A Clinical Trial of BGT-002 Tablets in Subjects With Nonalcoholic Steatohepatitis
NCT Number: NCT06491576
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: PHASE1|PHASE2
Conditions: NASH
Interventions: DRUG: BGT-002|DRUG: Placebo
Sponsor: Burgeon Therapeutics Co., Ltd.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 48
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2023-03-21
Completion Date: 2024-03-04
Locations: The First Bethune Hospital of Jilin University, Changchun, Jilin, 130031, China

Summary:
This study is a single-center, randomized, double-blind, multiple ascending doses (MAD), placebo-controlled phase Ib/IIa clinical trial of BGT-002 Tablets in subjects with NASH to evaluate the safety, tolerability, pharmacokinetics (PK) and early pharmacodynamics (PD) of BGT-002 Tablets.

Primary Outcome Measures: Number of participants with adverse events, From Day 1 to Day 56|C-QTc(Concentration-QTc), To investigate the effect of BGT-002 on QT/QTc interval in subjects, Day1、Day28
Secondary Outcome Measures: Cmax(Peak Concentration), The peak concentration of BGT-002 tablets was assessed after oral administration of BGT-002, Day1|Tmax(Time of maximum observed concentration), Evaluate the time required for the drug to reach its maximum concentration after oral administration of BGT-002, Day1|AUC(0-24h)(Area Under Curve), The area under the curve was assessed 0 to 24 hours after oral administration of BGT-002, Day1|Cmax,ss, The peak concentration at stable state was assessed after oral administration of BGT-002, Day28|Tmax,ss, The peak time at stable state was assessed after oral administration of BGT-002, Day28|AUCss, The area under the curve at stable state after the subject's oral administration of BGT-002 was assessed, Day28|CLss/F(Steady-State Clearance/bioavailability,F), The clearance rate at stalbe state was assessed after oral administration of BGT-002, Day28|Cmin,ss, Assess valley concentrations at stable state after oral administration of BGT-002, Day28|Rac(Accumulation Ratio), Assess the drug accumulation index after oral administration of BGT-002, Day28|MRI-PDFF(Magnetic resonance imaging-derived proton density fat fraction), Assess the changes of magnetic resonance imaging derived proton density fat fraction after oral administration of BGT-002, Day1 (for subjects with results within 7 days pre-dose, examination may be omitted on Day1), Day29/early withdrawal (+5 days), and Day56 (± 5 days)|CAP(controlled attenuation parameter), Assess the changes of controlled attenuation parameter based on ultrasound after oral administration of BGT-002, Day1 (for subjects with results within 7 days pre-dose, examination may be omitted on Day1), Day29/early withdrawal (+5 days), and Day56 (± 5 days)y29、Day56|LSM(Liver Stiffness Measuremen), Assess the changes of liver stiffness measurement after oral administration of BGT-002, Day1 (for subjects with results within 7 days pre-dose, examination may be omitted on Day1), Day29/early withdrawal (+5 days), and Day56 (± 5 days)|BMI(Body Mass Index), Changes of Body Mass Index were assessed after oral administration of BGT-002, Day1, Day29/early withdrawal, and Day56 (± 5 days)|ALT(Alanine Aminotransferase), Changes of Alanine Aminotransferase were assessed after oral administration of BGT-002, Day1, Day29/early withdrawal, and Day56 (± 5 days)|ASTc(Aspartate Transaminase), Changes of Aspartate Transaminase were assessed after oral administration of BGT-002, Day1, Day29/early withdrawal, and Day56 (± 5 days)|TG(Triglyceride), Changes of Triglyceride were assessed after oral administration of BGT-002, Day1, Day29/early withdrawal, and Day56 (± 5 days)|LDL-C(Low-Density Lipoprotein Cholesterol), Changes of Low-Density Lipoprotein Cholesterol were assessed after oral administration of BGT-002, Day1, Day29/early withdrawal, and Day56 (± 5 days)|TC(total cholesterol), Changes of serum total cholesterol were assessed after oral administration of BGT-002, Day1, Day29/early withdrawal, and Day56 (± 5 days)