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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

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

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

Efficacy and Safety of Recombinant Human FGF21-Fc Fusion Protein for Injection (TQA2225/AP025) in Adult Subjects With Non-alcoholic Steatohepatitis (NASH) (NCT06569524) is a Phase 2 interventional studying Non-alcoholic Steatohepatitis, sponsored by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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)

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Non-alcoholic Steatohepatitis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 120 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Non-alcoholic Steatohepatitis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Must be willing to participate in the study and provide written willing to sign a consent form. - Male or female aged 18 ≤ age \< 75 at the time of signing the willing to sign a consent form. - 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. Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

TQA2225/AP025 or TQA2225/AP025 Placebo 25mg

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

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)

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

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 Municipality, 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
Liuchow, Guangxi, China
Liuzhou Liutie Central Hospital
Liuchow, Guangxi, China
YuLin Red Cross Hospital
Yulin, Guangxi, China
Qingyuan Hospital Affiliated to Guangzhou Medical University (Qingyuan People's Hospital)
Qingyuan, Guangzhou, China
Baoding First Central Hospital
Baoding, Hebei, China
Cangzhou Central Hospital
Cangzhou, Hebei, China
Fifth Hospital of Shijiazhuang
Shijiazhuang, Hebei, China
Shijiazhuang Hospital of Traditional Chinese Medicine
Shijiazhuang, Hebei, China
Luoyang Central Hospital
Luoyang, Henan, China
Puyang Oilfield General Hospital
Puyang, Henan, China
Henan Provincial People's Hospital
Zhengzhou, Henan, China
Zhengzhou Sixth People's Hospital
Zhengzhou, Henan, China
Zhengzhou Third People's Hospital
Zhengzhou, Henan, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06569524), the sponsor (Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06569524 clinical trial studying?

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) The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06569524?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06569524?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06569524. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06569524. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.