NCT06708260

A Phase 2 Study to Evaluate the Efficacy and Safety of ENN0403 in Subjects with DME

A Phase 2, Multicenter, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Two Doses of ENN0403 in Subjects with Diabetic Macular Edema (DME)

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: EnnovaBio · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, parallel study to evaluate the efficacy and safety of two doses of ENN0403 in subjects with diabetic macular edema (DME). Approximately 60 subjects will be randomized to receive ENN0403 capsule orally once a day at the low dose or high dose with a 1:1 ratio. The study period consisted of up to 2 weeks of screening, 12 weeks of treatment and 2 weeks of follow-up, and the entire trial period was up to 16 weeks.

Conditions

• Diabetic Macular Edema (DME)

Interventions

Type	Name	Description
DRUG	ENN0403, low dose	ENN0403 capsules will be orally administered once a day for 12 weeks.
DRUG	ENN0403, high dose	ENN0403 capsules will be orally administered once a day for 12 weeks.

Timeline

• Start date: 2024-12-12
• Primary completion: 2025-12-01
• Completion: 2026-02-01
• First posted: 2024-11-27
• Last updated: 2025-02-21

Locations

1 site across 1 country: China