NCT05407064

A Dose-Finding Study of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

A Phase 2, Multi-center, Randomized, Double-Blind, Parallel-Group, Dose-Finding Study to Assess the Effect of Four Doses of MM120 (LSD D-Tartrate) for the Treatment of Anxiety Symptoms

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Definium Therapeutics US, Inc. · Industry
• Sex: All
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, multi-center, randomized, double-blind, parallel-group, dose-finding study to assess the effect of 4 doses of MM120 (25, 50, 100 or 200 μg freebase-equivalent) for the treatment of anxiety symptoms in subjects diagnosed with generalized anxiety disorder (GAD).

Detailed description

The study will enroll approximately 200 male and female subjects 18 years to \< 75 years of age who meet DSM-5 criteria for GAD and have a minimum HAM-A Total Score of 20. Subjects on contraindicated concomitant medications, supplements or other therapeutics at Screening (Visit 1) will undergo a medication taper prior to advancing to Baseline (Visit 2).

Conditions

• Anxiety Generalized

Interventions

Type	Name	Description
DRUG	MM120	A psychoactive substance that mediates effects mainly through an agonist activity in the serotonin 2A receptor (5-HT2A).
OTHER	Placebo	A substance that is designed to have no therapeutic value.

Timeline

• Start date: 2022-08-24
• Primary completion: 2023-10-06
• Completion: 2023-11-27
• First posted: 2022-06-07
• Last updated: 2026-02-27
• Results posted: 2025-03-20

Locations

22 sites across 1 country: United States

Regulatory

• FDA-regulated drug study