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)
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)
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.
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)
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