drugset / Trial / NCT06236880

A Phase 2a Study to Evaluate the Safety and Tolerability of GM-2505 in Patients With MDD

NCT06236880 ↗

Phase 2 Recruiting 124 enrolled Gilgamesh Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

Summary

This is a three-part Phase 2a study. The aim of Part A is to assess the safety and tolerability and preliminary antidepressant efficacy in patients with MDD who are not currently on an antidepressant therapy. The aim of Part B is to assess the antidepressant efficacy, safety and tolerability in patients with MDD who are partial responders while on a current and adequate single SSRI or SNRI treatment. Part C aims to replicate the monotherapy findings of Part A, but with a lower control group dose.

Timeline

Start
2024-01-31
Primary completion
2026-10
Completion
2026-10

Drugs

EvaluationDrugModalityDoseRoute
Subject GM-2505 Unknown — —