NCT06693609

Exploratory Safety and Efficacy of EMP-01 in Social Anxiety Disorder

A Phase 2a, Exploratory, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability, and Efficacy of EMP-01 in Adult Participants With Social Anxiety Disorder

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: atai Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This Phase 2 study (protocol number EMP-01-201) will determine the safety and tolerability of a short-term treatment with an oral dosage form of EMP-01 in adult participants with social anxiety disorder (SAD) and will assess exploratory efficacy of repeated doses of EMP-01 versus placebo.

Detailed description

This Phase 2, exploratory, multi-center, double-blind, randomized, placebo-controlled trial will enroll approximately 60 adult participants with SAD, randomized 1:1 to receive a total of 2 double-blind administrations of EMP-01 or placebo with a 4-week interval between each administration during the placebo-controlled treatment period. All participants will have their symptoms monitored for 6 weeks until the conclusion of the study. While the primary objective of the study is to assess the safety and tolerability of EMP-01 in participants with SAD, the secondary objective is to estimate any improvement in social anxiety symptoms of participants compared to placebo.

Conditions

• Social Anxiety Disorder

Interventions

Type	Name	Description
DRUG	EMP-01	EMP-01 capsules
DRUG	EMP-01 Placebo	EMP-01 placebo capsules

Timeline

• Start date: 2025-04-15
• Primary completion: 2026-02-12
• Completion: 2026-02-12
• First posted: 2024-11-18
• Last updated: 2026-02-17

Locations

7 sites across 1 country: United Kingdom