Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)
A Double-blind, Placebo Randomized，Phase II Study to Evaluate the Efficacy and Safety of TQA2225/AP025 in Adults With Nonalcoholic Steatohepatitis (NASH)
1 other identifier
interventional
120
1 country
53
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Sep 2023
Typical duration for phase_2
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 14, 2023
CompletedFirst Submitted
Initial submission to the registry
August 22, 2024
CompletedFirst Posted
Study publicly available on registry
August 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2027
August 26, 2024
August 1, 2024
3.2 years
August 22, 2024
August 22, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
To determine the effect of 25 or 50mg TQA2225 vs matching placebo on liver biopsy (NASH CRN score) at Week 48 compared with Baseline
1. Proportion with resolution of NASH (ballooning 0, inflammation 0,1) associated with at least 2-point reduction in NAFLD Activity Score (NAS) without worsening of fibrosis stage OR 2. Proportion with at least a 1-point improvement in fibrosis stage with no worsening of NAS
After week 48 of TQA2225/AP025 treatment
Secondary Outcomes (1)
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Baseline to week 48
Study Arms (2)
TQA2225/AP025 or TQA2225/AP025 Placebo 25mg
EXPERIMENTALTQA2225/AP025 or TQA2225/AP025 Placebo administered 25mg by subcutaneous (SC) injection weekly for 48 weeks
TQA2225/AP025 or TQA2225/AP025 Placebo 50mg
EXPERIMENTALTQA2225/AP025 or TQA2225/AP025 Placebo administered 50mg by subcutaneous (SC) injection weekly for 48 weeks
Interventions
To evaluate the efficacy and safety of TQA2225/AP025 (25mg) in patients with Non-Alcoholic Steatohepatitis (NASH)
To evaluate the efficacy and safety of TQA2225/AP025 (50mg) in patients with Non-Alcoholic Steatohepatitis (NASH)
Eligibility Criteria
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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Lu'an Traditional Chinese Medicine Hospital
Lu'an, Anhui, 237000, China
Lu'an People's Hospital
Lu'an, Anhui, 237121, China
Beijing You 'an Hospital, Capital Medical University
Beijing, Beijing Municipality, 100069, China
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, 350025, China
Xiamen Traditional Chinese Medicine Hospital
Xiamen, Fujian, 361000, China
Wuwei Cancer Hospital of Gansu Province
Wuwei, Gansu, 100069, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
Liuzhou Worker's Hospital
Liuchow, Guangxi, 545005, China
Liuzhou Liutie Central Hospital
Liuchow, Guangxi, 545007, China
YuLin Red Cross Hospital
Yulin, Guangxi, 537099, China
Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital)
Qingyuan, Guangzhou, 511436, China
Baoding First Central Hospital
Baoding, Hebei, 071030, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061012, China
Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, 050024, China
Shijiazhuang Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, 052360, China
Luoyang Central Hospital
Luoyang, Henan, 471000, China
Puyang Oilfield General Hospital
Puyang, Henan, 457001, China
Henan Provincial People's Hospital
Zhengzhou, Henan, 450000, China
Zhengzhou Sixth People's Hospital
Zhengzhou, Henan, 450015, China
Zhengzhou Third People's Hospital
Zhengzhou, Henan, 450099, China
Huazhong University of Science Tongji Hospital, Tongji Medical College
Wuhan, Hubei, 448000, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410000, China
Yueyang Central Hospital
Yueyang, Hunan, 414020, China
Chifeng Hospital
Chifeng, Inner Mongolia, 024099, China
Jiangyin People's Hospital
Jiangyin, Jiangsu, 214499, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210003, China
Wuxi Fifth People's Hospital
Wuxi, Jiangsu, 214001, China
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, 221000, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001, China
Ganzhou Fifth People's Hospital
Ganzhou, Jiangxi, 341099, China
The Second Hospital of Jilin University
Changchun, Jilin, 130041, China
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, 110000, China
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, 110022, China
Liaocheng People's Hospital
Liaocheng, Shandong, 252000, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200030, China
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, 200050, China
Shanghai Pudong New Area Gongli Hospital
Shanghai, Shanghai Municipality, 200135, China
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, 201399, China
Shanxi Bethune Hospital
Taiyuan, Shanxi, 050081, China
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, 710000, China
Leshan People's Hospital
Leshan, Sichuan, 614099, China
Southwest Medical University Affiliated Hospital
Luzhou, Sichuan, 646099, China
Meishan People's Hospital
Meishan, Sichuan, 620000, China
Mianyang Central Hospital
Mianyang, Sichuan, 621099, China
The First People's Hospital of Zigong City
Zigong, Sichuan, 643000, China
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, 300193, China
Puer People's Hospital
Puer, Yunnan, 665099, China
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, 310022, China
Rui'an People's Hospital
Hangzhou, Zhejiang, 325200, China
Ningbo Medical Treatment Center Lihuili Hospital
Ningbo, Zhejiang, 315040, China
Yiwu Central Hospital
Yiwu, Zhejiang, 322099, China
Zhoushan Hospital
Zhoushan, Zhejiang, 316100, China
Zhoukou Central Hospital
Zhoukou, Zhoukou, 466099, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 22, 2024
First Posted
August 26, 2024
Study Start
September 14, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Last Updated
August 26, 2024
Record last verified: 2024-08