Home › Trials › NCT05749055

Treatment of Generalized Anxiety Disorder with ENX-102

The ENCALM Trial: a Randomized, Double-blind, Placebo-controlled Monotherapy Trial to Evaluate the Efficacy and Safety of ENX-102 in Patients with Generalized Anxiety Disorder

PHASE2 · Engrail Therapeutics INC · NCT05749055

This study is testing if a new medication called ENX-102 can help adults with generalized anxiety disorder feel less anxious compared to a placebo.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment280 (estimated)
Ages18 Years to 65 Years
SexAll
SponsorEngrail Therapeutics INC (industry)
Locations32 sites (Phoenix, Arizona and 31 other locations)
Trial IDNCT05749055 on ClinicalTrials.gov

What this trial studies

The ENCALM trial evaluates the efficacy and safety of ENX-102 as a monotherapy for patients diagnosed with generalized anxiety disorder (GAD). Participants will be randomly assigned to receive either ENX-102 or a placebo, with their anxiety levels assessed using standardized scales. The study aims to determine if ENX-102 can significantly reduce anxiety symptoms compared to placebo. This Phase 2 trial will involve adult participants aged 18 to 65 who meet specific diagnostic criteria for GAD.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with generalized anxiety disorder who experience significant anxiety symptoms.

Not a fit: Patients with predominant psychiatric diagnoses other than GAD or those with certain comorbid conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from generalized anxiety disorder.

How similar studies have performed: Other studies have explored treatments for GAD, but the specific approach with ENX-102 is novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Key Inclusion Criteria:

* Male or female at birth, inclusive of any gender identity, aged 18 to 65 years, inclusive, at Screening
* Diagnosed with GAD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5), confirmed by a Mini-International Neuropsychiatric Interview (MINI) version 7.0.2
* Experiencing clinically significant generalized anxiety in need of treatment as measured by Hamilton Anxiety Rating Scale (HAM-A) Screening and Day 1 scores ≥22 and at least moderately severe score symptoms of anxious mood and tension as measured by HAM-A items 1 and 2, respectively, with score each ≥2 at Screening and Day 1

Key Exclusion Criteria:

* Clinically predominant psychiatric diagnosis other than GAD as confirmed by the MINI
* Any past/lifetime/current diagnosis of a neurocognitive disorder, or psychotic disorder, or any current diagnosis of posttraumatic stress disorder, obsessive compulsive disorder or bipolar disorder confirmed by independent adjudication
* Reports moderately severe to severe symptoms of depression
* Ingested psychotropic medication within 5 half-lives or 21 days (whichever is longer) prior to Day 1, including THC and CBD, and unwillingness to refrain from their use for the entire duration of the trial
* Recent suicidal ideation or behavior
* Current or recent moderate to severe substance use disorder as assessed by the MINI
* Clinically significant abnormal findings in safety assessments
* Has significant progressive disorders or unstable medical conditions
* Unable to comply with the requirements of the study or, in the opinion of the Investigator or Sponsor, is unsuitable for the study

Where this trial is running

Phoenix, Arizona and 31 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Generalized Anxiety Disorder

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.