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Completed

NCT Number: NCT05397379

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

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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Key information

Conditions

Non-alcoholic Steatohepatitis Digestive System Diseases Fatty Liver Liver Diseases Non-alcoholic Fatty Liver Disease

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's Hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

HEC96719

Drug

Oral tablets

Placebo

Drug

Comparator

Primary outcomes

  1. Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Time frame: 12 weeks

Secondary outcomes

  1. 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

    Time frame: Baseline and Week 12

  2. Plasma concentration of HEC96719 - AUC

    Time frame: 4 weeks

    Area under the curve

  3. Plasma concentration of HEC96719 - Cmax

    Time frame: 4 weeks

    Maximum observed concentration

  4. Plasma concentration of HEC96719 - Tmax

    Time frame: 4 weeks

    Time to reach maximum measured plasma concentration

  5. Plasma concentration of HEC96719 - t1/2

    Time frame: 4 weeks

    Determination of half-life

Sponsors and collaborators

Lead sponsor

Sunshine Lake Pharma Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 31, 2022
Registry last updated
Feb 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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