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

Non-Alcoholic Steatohepatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05397379
• Other study ID #: HEC96719-NASH-201
• Status: Completed
• Phase: Phase 2
• Start date: November 15, 2021
• Est. completion date: September 5, 2023

Study information

• Verified date: May 2022
• Source: Sunshine Lake Pharma Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: September 5, 2023
• Est. primary completion date: September 5, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Non-alcoholic Fatty Liver Disease
• Non-Alcoholic Steatohepatitis

Intervention

Drug:
• HEC96719
Oral tablets
• Placebo
Comparator

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing
China	The First Hospital of Jilin University	Changchun	Jilin
China	Hunan Provincial People's Hospital	Changsha	Hunan
China	Affiliated Hospitol of Guangdong Medical University	Guangzhou	Guangdong
China	NanFang Hospital of Southern Medical University	Guangzhou	Guangdong
China	The First Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	The First Affiliated Hospitol of Wenzhou Medical University	Wenzhou	Zhejiang
China	Union Hospital, TongJi Medical College, HuaZhong University of Science and Technology	Wuhan	Hubei
China	The First Affiliated Hospitol of Xi'an Jiaotong University	Xi'an	Shanxi

Sponsors (1)

Lead Sponsor	Collaborator
Sunshine Lake Pharma Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)		12 weeks
Secondary	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
Secondary	Plasma concentration of HEC96719 - AUC	Area under the curve	4 weeks
Secondary	Plasma concentration of HEC96719 - Cmax	Maximum observed concentration	4 weeks
Secondary	Plasma concentration of HEC96719 - Tmax	Time to reach maximum measured plasma concentration	4 weeks
Secondary	Plasma concentration of HEC96719 - t1/2	Determination of half-life	4 weeks