Clinical trial NCT05397379: A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non-Alcoholic Steatohepatitis
Lead sponsor: Sunshine Lake Pharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-05-31
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 12 weeks
Secondary outcomes:
measure: 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
timeFrame: Baseline and Week 12
measure: Plasma concentration of HEC96719 - AUC
timeFrame: 4 weeks
measure: Plasma concentration of HEC96719 - Cmax
timeFrame: 4 weeks
measure: Plasma concentration of HEC96719 - Tmax
timeFrame: 4 weeks
measure: Plasma concentration of HEC96719 - t1/2
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University People's Hospital
state: Beijing
city: Guangzhou
country: China
facility: NanFang Hospital of Southern Medical University
state: Guangdong
city: Guangzhou
country: China
facility: Affiliated Hospitol of Guangdong Medical University
state: Guangdong
city: Wuhan
country: China
facility: Union Hospital, TongJi Medical College, HuaZhong University of Science and Technology
state: Hubei
city: Changsha
country: China
facility: Hunan Provincial People's Hospital
state: Hunan
city: Changchun
country: China
facility: The First Hospital of Jilin University
state: Jilin
city: Xi'an
country: China
facility: The First Affiliated Hospitol of Xi'an Jiaotong University
state: Shanxi
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Wenzhou
country: China
facility: The First Affiliated Hospitol of Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Jinlin Hou, Doctor
role: STUDY_CHAIR
References: