A Study of NTX-1472 in Social Anxiety Disorder (SOAR)

January 16, 2026 updated by: Newleos Therapeutics, Inc.

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Pheonix, Arizona, United States, 85012
        • Recruiting
        • SOAR Clinical Study Site
        • Contact:
    • California
      • Encino, California, United States, 91316
        • Recruiting
        • SOAR Clinical Study Site
        • Contact:
      • Los Angeles, California, United States, 90025
        • Recruiting
        • SOAR Clinical Study Site
        • Contact:
      • Oceanside, California, United States, 92056
        • Recruiting
        • SOAR Clinical Study Site
        • Contact:
      • San Jose, California, United States, 95124
        • Recruiting
        • SOAR Clinical Study Site
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32256
        • Recruiting
        • SOAR Clinical Study Site
        • Contact:
      • Tampa, Florida, United States, 33615
        • Recruiting
        • SOAR Clinical Study Site
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Recruiting
        • SOAR Clinical Study Site
        • Contact:
    • New York
      • Brooklyn, New York, United States, 11229
        • Recruiting
        • SOAR Clinical Study Site
        • Contact:
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • SOAR Clinical Study Site
        • Contact:
    • Texas
      • Austin, Texas, United States, 78737
        • Recruiting
        • SOAR Clinical Study Site
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Daily (QD) x 8 weeks.
Experimental: NTX-1472
Drug: NTX-1472
Daily (QD) x 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time Frame: Baseline to Week 8
Baseline to Week 8

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the clinician-administered Liebowitz Social Anxiety Scale (LSAS) total score
Time Frame: Baseline to Week 8
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.
Baseline to Week 8
Change in LSAS Fear/Anxiety and Avoidance subscale score
Time Frame: Baseline to Week 8
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.
Baseline to Week 8
Number and percentage of participants who are responders (≥50% improvement from Baseline [Day 1]) based on the LSAS total score
Time Frame: Baseline to Week 8
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.
Baseline to Week 8
Number and percentage of participants who are remitters based on an LSAS total score of <30
Time Frame: Baseline to Week 8
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.
Baseline to Week 8
Change in Hamilton Anxiety Rating Scale (HAM-A) total score
Time Frame: Baseline to Week 8
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale that is designed to rate severity of anxiety. The total score ranges from 0 to 56. Higher scores indicate greater severity of anxiety.
Baseline to Week 8
Clinical Global Impression - Severity (CGI-S) score
Time Frame: Baseline to Week 8
The Clinical Global Impression - Severity (CGI-S) score is rated on a 7-point scale, using a range of responses from 1 (normal, not at all ill) through to 7 (among the most extremely ill patients).
Baseline to Week 8
Patient Global Impression - Severity (PGI-S) score
Time Frame: Baseline to Week 8
The Patient Global Impression - Severity (CGI-S) score is rated on a 7-point scale, using a range of responses from 1 (not present) through to 7 (extremely severe).
Baseline to Week 8
Change in Depression Anxiety Stress Scale - 21 items (DASS-21, Stress subscale only)
Time Frame: Baseline to Week 8
The Depression Anxiety Stress Scale - 21 items (DASS-21), Stress subscale ranges from 0 to 21, with higher scores indicating greater stress severity.
Baseline to Week 8
Change in University of California, Los Angeles Loneliness Scale 10-items (UCLA LS 10) score
Time Frame: Baseline to Week 8
The University of California, Los Angeles Loneliness Scale 10-items (UCLA LS 10) score ranges from 10 to 40, with higher scores indicating greater perceived loneliness.
Baseline to Week 8
Change in Pittsburgh Sleep Quality Index (PSQI) global score
Time Frame: Baseline to Week 8
The Pittsburgh Sleep Quality Index (PSQI) global score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Baseline to Week 8
Change in State-Trait Anxiety Inventory (STAI) state
Time Frame: Baseline to Week 8
The State-Trait Anxiety Inventory (STAI) state score ranges from 20 to 80, with higher scores indicating greater anxiety in the moment.
Baseline to Week 8

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Newleos Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 9, 2025

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

January 6, 2026

First Submitted That Met QC Criteria

January 6, 2026

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 21, 2026

Last Update Submitted That Met QC Criteria

January 16, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTX-1472-201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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