Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)

August 22, 2024 updated by: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

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)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Anhui
      • Lu'an, Anhui, China, 237000
        • Not yet recruiting
        • Lu'an Traditional Chinese Medicine Hospital
        • Contact:
      • Lu'an, Anhui, China, 237121
        • Not yet recruiting
        • Lu'an People's Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100069
        • Not yet recruiting
        • Beijing You 'an Hospital, Capital Medical University
        • Contact:
    • Fujian
      • Fuzhou, Fujian, China, 350025
        • Not yet recruiting
        • Mengchao Hepatobiliary Hospital of Fujian Medical University
        • Contact:
          • Liqing Zheng, Doctor
          • Phone Number: 15305918043
          • Email: wom70@163.com
      • Xiamen, Fujian, China, 361000
        • Not yet recruiting
        • Xiamen Traditional Chinese Medicine Hospital
        • Contact:
    • Gansu
      • Wuwei, Gansu, China, 100069
        • Not yet recruiting
        • Wuwei Cancer Hospital of Gansu Province
        • Contact:
    • Guangdong
      • Shenzhen, Guangdong, China, 518036
        • Not yet recruiting
        • Peking University Shenzhen Hospital
        • Contact:
    • Guangxi
      • Liuzhou, Guangxi, China, 545005
        • Not yet recruiting
        • Liuzhou Worker's Hospital
        • Contact:
      • Liuzhou, Guangxi, China, 545007
        • Not yet recruiting
        • Liuzhou Liutie Central Hospital
        • Contact:
      • Yulin, Guangxi, China, 537099
        • Not yet recruiting
        • Yulin Red Cross Hospital
        • Contact:
    • Guangzhou
      • Qingyuan, Guangzhou, China, 511436
        • Not yet recruiting
        • Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital)
        • Contact:
    • Hebei
      • Baoding, Hebei, China, 071030
        • Not yet recruiting
        • Baoding First Central Hospital
        • Contact:
      • Cangzhou, Hebei, China, 061012
        • Not yet recruiting
        • Cangzhou Central Hospital
        • Contact:
      • Shijiazhuang, Hebei, China, 050024
        • Not yet recruiting
        • Fifth Hospital of Shijiazhuang
        • Contact:
      • Shijiazhuang, Hebei, China, 052360
        • Not yet recruiting
        • Shijiazhuang Hospital of Traditional Chinese Medicine
        • Contact:
    • Henan
      • Luoyang, Henan, China, 471000
        • Not yet recruiting
        • Luoyang Central Hospital
        • Contact:
      • Puyang, Henan, China, 457001
        • Not yet recruiting
        • Puyang Oilfield General Hospital
        • Contact:
          • Aifeng Yang, Bachelor
          • Phone Number: 13721756703
          • Email: w95159@163.com
      • Zhengzhou, Henan, China, 450000
        • Recruiting
        • Henan Provincial People's Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450015
        • Not yet recruiting
        • Zhengzhou Sixth People's Hospital
        • Contact:
      • Zhengzhou, Henan, China, 450099
        • Not yet recruiting
        • Zhengzhou Third People's Hospital
        • Contact:
    • Hubei
      • Wuhan, Hubei, China, 448000
        • Not yet recruiting
        • Huazhong University of Science Tongji Hospital, Tongji Medical College
        • Contact:
    • Hunan
      • Changsha, Hunan, China, 410000
        • Not yet recruiting
        • The Second Xiangya Hospital of Central South University
        • Contact:
      • Yueyang, Hunan, China, 414020
        • Not yet recruiting
        • Yueyang Central Hospital
        • Contact:
    • Inner Mongolia
      • Chifeng, Inner Mongolia, China, 024099
        • Not yet recruiting
        • Chifeng Hospital
        • Contact:
    • Jiangsu
      • Jiangyin, Jiangsu, China, 214499
        • Not yet recruiting
        • Jiangyin People's Hospital
        • Contact:
      • Nanjing, Jiangsu, China, 210003
        • Not yet recruiting
        • Jiangsu Province Hospital
        • Contact:
      • Wuxi, Jiangsu, China, 214001
        • Not yet recruiting
        • Wuxi Fifth People's Hospital
        • Contact:
      • Xuzhou, Jiangsu, China, 221000
        • Not yet recruiting
        • Affiliated Hospital of Xuzhou Medical University
        • Contact:
      • Zhenjiang, Jiangsu, China, 212001
        • Not yet recruiting
        • Affiliated Hospital of Jiangsu University
        • Contact:
    • Jiangxi
      • Ganzhou, Jiangxi, China, 341099
        • Not yet recruiting
        • Ganzhou Fifth People's Hospital
        • Contact:
    • Jilin
      • Changchun, Jilin, China, 130041
        • Not yet recruiting
        • The Second Hospital of Jilin University
        • Contact:
    • Liaoning
      • Shenyang, Liaoning, China, 110000
        • Not yet recruiting
        • The Sixth People's Hospital of Shenyang
        • Contact:
      • Shenyang, Liaoning, China, 110022
        • Not yet recruiting
        • Shengjing Hospital affiliated to China Medical University
        • Contact:
    • Shandong
      • Liaocheng, Shandong, China, 252000
        • Not yet recruiting
        • Liaocheng People's Hospital
        • Contact:
    • Shanghai
      • Shanghai, Shanghai, China, 200030
        • Not yet recruiting
        • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
        • Contact:
      • Shanghai, Shanghai, China, 200050
        • Not yet recruiting
        • Shanghai Tongren Hospital
        • Contact:
          • Qin Zhang, Doctor
          • Phone Number: 021-52039999-79305
          • Email: gcpjgb@163.com
      • Shanghai, Shanghai, China, 200135
        • Not yet recruiting
        • Shanghai Pudong New Area Gongli Hospital
        • Contact:
      • Shanghai, Shanghai, China, 201399
        • Not yet recruiting
        • Shanghai Pudong Hospital
        • Contact:
    • Shanxi
      • Taiyuan, Shanxi, China, 050081
        • Not yet recruiting
        • Shanxi Bethune Hospital
        • Contact:
      • Xi'an, Shanxi, China, 710000
        • Not yet recruiting
        • The First Affiliated Hospital of Xi 'an Jiaotong University
        • Contact:
    • Sichuan
      • Leshan, Sichuan, China, 614099
        • Not yet recruiting
        • Leshan People's Hospital
        • Contact:
      • Luzhou, Sichuan, China, 646099
        • Not yet recruiting
        • Southwest Medical University Affiliated Hospital
        • Contact:
        • Contact:
      • Meishan, Sichuan, China, 620000
        • Not yet recruiting
        • Meishan People's Hospital
        • Contact:
      • Mianyang, Sichuan, China, 621099
        • Not yet recruiting
        • Mianyang Central Hospital
        • Contact:
      • Zigong, Sichuan, China, 643000
        • Not yet recruiting
        • The First People's Hospital of Zigong City
        • Contact:
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China, 300193
        • Not yet recruiting
        • The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
        • Contact:
    • Yunnan
      • Puer, Yunnan, China, 665099
        • Not yet recruiting
        • Puer People's Hospital
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310022
        • Not yet recruiting
        • Shulan (Hangzhou) Hospital
        • Contact:
      • Hangzhou, Zhejiang, China, 325200
        • Not yet recruiting
        • Rui'an People's Hospital
        • Contact:
      • Ningbo, Zhejiang, China, 315040
        • Not yet recruiting
        • Ningbo Medical Treatment Center Lihuili Hospital
        • Contact:
      • Yiwu, Zhejiang, China, 322099
        • Not yet recruiting
        • Yiwu Central Hospital
        • Contact:
      • Zhoushan, Zhejiang, China, 316100
        • Not yet recruiting
        • Zhoushan Hospital
        • Contact:
    • Zhoukou
      • Zhoukou, Zhoukou, China, 466099
        • Not yet recruiting
        • Zhoukou Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

    1. 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
    2. Vitamin E (if at a dose ≥400 IU/day): for at least 6 months
    3. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TQA2225/AP025 or TQA2225/AP025 Placebo 25mg
TQA2225/AP025 or TQA2225/AP025 Placebo administered 25mg by subcutaneous (SC) injection weekly for 48 weeks
Drug: TQA2225/AP025 or TQA2225/AP025 Placebo 25mg
To evaluate the efficacy and safety of TQA2225/AP025 (25mg) in patients with Non-Alcoholic Steatohepatitis (NASH)
Experimental: TQA2225/AP025 or TQA2225/AP025 Placebo 50mg
TQA2225/AP025 or TQA2225/AP025 Placebo administered 50mg by subcutaneous (SC) injection weekly for 48 weeks
Drug: TQA2225/AP025 or TQA2225/AP025 Placebo 50mg
To evaluate the efficacy and safety of TQA2225/AP025 (50mg) in patients with Non-Alcoholic Steatohepatitis (NASH)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To determine the effect of 25 or 50mg TQA2225 vs matching placebo on liver biopsy (NASH CRN score) at Week 48 compared with Baseline
Time Frame: After week 48 of TQA2225/AP025 treatment
  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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline to week 48
Number and percentage of adverse events and serious adverse events
Baseline to week 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 14, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

August 22, 2024

First Submitted That Met QC Criteria

August 22, 2024

First Posted (Actual)

August 26, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TQA2225-II-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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