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

Официальное название

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

Обзор

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)

Вмешательства

• Препарат TQA2225/AP025 or TQA2225/AP025 Placebo 25mg
  To evaluate the efficacy and safety of TQA2225/AP025 (25mg) in patients with Non-Alcoholic Steatohepatitis (NASH)
• Препарат TQA2225/AP025 or TQA2225/AP025 Placebo 50mg
  To evaluate the efficacy and safety of TQA2225/AP025 (50mg) in patients with Non-Alcoholic Steatohepatitis (NASH)

Первичные конечные точки

• To determine the effect of 25 or 50mg TQA2225 vs matching placebo on liver biopsy (NASH CRN score) at Week 48 compared with Baseline [Срок оценки: After week 48 of TQA2225/AP025 treatment]

Вторичные конечные точки (1)

• Adverse Events (AEs) and Serious Adverse Events (SAEs) [Срок оценки: Baseline to week 48]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 53 центра

• Lu'an Traditional Chinese Medicine Hospital — Lu'an
• Lu'an People's Hospital — Lu'an
• Beijing You 'an Hospital, Capital Medical University — Пекин
• Mengchao Hepatobiliary Hospital of Fujian Medical University — Фучжоу
• Xiamen Traditional Chinese Medicine Hospital — Xiamen
• Wuwei Cancer Hospital of Gansu Province — Wuwei
• Peking University Shenzhen Hospital — Шэньчжэнь
• Liuzhou Worker's Hospital — Liuzhou
• … и ещё 45 центров

Идентификаторы

NCT: NCT06569524 · TQA2225-II-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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