrials.gov