A Dose-Response Safety Study of ENX-102 in Patients With GAD | NCT06653296

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

NCT06653296

Sponsor

Engrail Therapeutics INC

Status

Completed

Last Update Posted

Sep 17, 2025Actual

Enrollment

38Actual

Phase

Phase 2

Conditions

General Anxiety Disorder

Interventions

ENX-102
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 9, 2024Actual

Primary Completion Date

Jun 23, 2025Actual

Completion Date

Jun 23, 2025Actual

First Submitted Date

Oct 20, 2024

First Submission Date that Met QC Criteria

Oct 20, 2024

First Posted Date

Oct 22, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 16, 2025

Last Update Posted Date

Sep 17, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

38Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Placebo	Placebo Comparator	Placebo	Drug: Placebo
ENX-102 low-dose	Experimental	ENX-102	Drug: ENX-102
ENX-102 mid-dose	Experimental	ENX-102	Drug: ENX-102
ENX-102 high-dose	Experimental	ENX-102	Drug: ENX-102

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ENX-102	Drug	Four weeks of ENX-102 (0.5, 1, or 3 mg) in capsule form followed by 2 weeks of tapered dose, taken orally once daily in the evening for a 6-week total treatment period

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety and tolerability	• Incidence and severity of treatment-emergent AEs (TEAEs)	4 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Key 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Kimberly Vanover, PhD	Engrail Therapeutics INC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
MAC Clinical Research		Liverpool	UK		United Kingdom
MAC Clinical Research

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D000098647	Generalized Anxiety Disorder
D001008	Anxiety Disorders