A Study of NTX-1472 in Social Anxiety Disorder
SOAR
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
1 other identifier
interventional
100
1 country
11
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Dec 2025
Shorter than P25 for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 9, 2025
CompletedFirst Submitted
Initial submission to the registry
January 6, 2026
CompletedFirst Posted
Study publicly available on registry
January 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
January 1, 2027
January 21, 2026
January 1, 2026
1.1 years
January 6, 2026
January 16, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Incidence and severity of treatment-emergent adverse events (TEAEs)
Baseline to Week 8
Secondary Outcomes (11)
Change in the clinician-administered Liebowitz Social Anxiety Scale (LSAS) total score
Baseline to Week 8
Change in LSAS Fear/Anxiety and Avoidance subscale score
Baseline to Week 8
Number and percentage of participants who are responders (≥50% improvement from Baseline [Day 1]) based on the LSAS total score
Baseline to Week 8
Number and percentage of participants who are remitters based on an LSAS total score of <30
Baseline to Week 8
Change in Hamilton Anxiety Rating Scale (HAM-A) total score
Baseline to Week 8
- +6 more secondary outcomes
Study Arms (2)
NTX-1472
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
SOAR Clinical Study Site
Pheonix, Arizona, 85012, United States
SOAR Clinical Study Site
Encino, California, 91316, United States
SOAR Clinical Study Site
Los Angeles, California, 90025, United States
SOAR Clinical Study Site
Oceanside, California, 92056, United States
SOAR Clinical Study Site
San Jose, California, 95124, United States
SOAR Clinical Study Site
Jacksonville, Florida, 32256, United States
SOAR Clinical Study Site
Tampa, Florida, 33615, United States
SOAR Clinical Study Site
Boston, Massachusetts, 02131, United States
SOAR Clinical Study Site
Brooklyn, New York, 11229, United States
SOAR Clinical Study Site
Memphis, Tennessee, 38119, United States
SOAR Clinical Study Site
Austin, Texas, 78737, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 6, 2026
First Posted
January 7, 2026
Study Start
December 9, 2025
Primary Completion (Estimated)
January 1, 2027
Study Completion (Estimated)
January 1, 2027
Last Updated
January 21, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will not share