NCT05397379CompletedPhase 2
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Safety, Tolerability, Efficacy, and Pharmacokinetics of Orally Administered HEC96719 Tablets in Adult Patients With Presumed Non-Cirrhotic Non-Alcoholic Steatohepatitis
Sunshine Lake Pharma Co., Ltd.9 sites in 1 country68 target enrollmentStarted: November 15, 2021Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 68
- Locations
- 9
- Primary Endpoint
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Study Overview
Brief Summary
This is a Phase 2, randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, efficacy, and pharmacokinetics of HEC96719 in non-cirrhotic NASH patients.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •An informed consent document must be signed and dated by the subject
- •Male or female, 18 to 65 years of age
- •Body mass index (BMI)≥18.0 and≤35.0 kg/m2, and Weight≥40 kg;
- •Presumed NASH based on clinical characteristics or prior liver biopsy
- •MRI PDFF liver fat content ≥ 10 %
Exclusion Criteria
- •previous diagnosis of other forms of chronic liver disease
- •Laboratory Screening Results:
- •AST > 5 x ULN
- •ALP > 3 x ULN
- •Total bilirubin > 1.5 x ULN
- •Albumin < 3.2 g/dL
- •INR > 1.3
- •Platelet count < 100,000 /mm3
- •creatinine clearance <60 ml/min (based on Cockroft Gault method)
- •previous exposure to OCA
- •uncontrolled diabetes mellitus
- •presence of cirrhosis
- •patients with contraindications to MRI imaging
Arms & Interventions
HEC96719 0.25 mg bid
Experimental
Oral dose twice daily for 12 weeks
Intervention: HEC96719 (Drug)
HEC96719 0.25 mg
Experimental
Oral dose once daily for 12 weeks
Intervention: HEC96719 (Drug)
HEC96719 0.35 mg
Experimental
Oral dose once daily for 12 weeks
Intervention: HEC96719 (Drug)
HEC96719 0.5 mg
Experimental
Oral dose once daily for 12 weeks
Intervention: HEC96719 (Drug)
Placebo
Placebo Comparator
Oral dose once or twice daily for 12 weeks
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 12 weeks
Secondary Outcomes
- Mean Change From Baseline in Percentage of Fat in the Liver as Assessed by Magnetic Resonance Imaging - Proton Density Fat Fraction (MRI-PDFF) at Week 12(Baseline and Week 12)
- Plasma concentration of HEC96719 - t1/2(4 weeks)
- Plasma concentration of HEC96719 - Tmax(4 weeks)
- Plasma concentration of HEC96719 - AUC(4 weeks)
- Plasma concentration of HEC96719 - Cmax(4 weeks)
Investigators
Study Sites (9)
Loading locations...
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