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

Phase 2

Recruiting

• Conditions: Non-alcoholic Steatohepatitis
• Interventions: Drug: TQA2225/AP025 or TQA2225/AP025 Placebo 25mg; Drug: TQA2225/AP025 or TQA2225/AP025 Placebo 50mg

• Registration Number: NCT06569524
• Lead Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-14
• Status Verified: 2024-08
• Study First Submitted: 2024-08-22
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TQA2225/AP025 or TQA2225/AP025 Placebo 25mg	TQA2225/AP025 or TQA2225/AP025 Placebo 25mg	TQA2225/AP025 or TQA2225/AP025 Placebo administered 25mg by subcutaneous (SC) injection weekly for 48 weeks
TQA2225/AP025 or TQA2225/AP025 Placebo 50mg	TQA2225/AP025 or TQA2225/AP025 Placebo 50mg	TQA2225/AP025 or TQA2225/AP025 Placebo administered 50mg by subcutaneous (SC) injection weekly for 48 weeks

Primary Outcome Measures

Name	Time	Method
To determine the effect of 25 or 50mg TQA2225 vs matching placebo on liver biopsy (NASH CRN score) at Week 48 compared with Baseline	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

Secondary Outcome Measures

Name	Time	Method
Adverse Events (AEs) and Serious Adverse Events (SAEs)	Baseline to week 48	Number and percentage of adverse events and serious adverse events

Trial Locations

Locations (53)

Lu'an Traditional Chinese Medicine Hospital; 🇨🇳 Lu'an, Anhui, China

Lu'an People's Hospital; 🇨🇳 Lu'an, Anhui, China

Beijing You 'an Hospital, Capital Medical University; 🇨🇳 Beijing, Beijing, China

Mengchao Hepatobiliary Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China

Xiamen Traditional Chinese Medicine Hospital; 🇨🇳 Xiamen, Fujian, China

Wuwei Cancer Hospital of Gansu Province; 🇨🇳 Wuwei, Gansu, China

Peking University Shenzhen Hospital; 🇨🇳 Shenzhen, Guangdong, China

Liuzhou Worker's Hospital; 🇨🇳 Liuzhou, Guangxi, China

Liuzhou Liutie Central Hospital; 🇨🇳 Liuzhou, Guangxi, China

YuLin Red Cross Hospital; 🇨🇳 Yulin, Guangxi, China

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