🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in the USA / NCT07323784
Recruiting Phase 2

A Study of NTX-1472 in Social Anxiety Disorder

NCT07323784 · tracked via the Priya Life Science USA tracker
Sponsor
Newleos Therapeutics, Inc.
Phase
Phase 2
Started
2025-12-09
Last updated
2026-07-09

Condition(s) studied

Social Anxiety Disorder (SAD)

Investigational drug(s) / intervention(s)

NTX-1472Placebo

NTX-1472: Daily (QD) x 8 weeks.

Placebo: Daily (QD) x 8 weeks.

Study summary

The primary goal of this Phase 2 clinical trial is to determine the effects of a novel V1a receptor antagonist (NTX-1472) in adults with Social Anxiety Disorder (SAD). The main questions this trial aims to answer are:

* Is NTX-1472 safe and well tolerated in adults with SAD?
* How effectively does NTX-1472 treat adults with SAD?

Researchers will compare the effects of NTX-1472 with matching placebo (a look-alike capsule that contains no drug).

Participants will:

* Take NTX-1472 or matching placebo every day for 8 weeks
* Visit the clinic 6 times over the course of 14 weeks for checkups and tests

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Key Inclusion Criteria * Has provided written informed consent for the study and is willing to comply with all requirements of the protocol * English speaker * Male or female, ≥18 and ≤65 years of age * Current diagnosis of generalized Social Anxiety Disorder (SAD) as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM 5) and confirmed by the Structured Clinical Interview for DSM-5 (SCID-5-CT). * Clinician-administered Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening * Clinician-rated Hamilton Depression Rating Scale (HDRS 17) (17 items) total score \<16 at Screening * If participant is of childbearing potential, must commit to practicing effective methods of birth control during the study and at least 14 days after the last dose. Key Exclusion Criteria * Current diagnosis of performance-only SAD as defined by the DSM-5 and confirmed by the SCID-5-CT. * Current diagnosis of any of the following psychiatric condition(s) as defined by the DSM-5 (participants with current generalized anxiety disorder may be included): Attention-deficit/hyperactivity disorder, Autism spectrum disorder, Major depressive disorder, Personality disorder, Post-traumatic stress disorder. * Past or current diagnosis of any of the following psychiatric condition(s), as defined by the DSM-5: Bipolar disorder, Feeding and eating disorder (in adulthood), Obsessive-compulsive disorder, Schizophrenia spectrum or other psychotic disorder, Substance use disorder (within 12 months of Screening). * Receiving daily psychotropics within 4 weeks of Screening * Is at risk for suicidal ideation as per C-SSRS * Has moderate or severe hepatic impairment * Has severe renal impairment * Women who are pregnant or women who are currently breastfeeding unless they are willing to stop breastfeeding for the duration of the study.

Primary outcome measure(s)

Trial sites (11)

FacilityCityRegionStatus
SOAR Clinical Study Site Encino California Recruiting
SOAR Clinical Study Site Los Angeles California Recruiting
SOAR Clinical Study Site Oceanside California Recruiting
SOAR Clinical Study Site San Jose California Recruiting
SOAR Clinical Study Site Jacksonville Florida Recruiting
SOAR Clinical Study Site Tampa Florida Recruiting
SOAR Clinical Study Site Boston Massachusetts Recruiting
SOAR Clinical Study Site Las Vegas Nevada Active Not Recruiting
SOAR Clinical Study Site Brooklyn New York Recruiting
SOAR Clinical Study Site Memphis Tennessee Recruiting
SOAR Clinical Study Site Austin Texas Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07323784 on ClinicalTrials.gov ↗ ← All trials in the USA