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Recruiting NCT06569524

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

Phase II Interventional Non-alcoholic Steatohepatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: TQA2225/AP025 or TQA2225/AP025 Placebo 25mg, TQA2225/AP025 or TQA2225/AP025 Placebo 50mg.
Who it may be relevant to
Registry conditions: Non-alcoholic Steatohepatitis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Double-blind, Placebo Randomized，Phase II Study to Evaluate the Efficacy and Safety of TQA2225/AP025 in Adults With Nonalcoholic Steatohepatitis (NASH)

Overview

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)

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)

Primary outcome measures

  • To determine the effect of 25 or 50mg TQA2225 vs matching placebo on liver biopsy (NASH CRN score) at Week 48 compared with Baseline [Time frame: After week 48 of TQA2225/AP025 treatment]
Secondary outcome measures (1)
  • Adverse Events (AEs) and Serious Adverse Events (SAEs) [Time frame: Baseline to week 48]

Eligibility criteria

Inclusion criteria

  • 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).
  • Weight changes≤5% in the 6 weeks prior to randomization.
  • No qualitative change in dose for the drugs listed below:
  • Antidiabetic treatment if glucagon-like peptide-1 receptor agonists (GLP1 receptor agonists) or sodium-glucose co-transporter-2 inhibitors (SGLT2 inhibitors): for at least 3 months
  • Vitamin E (if at a dose ≥400 IU/day): for at least 6 months
  • Statins: for at least 3 months
  • Females of childbearing potential must practice a consistent and proper use of highly effective method of contraception throughout the study and for 6 month after treatment discontinuation.

Exclusion criteria

  • 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
  • Subjects with any type of active malignancy or a history of malignancy (except cervical cancer or non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma and papillary thyroid carcinoma) that has been cured for more than 5 years prior to the screening period;
  • Unable or unwilling to undergo liver biopsy according to research requirements.
  • History of weight loss surgery within 5 years (inclusive) prior to screening
  • A major surgery was performed 3 months prior to signing the Informed Consent Form (ICF), or planned during the study period.
  • Have experienced any bone trauma, fracture, or bone surgery within ≤ 2 months prior to screening.
  • When screening, according to the results of dual energy X-ray absorptiometry (DXA) examination, it meets the criteria for osteoporosis: T≤ -2.5
  • Recent history of drug abuse (defined as ≤ 2 years).
  • Patient participating in other clinical trials of drugs or medical devices within 3 months prior to screening.
  • Abnormal laboratory test values：ALT or AST >5 × ULN；Serum ALP≥2× ULN；eGFR<60mL/min；INR>1.3× ULN；platelets < LLN.
  • Pregnant or breastfeeding women.
  • Liver transplantation history or planned liver transplantation
  • Contraindications for MRI examination
  • Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

China · 53 centers
  • Lu'an Traditional Chinese Medicine Hospital — Lu'an
  • Lu'an People's Hospital — Lu'an
  • Beijing You 'an Hospital, Capital Medical University — Beijing
  • Mengchao Hepatobiliary Hospital of Fujian Medical University — Fuzhou
  • Xiamen Traditional Chinese Medicine Hospital — Xiamen
  • Wuwei Cancer Hospital of Gansu Province — Wuwei
  • Peking University Shenzhen Hospital — Shenzhen
  • Liuzhou Worker's Hospital — Liuzhou
  • … and 45 more centers

Identifiers

NCT: NCT06569524 · TQA2225-II-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗