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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Non-alcoholic Steatohepatitis

In brief

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)

Key facts

Study ID

NCT06569524

Run by

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

People needed

120

Starts

2023-09-14

Expected to finish

2027-12-01

Last updated by the study team

2024-08-26

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Henan Provincial People's Hospital — Zhengzhou, Henan, China (enrolling)
• Beijing You 'an Hospital, Capital Medical University — Beijing, Beijing Municipality, China
• Luoyang Central Hospital — Luoyang, Henan, China
• Xiamen Traditional Chinese Medicine Hospital — Xiamen, Fujian, China
• Wuwei Cancer Hospital of Gansu Province — Wuwei, Gansu, China
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China
• Liuzhou Worker's Hospital — Liuzhou, Guangxi, China
• Liuzhou Liutie Central Hospital — Liuzhou, Guangxi, China
• YuLin Red Cross Hospital — Yulin, Guangxi, China
• Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital) — Qingyuan, Guangzhou, China
• Baoding First Central Hospital — Baoding, Hebei, China
• Cangzhou Central Hospital — Cangzhou, Hebei, China
• Fifth Hospital of Shijiazhuang — Shijiazhuang, Hebei, China
• Shijiazhuang Hospital of Traditional Chinese Medicine — Shijiazhuang, Hebei, China
• Mengchao Hepatobiliary Hospital of Fujian Medical University — Fuzhou, Fujian, China
• Puyang Oilfield General Hospital — Puyang, Henan, China
• Lu'an People's Hospital — Lu'an, Anhui, China
• Zhengzhou Sixth People's Hospital — Zhengzhou, Henan, China
• Zhengzhou Third People's Hospital — Zhengzhou, Henan, China
• Huazhong University of Science Tongji Hospital, Tongji Medical College — Wuhan, Hubei, China
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China
• Yueyang Central Hospital — Yueyang, Hunan, China
• Chifeng Hospital — Chifeng, Inner Mongolia, China
• Jiangyin People's Hospital — Jiangyin, Jiangsu, China
• Lu'an Traditional Chinese Medicine Hospital — Lu'an, Anhui, China

Full record on ClinicalTrials.gov

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