Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)
Recruiting · NCT06569524 · Interventional (participants receive a specific treatment) · Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
TQA2225/AP025 or TQA2225/AP025 Placebo 25mgTQA2225/AP025 or TQA2225/AP025 Placebo 50mg
What this trial is about
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)
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
53 locations listed.
- 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 - 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
- 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