drugset / Trial / NCT06708260

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

NCT06708260 ↗

Phase 2 Recruiting 60 enrolled EnnovaBio
RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2024-12-12
Primary completion
2025-12
Completion
2026-02

Drugs

EvaluationDrugModalityDoseRoute
Subject ENN0403 Unknown — Oral