Status:
RECRUITING
Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH)
Lead Sponsor:
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Conditions:
Non-alcoholic Steatohepatitis
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 14 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06569524
Start Date
September 14 2023
End Date
December 1 2027
Last Update
August 26 2024
Active Locations (53)
Enter a location and click search to find clinical trials sorted by distance.
1
Lu'an Traditional Chinese Medicine Hospital
Lu'an, Anhui, China, 237000
2
Lu'an People's Hospital
Lu'an, Anhui, China, 237121
3
Beijing You 'an Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100069
4
Mengchao Hepatobiliary Hospital of Fujian Medical University
Fuzhou, Fujian, China, 350025