Testing TQA2225/AP025 injection in adults with fatty liver inflammation
Tests an injected drug, TQA2225/AP025, against placebo in adults with NASH.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)
Key facts
- Where
- Baoding, Beijing, Cangzhou, Changchun, Changsha, Chifeng, Fuzhou, Ganzhou, Hangzhou, Jiangyin, Leshan, Liaocheng, Liuzhou, Lu'an, Luoyang, Luzhou, Meishan, Mianyang, Nanjing, Ningbo, Puer, Puyang, Qingyuan, Shanghai, Shenyang, Shenzhen, Shijiazhuang, Taiyuan, Tianjin, Wuhan, Wuwei, Wuxi, Xi’an, Xiamen, Xuzhou, Yiwu, Yueyang, Yulin, Zhengzhou, Zhenjiang, Zhoukou, Zhoushan, and Zigong, ChinaSee the 53 sites
- Phase
- Phase 2
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with non-alcoholic steatohepatitis (NASH), a fatty liver disease with liver inflammation, confirmed by a recent liver biopsy and an MRI scan.
- Age
- From 18 up to under 75 years.
- Sex
- Men and women can join.
- Disease stage
- Liver biopsy within 180 days before randomization showing fibrosis stage 1 to 3 and a NAS of ≥4, with a score of at least 1 for both lobular inflammation and ballooning degeneration. Liver fat of ≥10% on MRI-PDFF.
- Earlier treatment
- Dose of GLP1 receptor agonists or SGLT2 inhibitors must be unchanged for at least 3 months. Vitamin E at ≥400 IU/day must be unchanged for at least 6 months. Statins must be unchanged for at least 3 months. Weight change must be ≤5% in the 6 weeks before randomization.
- Biomarker or test result
- Liver fat content of ≥10% on MRI-PDFF.
Main reasons for not taking part
- Another cause of chronic liver disease besides NASH, or any history of cirrhosis
- Type 1 diabetes, or uncontrolled type 2 diabetes (hemoglobin A1c ≥9% (75 mmol/mol) or fasting blood glucose ≥13.9mmol/l (250 mg/dL))
- Uncontrolled high blood pressure (≥160/100 mm Hg)
- Pregnant or breastfeeding, or a liver transplant now or planned
- Active cancer, or past cancer with some exceptions
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06569524, who can take part
Where in China
- Baoding First Central HospitalBaoding, ChinaContact: Yingxia Hao, MasterNot yet recruiting
- Beijing You'an Hospital, Capital Medical UniversityBeijing, ChinaContact: Jing Zhang, DoctorNot yet recruiting
- Cangzhou Central HospitalCangzhou, ChinaContact: Sichen Wei, MasterNot yet recruiting
- The Second Hospital of Jilin UniversityChangchun, ChinaContact: Zhenjing Jin, DoctorNot yet recruiting
- The Second Xiangya Hospital of Central South UniversityChangsha, ChinaContact: Yongfang Jiang, DoctorNot yet recruiting
- Chifeng HospitalChifeng, ChinaContact: Ruimiao Yu, BachelorNot yet recruiting
- Mengchao Hepatobiliary Hospital of Fujian Medical UniversityFuzhou, ChinaContact: Liqing Zheng, DoctorNot yet recruiting
- Ganzhou Fifth People's HospitalGanzhou, ChinaContact: Fei Xu, DoctorNot yet recruiting
- Rui'an People's HospitalHangzhou, ChinaContact: Liang Hong, BachelorNot yet recruiting
- Shulan（Hangzhou） HospitalHangzhou, ChinaContact: Guoping Sheng, DoctorNot yet recruiting
- Jiangyin People's HospitalJiangyin, ChinaContact: Shuanghai Liu, DoctorNot yet recruiting
- Leshan People's HospitalLeshan, ChinaContact: Xianfei Zhong, MasterNot yet recruiting
- Liaocheng People's HospitalLiaocheng, ChinaContact: Sikui Wang, DoctorNot yet recruiting
- Liuzhou Liutie Central HospitalLiuzhou, ChinaContact: Jingbin Wei, MasterNot yet recruiting
- Liuzhou Worker's HospitalLiuzhou, ChinaContact: Cunli Nong, MasterNot yet recruiting
- Lu'an People's HospitalLu'an, ChinaContact: Hongnian Pan, BachelorNot yet recruiting
- Lu'an Traditional Chinese Medicine HospitalLu'an, ChinaContact: Junfeng Lu, BachelorNot yet recruiting
- Luoyang Central HospitalLuoyang, ChinaContact: Guoqiang Zhang, MasterNot yet recruiting
- Southwest Medical University Affiliated HospitalLuzhou, ChinaContact: Qing Peng, DoctorNot yet recruiting
- Meishan People's HospitalMeishan, ChinaContact: Hui Deng, BachelorNot yet recruiting
- Mianyang Central HospitalMianyang, ChinaContact: Xiaoan Li, DoctorNot yet recruiting
- Jiangsu Province HospitalNanjing, ChinaContact: Li Dong, BachelorNot yet recruiting
- Ningbo Medical Treatment Center Lihuili HospitalNingbo, ChinaContact: Lanman Xu, DoctorNot yet recruiting
- Puer People's HospitalPuer, ChinaContact: Bing Zhao, DoctorNot yet recruiting
- Puyang Oilfield General HospitalPuyang, ChinaContact: Aifeng Yang, BachelorNot yet recruiting
- Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital)Qingyuan, ChinaContact: Qiya Huang, MasterNot yet recruiting
- Ruijin Hospital, Shanghai Jiao Tong University School of MedicineShanghai, ChinaContact: Duowu Zou, DoctorNot yet recruiting
- Shanghai Pudong HospitalShanghai, ChinaContact: Wujun Xiong, DoctorNot yet recruiting
- Shanghai Pudong New Area Gongli HospitalShanghai, ChinaContact: Yihai Shi, DoctorNot yet recruiting
- Shanghai Tongren HospitalShanghai, ChinaContact: Qin Zhang, DoctorNot yet recruiting
- Shengjing Hospital affiliated to China Medical UniversityShenyang, ChinaContact: Yang Ding, DoctorNot yet recruiting
- The Sixth People's Hospital of ShenyangShenyang, ChinaContact: Rui Zhao, MasterNot yet recruiting
- Peking University Shenzhen HospitalShenzhen, ChinaContact: Yaqin Lin, BachelorNot yet recruiting
- Fifth Hospital of ShijiazhuangShijiazhuang, ChinaContact: Wenfang Yuan, MasterNot yet recruiting
- Shijiazhuang Hospital of Traditional Chinese MedicineShijiazhuang, ChinaContact: Huanwei Zheng, DoctorNot yet recruiting
- Shanxi Bethune HospitalTaiyuan, ChinaContact: Shiwei Liu, DoctorNot yet recruiting
- The First Affiliated Hospital of Tianjin University of Traditional Chinese MedicineTianjin, ChinaContact: Hui Guo, BachelorNot yet recruiting
- Huazhong University of Science Tongji Hospital, Tongji Medical CollegeWuhan, ChinaContact: Bin Cheng, DoctorNot yet recruiting
- Wuwei Cancer Hospital of Gansu ProvinceWuwei, ChinaContact: Wenhua Zhang, BachelorNot yet recruiting
- Wuxi Fifth People's HospitalWuxi, ChinaContact: Zheng Wang, DoctorNot yet recruiting
- The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaContact: Feng Ye, DoctorNot yet recruiting
- Xiamen Traditional Chinese Medicine HospitalXiamen, ChinaContact: Qingfa Ruan, MasterNot yet recruiting
- Affiliated Hospital of Xuzhou Medical UniversityXuzhou, ChinaContact: Fang Ji, DoctorNot yet recruiting
- Yiwu Central HospitalYiwu, ChinaContact: Dong Yan, DoctorNot yet recruiting
- Yueyang Central HospitalYueyang, ChinaContact: Mingjuan Yuan, MasterNot yet recruiting
- Yulin Red Cross HospitalYulin, ChinaContact: Yu Wang, MasterNot yet recruiting
- Henan Provincial People's HospitalZhengzhou, ChinaContact: Jia Shang, BachelorTaking people
- Zhengzhou Sixth People's HospitalZhengzhou, ChinaContact: Guangming Li, MasterNot yet recruiting
- Zhengzhou Third People's Hospital"Zhengzhou, ChinaContact: Dan Zhao, MasterNot yet recruiting
- Affiliated Hospital of Jiangsu UniversityZhenjiang, ChinaContact: Min Xu, DoctorNot yet recruiting
- Zhoukou Central HospitalZhoukou, ChinaContact: Junying Liu, DoctorNot yet recruiting
- Zhoushan hospitalZhoushan, ChinaContact: Qiujing Wang, MasterNot yet recruiting
- The First People's Hospital of Zigong CityZigong, ChinaContact: Chunfang You, MasterNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
- Trial code
- NCT06569524
- Record updated
- 26 August 2024
- Original description
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)Read full original descriptionShow less
A Double-blind, Placebo Randomized，Phase II Study to Evaluate the Efficacy and Safety of TQA2225/AP025 in Adults With Nonalcoholic Steatohepatitis (NASH)
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)
Inclusion: 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: 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; Patient participating in other clinical trials of drugs or medical devices within 3 months prior to screening; Liver transplantation history or planned liver transplantation; Documented causes of chronic liver disease other than NASH; Uncontrolled hypertension at Screening (values ≥160/100 mm Hg); 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; 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; Type 1 diabetes or uncontrolled Type 2 diabetes defined as:Hemoglobin A1c ≥9% at screening，Fasting blood glucose≥13.9mmol/l; Abnormal laboratory test values：ALT or AST >5 × ULN；Serum ALP≥2× ULN；eGFR<60mL/min；INR>1.3× ULN；platelets < LLN; Recent history of drug abuse (defined as ≤ 2 years); History or presence of cirrhosis; Unable or unwilling to undergo liver biopsy according to research requirements; When screening, according to the results of dual energy X-ray absorptiometry (DXA) examination, it meets the criteria for osteoporosis: T≤ -2.5; Pregnant or breastfeeding women; Contraindications for MRI examination.