NCT06297434

Phase 2a Study to Evaluate Safety and Explore Efficacy of J2H-1702 for NASH

A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IIa Clinical Trial to Evaluate the Safety and Explore the Efficacy of J2H-1702 for Non-alcoholic Steatohepatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: J2H Biotech · Industry
• Sex: All
• Age: 19 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The study aims to evaluate the safety of J2H-1702 compared to the placebo and explore the efficacy of J2H-1702 at Week 12 timepoint after administration compared to baseline in patients with NASH.

Detailed description

Subjects will be randomized to the study group 1 (J2H-1702 A mg), study group 2 (J2H-1702 B mg), study group 3 (J2H-1702 C mg), or control group (placebo of J2H-1702) in a 1:1:1:1 ratio and administered the investigational product (IP) for 12 weeks. After the IP administration, the safety and efficacy will be evaluated at V4, V8 and V12 (end of treatment, EOT).

Conditions

• Non-alcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	J2H-1702	Orally, once daily before meals
DRUG	J2H-1702	Orally, once daily before meals
DRUG	J2H-1702	Orally, once daily before meals
DRUG	Placebo	Orally, once daily before meals

Timeline

• Start date: 2023-02-15
• Primary completion: 2025-06-26
• Completion: 2025-11-05
• First posted: 2024-03-07
• Last updated: 2025-12-17

Locations

1 site across 1 country: South Korea