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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

About this trial

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)

Eligibility criteria

Qualifiers

Must be willing to participate in the study and provide written informed consent.

Male or female aged 18 ≤ age < 75 at the time of signing the informed consent.

Must have had prior liver biopsy within 180 days of randomization with fibrosis stage 1 to 3 and a NAS of ≥4 with at least a score of 1 in each of the lobular inflammation and ballooning degeneration.

Confirmation of ≥10% liver fat content on Magnetic resonance imaging-derived proton density fat fraction (MRI-PDFF).

Disqualifiers

Documented causes of chronic liver disease other than NASH

Type 1 diabetes or uncontrolled Type 2 diabetes defined as:Hemoglobin A1c ≥9% at screening,Fasting blood glucose≥13.9mmol/l

Uncontrolled hypertension at Screening (values ≥160/100 mm Hg)

History or presence of cirrhosis

Trial design

Treatments tested in this trial

  • TQA2225/AP025 or TQA2225/AP025 Placebo 25mg
  • TQA2225/AP025 or TQA2225/AP025 Placebo 50mg

Treatment groups

120 Participants
are divided into 2 treatment groups