A Double-blind, Placebo Randomized,Phase II Study to Evaluate the Efficacy and Safety of TQA2225/AP025 in Adults With Nonalcoholic Steatohepatitis (NASH)

Status: Recruiting
Location: See all (53) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Baoding First Central Hospital
NOT_YET_RECRUITING
Baoding
Beijing You 'an Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Cangzhou Central Hospital
NOT_YET_RECRUITING
Cangzhou
The Second Hospital of Jilin University
NOT_YET_RECRUITING
Changchun
The Second Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Chifeng Hospital
NOT_YET_RECRUITING
Chifeng
Mengchao Hepatobiliary Hospital of Fujian Medical University
NOT_YET_RECRUITING
Fuzhou
Ganzhou Fifth People's Hospital
NOT_YET_RECRUITING
Ganzhou
Rui'an People's Hospital
NOT_YET_RECRUITING
Hangzhou
Shulan (Hangzhou) Hospital
NOT_YET_RECRUITING
Hangzhou
Jiangyin People's Hospital
NOT_YET_RECRUITING
Jiangyin
Leshan People's Hospital
NOT_YET_RECRUITING
Leshan
Liaocheng People's Hospital
NOT_YET_RECRUITING
Liaocheng
Liuzhou Liutie Central Hospital
NOT_YET_RECRUITING
Liuzhou
Liuzhou Worker's Hospital
NOT_YET_RECRUITING
Liuzhou
Lu'an People's Hospital
NOT_YET_RECRUITING
Lu'an
Lu'an Traditional Chinese Medicine Hospital
NOT_YET_RECRUITING
Lu'an
Luoyang Central Hospital
NOT_YET_RECRUITING
Luoyang
Southwest Medical University Affiliated Hospital
NOT_YET_RECRUITING
Luzhou
Meishan People's Hospital
NOT_YET_RECRUITING
Meishan
Mianyang Central Hospital
NOT_YET_RECRUITING
Mianyang
Jiangsu Province Hospital
NOT_YET_RECRUITING
Nanjing
Ningbo Medical Treatment Center Lihuili Hospital
NOT_YET_RECRUITING
Ningbo
Puer People's Hospital
NOT_YET_RECRUITING
Puer
Puyang Oilfield General Hospital
NOT_YET_RECRUITING
Puyang
Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital)
NOT_YET_RECRUITING
Qingyuan
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
NOT_YET_RECRUITING
Shanghai
Shanghai Pudong Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Pudong New Area Gongli Hospital
NOT_YET_RECRUITING
Shanghai
Shanghai Tongren Hospital
NOT_YET_RECRUITING
Shanghai
Shengjing Hospital Affiliated to China Medical University
NOT_YET_RECRUITING
Shenyang
The Sixth People's Hospital of Shenyang
NOT_YET_RECRUITING
Shenyang
Peking University Shenzhen Hospital
NOT_YET_RECRUITING
Shenzhen
Fifth Hospital of Shijiazhuang
NOT_YET_RECRUITING
Shijiazhuang
Shijiazhuang Hospital of Traditional Chinese Medicine
NOT_YET_RECRUITING
Shijiazhuang
Shanxi Bethune Hospital
NOT_YET_RECRUITING
Taiyuan
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
NOT_YET_RECRUITING
Tianjin
Huazhong University of Science Tongji Hospital, Tongji Medical College
NOT_YET_RECRUITING
Wuhan
Wuwei Cancer Hospital of Gansu Province
NOT_YET_RECRUITING
Wuwei
Wuxi Fifth People's Hospital
NOT_YET_RECRUITING
Wuxi
The First Affiliated Hospital of Xi 'an Jiaotong University
NOT_YET_RECRUITING
Xi’an
Xiamen Traditional Chinese Medicine Hospital
NOT_YET_RECRUITING
Xiamen
Affiliated Hospital of Xuzhou Medical University
NOT_YET_RECRUITING
Xuzhou
Yiwu Central Hospital
NOT_YET_RECRUITING
Yiwu
Yueyang Central Hospital
NOT_YET_RECRUITING
Yueyang
YuLin Red Cross Hospital
NOT_YET_RECRUITING
Yulin
Henan Provincial People's Hospital
RECRUITING
Zhengzhou
Zhengzhou Sixth People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Zhengzhou Third People's Hospital
NOT_YET_RECRUITING
Zhengzhou
Affiliated Hospital of Jiangsu University
NOT_YET_RECRUITING
Zhenjiang
Zhoukou Central Hospital
NOT_YET_RECRUITING
Zhoukou
Zhoushan Hospital
NOT_YET_RECRUITING
Zhoushan
The First People's Hospital of Zigong City
NOT_YET_RECRUITING
Zigong
Contact Information
Primary
Junqi Niu, Doctor
junqiniu@aliyun.com
13756661205
Backup
Zujiang Yu, Doctor
johnyuem@zzu.edu.cn
18603710022
Time Frame
Start Date: 2023-09-14
Estimated Completion Date: 2027-12
Participants
Target number of participants: 120
Treatments
Experimental: TQA2225/AP025 or TQA2225/AP025 Placebo 25mg
TQA2225/AP025 or TQA2225/AP025 Placebo administered 25mg by subcutaneous (SC) injection weekly for 48 weeks
Experimental: TQA2225/AP025 or TQA2225/AP025 Placebo 50mg
TQA2225/AP025 or TQA2225/AP025 Placebo administered 50mg by subcutaneous (SC) injection weekly for 48 weeks
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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