Evaluating a new treatment for Non-alcoholic Steatohepatitis

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

This study is testing a new treatment for Non-alcoholic Steatohepatitis (NASH) to see if it can improve liver health in adults.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd. (Industry-sponsored)
• Locations: 53 sites (Lu'an, Anhui and 52 other locations)
• Trial ID: NCT06569524 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial assesses the efficacy and safety of TQA2225/AP025, a recombinant human FGF21-Fc fusion protein, in adults diagnosed with Non-alcoholic Steatohepatitis (NASH). The study employs a randomized, double-blind, placebo-controlled design, where participants will receive either the treatment or a placebo in two different dosages. The trial aims to determine the impact of the drug on liver health and overall patient outcomes. Participants must meet specific eligibility criteria, including recent liver biopsy results and confirmed liver fat content.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 75 with a recent liver biopsy indicating fibrosis stage 1 to 3 and a NAS score of at least 4.

Not a fit: Patients with advanced liver disease or those not meeting the specific eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve liver health and quality of life for patients with NASH.

How similar studies have performed: While there have been studies on treatments for NASH, the specific approach of using TQA2225/AP025 is novel and has not been extensively tested.

Eligibility criteria

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.

Where this trial is running

Lu'an, Anhui and 52 other locations

• Lu'an Traditional Chinese Medicine Hospital — Lu'an, Anhui, China (Not_yet_recruiting)
• Lu'an People's Hospital — Lu'an, Anhui, China (Not_yet_recruiting)
• Beijing You 'an Hospital, Capital Medical University — Beijing, Beijing Municipality, China (Not_yet_recruiting)
• Mengchao Hepatobiliary Hospital of Fujian Medical University — Fuzhou, Fujian, China (Not_yet_recruiting)
• Xiamen Traditional Chinese Medicine Hospital — Xiamen, Fujian, China (Not_yet_recruiting)
• Wuwei Cancer Hospital of Gansu Province — Wuwei, Gansu, China (Not_yet_recruiting)
• Peking University Shenzhen Hospital — Shenzhen, Guangdong, China (Not_yet_recruiting)
• Liuzhou Worker's Hospital — Liuzhou, Guangxi, China (Not_yet_recruiting)
• Liuzhou Liutie Central Hospital — Liuzhou, Guangxi, China (Not_yet_recruiting)
• YuLin Red Cross Hospital — Yulin, Guangxi, China (Not_yet_recruiting)
• Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital) — Qingyuan, Guangzhou, China (Not_yet_recruiting)
• Baoding First Central Hospital — Baoding, Hebei, China (Not_yet_recruiting)
• Cangzhou Central Hospital — Cangzhou, Hebei, China (Not_yet_recruiting)
• Fifth Hospital of Shijiazhuang — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Shijiazhuang Hospital of Traditional Chinese Medicine — Shijiazhuang, Hebei, China (Not_yet_recruiting)
• Luoyang Central Hospital — Luoyang, Henan, China (Not_yet_recruiting)
• Puyang Oilfield General Hospital — Puyang, Henan, China (Not_yet_recruiting)
• Henan Provincial People's Hospital — Zhengzhou, Henan, China (Recruiting)
• Zhengzhou Sixth People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Zhengzhou Third People's Hospital — Zhengzhou, Henan, China (Not_yet_recruiting)
• Huazhong University of Science Tongji Hospital, Tongji Medical College — Wuhan, Hubei, China (Not_yet_recruiting)
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China (Not_yet_recruiting)
• Yueyang Central Hospital — Yueyang, Hunan, China (Not_yet_recruiting)
• Chifeng Hospital — Chifeng, Inner Mongolia, China (Not_yet_recruiting)
• Jiangyin People's Hospital — Jiangyin, Jiangsu, China (Not_yet_recruiting)
• Jiangsu Province Hospital — Nanjing, Jiangsu, China (Not_yet_recruiting)
• Wuxi Fifth People's Hospital — Wuxi, Jiangsu, China (Not_yet_recruiting)
• Affiliated Hospital of Xuzhou Medical University — Xuzhou, Jiangsu, China (Not_yet_recruiting)
• Affiliated Hospital of Jiangsu University — Zhenjiang, Jiangsu, China (Not_yet_recruiting)
• Ganzhou Fifth People's Hospital — Ganzhou, Jiangxi, China (Not_yet_recruiting)
• The Second Hospital of Jilin University — Changchun, Jilin, China (Not_yet_recruiting)
• The Sixth People's Hospital of Shenyang — Shenyang, Liaoning, China (Not_yet_recruiting)
• Shengjing Hospital Affiliated to China Medical University — Shenyang, Liaoning, China (Not_yet_recruiting)
• Liaocheng People's Hospital — Liaocheng, Shandong, China (Not_yet_recruiting)
• Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanghai Tongren Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanghai Pudong New Area Gongli Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanghai Pudong Hospital — Shanghai, Shanghai Municipality, China (Not_yet_recruiting)
• Shanxi Bethune Hospital — Taiyuan, Shanxi, China (Not_yet_recruiting)
• The First Affiliated Hospital of Xi 'an Jiaotong University — Xi’an, Shanxi, China (Not_yet_recruiting)
• Leshan People's Hospital — Leshan, Sichuan, China (Not_yet_recruiting)
• Southwest Medical University Affiliated Hospital — Luzhou, Sichuan, China (Not_yet_recruiting)
• Meishan People's Hospital — Meishan, Sichuan, China (Not_yet_recruiting)
• Mianyang Central Hospital — Mianyang, Sichuan, China (Not_yet_recruiting)
• The First People's Hospital of Zigong City — Zigong, Sichuan, China (Not_yet_recruiting)
• The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine — Tianjin, Tianjin Municipality, China (Not_yet_recruiting)
• Puer People's Hospital — Puer, Yunnan, China (Not_yet_recruiting)
• Shulan (Hangzhou) Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Rui'an People's Hospital — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Ningbo Medical Treatment Center Lihuili Hospital — Ningbo, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Junqi Niu, Doctor

Conditions Non-alcoholic Steatohepatitis