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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 9, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 6, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 6, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 7, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 21, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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