NCT06236880

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

A Phase 2a Study to Evaluate the Safety and Tolerability of Two Repeated Doses of GM-2505 at a 2-Week Interval in Patients With Major Depressive Disorder.

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Gilgamesh Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Major Depressive Disorder

Interventions

Type	Name	Description
DRUG	GM-2505	IV

Timeline

• Start date: 2024-01-31
• Primary completion: 2026-10-01
• Completion: 2026-10-01
• First posted: 2024-02-01
• Last updated: 2026-02-09

Locations

1 site across 1 country: United Kingdom