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Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)

NCT06569524 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2024-08-26

No results posted yet for this study

Summary

A randomized, double-blind, placebo-controlled Phase II study，to evaluate the efficacy and safety of TQA2225/AP025 in Patients With Non-Alcoholic Steatohepatitis (NASH)

Conditions

  • Non-alcoholic Steatohepatitis

Interventions

DRUG

TQA2225/AP025 or TQA2225/AP025 Placebo 25mg

To evaluate the efficacy and safety of TQA2225/AP025 (25mg) in patients with Non-Alcoholic Steatohepatitis (NASH)

DRUG

TQA2225/AP025 or TQA2225/AP025 Placebo 50mg

To evaluate the efficacy and safety of TQA2225/AP025 (50mg) in patients with Non-Alcoholic Steatohepatitis (NASH)

Sponsors & Collaborators

  • Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-09-14
Primary Completion
2026-12-31
Completion
2027-12-31

Countries

  • China

Study Locations

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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 NCT06569524 on ClinicalTrials.gov