A Dose-Response Safety Study of ENX-102 in Patients With GAD

Phase 2

Recruiting

• Conditions: General Anxiety Disorder
• Interventions: Drug: Placebo; Drug: ENX-102

• Registration Number: NCT06653296
• Lead Sponsor: Engrail Therapeutics INC

Brief Summary

This is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ENX-102 and determine a dose-response for the effects of ENX-102 in patients with GAD

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-10-20
• Study First Submitted QC: 2024-10-20
• Study First Posted: 2024-10-22
• Study Start: 2024-12-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-09
• Last Update Posted: 2025-02-12
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

• Male or female, inclusive of any gender identity, aged 18 to 65 years, inclusive
• Diagnosed with GAD according to the DSM-V, confirmed by MINI
• Experiencing clinically significant generalized anxiety as measured by HAM-A score ≥18 and at least moderately severe core symptoms of anxious mood and tension as measured by HAM-A Items 1 and 2, respectively, with scores each ≥2

Key

Exclusion Criteria

• Clinically predominant psychiatric diagnosis other than GAD per the MINI
• Any past/lifetime or current diagnosis of a neurocognitive disorder or psychotic disorder, or current posttraumatic stress disorder, obsessive compulsive disorder, or bipolar disorder
• Ingested prohibited medication within 5 half-lives prior to Day 1
• Current or recent moderate or severe substance use disorder as assessed by the MINI
• Unwilling or unable to abstain from alcohol or other recreational psychoactive substances such as marijuana during participation in the trial
• Has significant progressive disorders or unstable medical conditions
• Is unable to comply with the requirements of the study or, in the opinion of the Investigator, is unsuitable for the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
ENX-102 mid-dose	ENX-102	ENX-102
ENX-102 low-dose	ENX-102	ENX-102
ENX-102 high-dose	ENX-102	ENX-102

Primary Outcome Measures

Name	Time	Method
Safety and tolerability	4 weeks	• Incidence and severity of treatment-emergent AEs (TEAEs)

Trial Locations

Locations (1)

MAC Clinical Research; 🇬🇧 Manchester, United Kingdom