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

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.53 sites in 1 country120 target enrollmentSeptember 14, 2023

ConditionsNon-alcoholic Steatohepatitis

InterventionsTQA2225/AP025 or TQA2225/AP025 Placebo 25mg TQA2225/AP025 or TQA2225/AP025 Placebo 50mg

Overview

Phase: Phase 2
Intervention: TQA2225/AP025 or TQA2225/AP025 Placebo 25mg
Conditions: Non-alcoholic Steatohepatitis
Sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Enrollment: 120
Locations: 53
Primary Endpoint: To determine the effect of 25 or 50mg TQA2225 vs matching placebo on liver biopsy (NASH CRN score) at Week 48 compared with Baseline
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

September 14, 2023

End Date

December 2027

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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:
•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 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

Arms & Interventions

TQA2225/AP025 or TQA2225/AP025 Placebo 25mg

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

Intervention: TQA2225/AP025 or TQA2225/AP025 Placebo 25mg

TQA2225/AP025 or TQA2225/AP025 Placebo 50mg

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

Intervention: TQA2225/AP025 or TQA2225/AP025 Placebo 50mg

Outcomes

Primary Outcomes

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

Time Frame: 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