NCT05397379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 15, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 31, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2023

Completed
Last Updated

February 21, 2024

Status Verified

May 1, 2022

Enrollment Period

1.8 years

First QC Date

May 25, 2022

Last Update Submit

February 20, 2024

Conditions

Non-Alcoholic Steatohepatitis

Outcome Measures

Primary Outcomes (1)

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

    12 weeks

Secondary Outcomes (5)

  • 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

  • Plasma concentration of HEC96719 - Cmax

    4 weeks

  • Plasma concentration of HEC96719 - Tmax

    4 weeks

  • Plasma concentration of HEC96719 - t1/2

    4 weeks

Study Arms (5)

HEC96719 0.25 mg

EXPERIMENTAL

Oral dose once daily for 12 weeks

Drug: HEC96719

HEC96719 0.35 mg

EXPERIMENTAL

Oral dose once daily for 12 weeks

Drug: HEC96719

HEC96719 0.5 mg

EXPERIMENTAL

Oral dose once daily for 12 weeks

Drug: HEC96719

HEC96719 0.25 mg bid

EXPERIMENTAL

Oral dose twice daily for 12 weeks

Drug: HEC96719

Placebo

PLACEBO COMPARATOR

Oral dose once or twice daily for 12 weeks

Drug: Placebo

Interventions

HEC96719DRUG

Oral tablets

HEC96719 0.25 mgHEC96719 0.25 mg bidHEC96719 0.35 mgHEC96719 0.5 mg
PlaceboDRUG

Comparator

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 %

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Location

NanFang Hospital of Southern Medical University

Guangzhou, Guangdong, 510515, China

Location

Affiliated Hospitol of Guangdong Medical University

Guangzhou, Guangdong, China

Location

Union Hospital, TongJi Medical College, HuaZhong University of Science and Technology

Wuhan, Hubei, China

Location

Hunan Provincial People's Hospital

Changsha, Hunan, China

Location

The First Hospital of Jilin University

Changchun, Jilin, China

Location

The First Affiliated Hospitol of Xi'an Jiaotong University

Xi’an, Shanxi, China

Location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

The First Affiliated Hospitol of Wenzhou Medical University

Wenzhou, Zhejiang, China

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System Diseases

Study Officials

  • Jinlin Hou, Doctor

    Nanfang Hospital, Southern Medical University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2022

First Posted

May 31, 2022

Study Start

November 15, 2021

Primary Completion

September 5, 2023

Study Completion

September 5, 2023

Last Updated

February 21, 2024

Record last verified: 2022-05

Locations

CN(9)