NCT07309380

Phase III Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D

Double-blinded Placebo-controlled Multi-center Phase III Clinical Trial of Hepalatide in Patients With Chronic Hepatitis D

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Shanghai HEP Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study adopts a multicenter, randomized, double-blind, placebo-parallel controlled design to evaluate the efficacy and safety of L47 in the treatment of chronic hepatitis D. A total of 150 subjects are planned to be enrolled. After passing the screening, they will be randomly assigned to the L47 group or the placebo group at a ratio of 2:1, with liver cirrhosis and subjects' regional distribution as stratification factors. The two groups will receive hepratide (2.1 mg/day) or placebo, respectively. Upon completion of the 48-week double-blind treatment phase, all subjects in each group can enter the open-label treatment follow-up phase, where they may voluntarily choose to receive L47 (2.1 mg/day) treatment or undergo follow-up observation only, until week 144. Subjects who discontinue treatment prematurely during the trial may also enter the open-label treatment follow-up phase. An interim analysis will be conducted after the subjects complete 24 weeks of trial treatment, with the comprehensive response rate at week 24 as the primary endpoint. The analysis will be performed by an independent statistical team. And the interim analysis results will be reviewed by the Independent Data Monitoring Committee (IDMC) . All subjects will complete the 48-week double-blind clinical trial. Throughout the entire study period, the safety of subjects will be closely monitored and evaluated, including the monitoring of adverse events (AEs) and other safety indicators.

Conditions

• Hepatitis D, Chronic

Interventions

Type	Name	Description
DRUG	Hepalatide 2.1mg	Continuous treatment with hepalatide 2.1mg sc, qd, for 48 weeks
DRUG	Placebo of Hepalatide	Continuous treatment with placebo of hepalatide for 48 weeks

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-06-01
• Completion: 2027-08-01
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: China