A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis

Sunshine Lake Pharma

Status and phase: Completed; Phase 2

Conditions: Non-Alcoholic Steatohepatitis

Treatments: Drug: HEC96719; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05397379

HEC96719-NASH-201

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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68 participants in 5 patient groups, including a placebo group

HEC96719 0.25 mg

Experimental group

Description:

Oral dose once daily for 12 weeks

Treatment:

Drug: HEC96719

HEC96719 0.35 mg

Experimental group

Description:

Oral dose once daily for 12 weeks

Treatment:

Drug: HEC96719

HEC96719 0.5 mg

Experimental group

Description:

Oral dose once daily for 12 weeks

Treatment:

Drug: HEC96719

HEC96719 0.25 mg bid

Experimental group

Description:

Oral dose twice daily for 12 weeks

Treatment:

Drug: HEC96719

Placebo

Placebo Comparator group

Description:

Oral dose once or twice daily for 12 weeks

Treatment:

Drug: Placebo