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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2023-09-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-Alcoholic Steatohepatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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HEC96719 0.25 mg

Oral dose once daily for 12 weeks

Group Type EXPERIMENTAL

HEC96719

Intervention Type DRUG

Oral tablets

HEC96719 0.35 mg

Oral dose once daily for 12 weeks

Group Type EXPERIMENTAL

HEC96719

Intervention Type DRUG

Oral tablets

HEC96719 0.5 mg

Oral dose once daily for 12 weeks

Group Type EXPERIMENTAL

HEC96719

Intervention Type DRUG

Oral tablets

HEC96719 0.25 mg bid

Oral dose twice daily for 12 weeks

Group Type EXPERIMENTAL

HEC96719

Intervention Type DRUG

Oral tablets

Placebo

Oral dose once or twice daily for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Comparator

Interventions

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HEC96719

Oral tablets

Intervention Type DRUG

Placebo

Comparator

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No