A Safety, Tolerability, Efficacy, and Pharmacokinetics Study of HEC96719 in Subjects With Non-Cirrhotic Non-Alcoholic Steatohepatitis
NCT05397379 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 68
Last updated 2024-02-21
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.
Conditions
- Non-Alcoholic Steatohepatitis
Interventions
- DRUG
-
HEC96719
Oral tablets
- DRUG
-
Comparator
Sponsors & Collaborators
-
Sunshine Lake Pharma Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Jinlin Hou, Doctor · Nanfang Hospital, Southern Medical University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-11-15
- Primary Completion
- 2023-09-05
- Completion
- 2023-09-05
Countries
- China
Study Locations
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