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Efficacy and Safety of Recomb...

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

Last Updated: 2024-08-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-14

Study Completion Date

2027-12-31

Brief Summary

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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)

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Detailed Description

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Conditions

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Non-alcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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TQA2225/AP025 or TQA2225/AP025 Placebo 25mg

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

Group Type EXPERIMENTAL

TQA2225/AP025 or TQA2225/AP025 Placebo 25mg

Intervention Type DRUG

To evaluate the efficacy and safety of TQA2225/AP025 (25mg) in patients with Non-Alcoholic Steatohepatitis (NASH)

TQA2225/AP025 or TQA2225/AP025 Placebo 50mg

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

Group Type EXPERIMENTAL

TQA2225/AP025 or TQA2225/AP025 Placebo 50mg

Intervention Type DRUG

To evaluate the efficacy and safety of TQA2225/AP025 (50mg) in patients with Non-Alcoholic Steatohepatitis (NASH)

Interventions

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TQA2225/AP025 or TQA2225/AP025 Placebo 25mg

To evaluate the efficacy and safety of TQA2225/AP025 (25mg) in patients with Non-Alcoholic Steatohepatitis (NASH)

Intervention Type 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)

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Locations

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