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RECRUITING

NCT06569524

PHASE2

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

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

View on ClinicalTrials.gov

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)

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)

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-09-14

Completion Date

2027-12

Last Updated

2024-08-26

Healthy Volunteers

Conditions

Non-alcoholic Steatohepatitis

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)

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.

Locations (53)

Lu'an Traditional Chinese Medicine Hospital

Lu'an, Anhui, China

Lu'an People's Hospital

Lu'an, Anhui, China

Beijing You 'an Hospital, Capital Medical University

Beijing, Beijing Municipality, China

Mengchao Hepatobiliary Hospital of Fujian Medical University

Fuzhou, Fujian, 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

Liuchow, Guangxi, China

Liuzhou Liutie Central Hospital

Liuchow, 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

Luoyang Central Hospital

Luoyang, Henan, China

Puyang Oilfield General Hospital

Puyang, Henan, China

Henan Provincial People's Hospital

Zhengzhou, Henan, 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

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Wuxi Fifth People's Hospital

Wuxi, Jiangsu, China

Affiliated Hospital of Xuzhou Medical University

Xuzhou, Jiangsu, China

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, China

Ganzhou Fifth People's Hospital

Ganzhou, Jiangxi, China

The Second Hospital of Jilin University

Changchun, Jilin, China

The Sixth People's Hospital of Shenyang

Shenyang, Liaoning, China

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

Liaocheng People's Hospital

Liaocheng, Shandong, China

Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Shanghai Tongren Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pudong New Area Gongli Hospital

Shanghai, Shanghai Municipality, China

Shanghai Pudong Hospital

Shanghai, Shanghai Municipality, China

Shanxi Bethune Hospital

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xi 'an Jiaotong University

Xi’an, Shanxi, China

Leshan People's Hospital

Leshan, Sichuan, China

Southwest Medical University Affiliated Hospital

Luzhou, Sichuan, China

Meishan People's Hospital

Meishan, Sichuan, China

Mianyang Central Hospital

Mianyang, Sichuan, China

The First People's Hospital of Zigong City

Zigong, Sichuan, China

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Puer People's Hospital

Puer, Yunnan, China

Shulan (Hangzhou) Hospital

Hangzhou, Zhejiang, China

Rui'an People's Hospital

Hangzhou, Zhejiang, China

Ningbo Medical Treatment Center Lihuili Hospital

Ningbo, Zhejiang, China

Yiwu Central Hospital

Yiwu, Zhejiang, China

Zhoushan Hospital

Zhoushan, Zhejiang, China

Zhoukou Central Hospital

Zhoukou, Zhoukou, China

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (53)