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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05397379

Enrollment

Registered

2022-05-31

Start date

2021-11-15

Completion date

2023-09-05

Last updated

2024-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-Alcoholic Steatohepatitis

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.

Interventions

DRUGHEC96719

Oral tablets

DRUGPlacebo

Comparator

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)	12 weeks

Secondary

Measure	Time frame	Description
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 - AUC	4 weeks	Area under the curve
Plasma concentration of HEC96719 - Cmax	4 weeks	Maximum observed concentration
Plasma concentration of HEC96719 - Tmax	4 weeks	Time to reach maximum measured plasma concentration
Plasma concentration of HEC96719 - t1/2	4 weeks	Determination of half-life

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026