Evaluating a new treatment for Non-alcoholic Steatohepatitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Henan Provincial People's Hospital
  Zhengzhou, Henan, China Recruiting
• 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

+3 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Junqi Niu, Doctor
• Email: junqiniu@aliyun.com
• Phone: 13756661205

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.