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Clinical Trials in China / NCT06569524
Recruiting Phase 2

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

NCT06569524 · tracked via the Priya Life Science China tracker
Sponsor
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Phase
Phase 2
Started
2023-09-14
Last updated
2024-08-26

Condition(s) studied

Non-alcoholic Steatohepatitis

Investigational drug(s) / intervention(s)

TQA2225/AP025 or TQA2225/AP025 Placebo 25mgTQA2225/AP025 or TQA2225/AP025 Placebo 50mg

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

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

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)

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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: 1. 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 2. Vitamin E (if at a dose ≥400 IU/day): for at least 6 months 3. 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.

Primary outcome measure(s)

Trial sites (53)

FacilityCityRegionStatus
Lu'an Traditional Chinese Medicine Hospital Lu'an Anhui Not Yet Recruiting
Lu'an People's Hospital Lu'an Anhui Not Yet Recruiting
Beijing You 'an Hospital, Capital Medical University Beijing Beijing Municipality Not Yet Recruiting
Mengchao Hepatobiliary Hospital of Fujian Medical University Fuzhou Fujian Not Yet Recruiting
Xiamen Traditional Chinese Medicine Hospital Xiamen Fujian Not Yet Recruiting
Wuwei Cancer Hospital of Gansu Province Wuwei Gansu Not Yet Recruiting
Peking University Shenzhen Hospital Shenzhen Guangdong Not Yet Recruiting
Liuzhou Worker's Hospital Liuzhou Guangxi Not Yet Recruiting
Liuzhou Liutie Central Hospital Liuzhou Guangxi Not Yet Recruiting
YuLin Red Cross Hospital Yulin Guangxi Not Yet Recruiting
Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital) Qingyuan Guangzhou Not Yet Recruiting
Baoding First Central Hospital Baoding Hebei Not Yet Recruiting
Cangzhou Central Hospital Cangzhou Hebei Not Yet Recruiting
Fifth Hospital of Shijiazhuang Shijiazhuang Hebei Not Yet Recruiting
Shijiazhuang Hospital of Traditional Chinese Medicine Shijiazhuang Hebei Not Yet Recruiting
Luoyang Central Hospital Luoyang Henan Not Yet Recruiting
Puyang Oilfield General Hospital Puyang Henan Not Yet Recruiting
Henan Provincial People's Hospital Zhengzhou Henan Recruiting
Zhengzhou Sixth People's Hospital Zhengzhou Henan Not Yet Recruiting
Zhengzhou Third People's Hospital Zhengzhou Henan Not Yet Recruiting
Huazhong University of Science Tongji Hospital, Tongji Medical College Wuhan Hubei Not Yet Recruiting
The Second Xiangya Hospital of Central South University Changsha Hunan Not Yet Recruiting
Yueyang Central Hospital Yueyang Hunan Not Yet Recruiting
Chifeng Hospital Chifeng Inner Mongolia Not Yet Recruiting
Jiangyin People's Hospital Jiangyin Jiangsu Not Yet Recruiting
Jiangsu Province Hospital Nanjing Jiangsu Not Yet Recruiting
Wuxi Fifth People's Hospital Wuxi Jiangsu Not Yet Recruiting
Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu Not Yet Recruiting
Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu Not Yet Recruiting
Ganzhou Fifth People's Hospital Ganzhou Jiangxi Not Yet Recruiting
The Second Hospital of Jilin University Changchun Jilin Not Yet Recruiting
The Sixth People's Hospital of Shenyang Shenyang Liaoning Not Yet Recruiting
Shengjing Hospital Affiliated to China Medical University Shenyang Liaoning Not Yet Recruiting
Liaocheng People's Hospital Liaocheng Shandong Not Yet Recruiting
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Not Yet Recruiting
Shanghai Tongren Hospital Shanghai Shanghai Municipality Not Yet Recruiting
Shanghai Pudong New Area Gongli Hospital Shanghai Shanghai Municipality Not Yet Recruiting
Shanghai Pudong Hospital Shanghai Shanghai Municipality Not Yet Recruiting
Shanxi Bethune Hospital Taiyuan Shanxi Not Yet Recruiting
The First Affiliated Hospital of Xi 'an Jiaotong University Xi’an Shanxi Not Yet Recruiting

+ 13 more sites — see the full list on the official registry below.

More Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06569524 on ClinicalTrials.gov ↗ ← All trials in China