RecruitingPhase 2NCT07323784

A Study of NTX-1472 in Social Anxiety Disorder

A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, and Efficacy of NTX-1472, a V1a Receptor Antagonist, in Adults With Social Anxiety Disorder


Sponsor

Newleos Therapeutics, Inc.

Enrollment

100 participants

Start Date

Dec 9, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new experimental drug called NTX-1472 for adults with generalized social anxiety disorder (SAD) — a condition where fear of social situations significantly disrupts daily life. Researchers want to see if NTX-1472 is safe and can reduce social anxiety. **You may be eligible if...** - You are 18–65 years old and an English speaker - You have been diagnosed with generalized social anxiety disorder by a clinical interview - Your social anxiety score is 70 or above on a standard rating scale (LSAS) - You do not have severe depression currently - You are not taking daily psychiatric medications **You may NOT be eligible if...** - Your social anxiety is limited to performance situations only (like public speaking) - You have a current diagnosis of ADHD, autism, major depression, PTSD, or a personality disorder - You have a history of bipolar disorder, OCD, an eating disorder, psychosis, or substance use disorder in the past year - You are at risk for suicide - You have significant liver or kidney problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGNTX-1472

Daily (QD) x 8 weeks.

DRUGPlacebo

Daily (QD) x 8 weeks.


Locations(11)

SOAR Clinical Study Site

Pheonix, Arizona, United States

SOAR Clinical Study Site

Encino, California, United States

SOAR Clinical Study Site

Los Angeles, California, United States

SOAR Clinical Study Site

Oceanside, California, United States

SOAR Clinical Study Site

San Jose, California, United States

SOAR Clinical Study Site

Jacksonville, Florida, United States

SOAR Clinical Study Site

Tampa, Florida, United States

SOAR Clinical Study Site

Boston, Massachusetts, United States

SOAR Clinical Study Site

Brooklyn, New York, United States

SOAR Clinical Study Site

Memphis, Tennessee, United States

SOAR Clinical Study Site

Austin, Texas, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07323784


Related Trials