Actively Recruiting
Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2024-08-26
120
Participants Needed
53
Research Sites
219 weeks
Total Duration
On this page
AI-Summary
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)
CONDITIONS
Official Title
Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and provide written informed consent
- Male or female aged 18 to less than 75 years
- Prior liver biopsy within 180 days showing fibrosis stage 1 to 3 and NAS score of 4 or more with at least 1 in lobular inflammation and ballooning degeneration
- Liver fat content of 10% or higher confirmed by MRI-PDFF
- Weight change of 5% or less in the 6 weeks before randomization
- Stable doses of certain medications: GLP1 receptor agonists or SGLT2 inhibitors (at least 3 months), Vitamin E at 400 IU/day or less (at least 6 months), Statins (at least 3 months)
- Females of childbearing potential must consistently use effective contraception during the study and for 6 months after stopping treatment
You will not qualify if you...
- Chronic liver diseases other than NASH
- Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c 9% or higher, fasting glucose 13.9 mmol/l or higher)
- Uncontrolled high blood pressure (160/100 mm Hg or higher) at screening
- History or presence of cirrhosis
- Active malignancy or history of cancer except certain cured cancers within 5 years
- Unable or unwilling to undergo liver biopsy
- Weight loss surgery within 5 years before screening
- Major surgery within 3 months before consent or planned during study
- Bone trauma, fracture, or surgery within 2 months before screening
- Osteoporosis based on DXA results (T score -2.5 or lower)
- Drug abuse within 2 years
- Participation in other drug or device trials within 3 months before screening
- Abnormal lab values: ALT or AST more than 5 times upper limit, ALP 2 times or more upper limit, eGFR below 60 mL/min, INR above 1.3 times upper limit, low platelets
- Pregnant or breastfeeding women
- History or planned liver transplantation
- Contraindications to MRI
- Any condition that may interfere with study compliance or outcomes
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 53 locations
1
Lu'an Traditional Chinese Medicine Hospital
Lu'an, Anhui, China, 237000
Not Yet Recruiting
2
Lu'an People's Hospital
Lu'an, Anhui, China, 237121
Not Yet Recruiting
3
Beijing You 'an Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100069
Not Yet Recruiting
4
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350025
Not Yet Recruiting
5
Xiamen Traditional Chinese Medicine Hospital
Xiamen, Fujian, China, 361000
Not Yet Recruiting
6
Wuwei Cancer Hospital of Gansu Province
Wuwei, Gansu, China, 100069
Not Yet Recruiting
7
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Not Yet Recruiting
8
Liuzhou Worker's Hospital
Liuzhou, Guangxi, China, 545005
Not Yet Recruiting
9
Liuzhou Liutie Central Hospital
Liuzhou, Guangxi, China, 545007
Not Yet Recruiting
10
YuLin Red Cross Hospital
Yulin, Guangxi, China, 537099
Not Yet Recruiting
11
Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital)
Qingyuan, Guangzhou, China, 511436
Not Yet Recruiting
12
Baoding First Central Hospital
Baoding, Hebei, China, 071030
Not Yet Recruiting
13
Cangzhou Central Hospital
Cangzhou, Hebei, China, 061012
Not Yet Recruiting
14
Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, China, 050024
Not Yet Recruiting
15
Shijiazhuang Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China, 052360
Not Yet Recruiting
16
Luoyang Central Hospital
Luoyang, Henan, China, 471000
Not Yet Recruiting
17
Puyang Oilfield General Hospital
Puyang, Henan, China, 457001
Not Yet Recruiting
18
Henan Provincial People's Hospital
Zhengzhou, Henan, China, 450000
Actively Recruiting
19
Zhengzhou Sixth People's Hospital
Zhengzhou, Henan, China, 450015
Not Yet Recruiting
20
Zhengzhou Third People's Hospital
Zhengzhou, Henan, China, 450099
Not Yet Recruiting
21
Huazhong University of Science Tongji Hospital, Tongji Medical College
Wuhan, Hubei, China, 448000
Not Yet Recruiting
22
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410000
Not Yet Recruiting
23
Yueyang Central Hospital
Yueyang, Hunan, China, 414020
Not Yet Recruiting
24
Chifeng Hospital
Chifeng, Inner Mongolia, China, 024099
Not Yet Recruiting
25
Jiangyin People's Hospital
Jiangyin, Jiangsu, China, 214499
Not Yet Recruiting
26
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210003
Not Yet Recruiting
27
Wuxi Fifth People's Hospital
Wuxi, Jiangsu, China, 214001
Not Yet Recruiting
28
Affiliated Hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China, 221000
Not Yet Recruiting
29
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, China, 212001
Not Yet Recruiting
30
Ganzhou Fifth People's Hospital
Ganzhou, Jiangxi, China, 341099
Not Yet Recruiting
31
The Second Hospital of Jilin University
Changchun, Jilin, China, 130041
Not Yet Recruiting
32
The Sixth People's Hospital of Shenyang
Shenyang, Liaoning, China, 110000
Not Yet Recruiting
33
Shengjing Hospital Affiliated to China Medical University
Shenyang, Liaoning, China, 110022
Not Yet Recruiting
34
Liaocheng People's Hospital
Liaocheng, Shandong, China, 252000
Not Yet Recruiting
35
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, China, 200030
Not Yet Recruiting
36
Shanghai Tongren Hospital
Shanghai, Shanghai Municipality, China, 200050
Not Yet Recruiting
37
Shanghai Pudong New Area Gongli Hospital
Shanghai, Shanghai Municipality, China, 200135
Not Yet Recruiting
38
Shanghai Pudong Hospital
Shanghai, Shanghai Municipality, China, 201399
Not Yet Recruiting
39
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 050081
Not Yet Recruiting
40
The First Affiliated Hospital of Xi 'an Jiaotong University
Xi’an, Shanxi, China, 710000
Not Yet Recruiting
41
Leshan People's Hospital
Leshan, Sichuan, China, 614099
Not Yet Recruiting
42
Southwest Medical University Affiliated Hospital
Luzhou, Sichuan, China, 646099
Not Yet Recruiting
43
Meishan People's Hospital
Meishan, Sichuan, China, 620000
Not Yet Recruiting
44
Mianyang Central Hospital
Mianyang, Sichuan, China, 621099
Not Yet Recruiting
45
The First People's Hospital of Zigong City
Zigong, Sichuan, China, 643000
Not Yet Recruiting
46
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality, China, 300193
Not Yet Recruiting
47
Puer People's Hospital
Puer, Yunnan, China, 665099
Not Yet Recruiting
48
Shulan (Hangzhou) Hospital
Hangzhou, Zhejiang, China, 310022
Not Yet Recruiting
49
Rui'an People's Hospital
Hangzhou, Zhejiang, China, 325200
Not Yet Recruiting
50
Ningbo Medical Treatment Center Lihuili Hospital
Ningbo, Zhejiang, China, 315040
Not Yet Recruiting
51
Yiwu Central Hospital
Yiwu, Zhejiang, China, 322099
Not Yet Recruiting
52
Zhoushan Hospital
Zhoushan, Zhejiang, China, 316100
Not Yet Recruiting
53
Zhoukou Central Hospital
Zhoukou, Zhoukou, China, 466099
Not Yet Recruiting
Research Team
J
Junqi Niu, Doctor
CONTACT
Z
Zujiang Yu, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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