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A Study of NTX-1472 in Social Anxiety Disorder
Led by Newleos Therapeutics, Inc. · Updated on 2026-01-21
100
Participants Needed
11
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
A Study of NTX-1472 in Social Anxiety Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent and willing to follow study rules
- Speaks English
- Male or female aged 18 to 65 years
- Diagnosed with generalized Social Anxiety Disorder (SAD) per DSM-5 and confirmed by structured interview
- Liebowitz Social Anxiety Score (LSAS) total score of 70 or higher at screening
- Hamilton Depression Rating Scale (HDRS 17) total score below 16 at screening
- If able to have children, agrees to use effective birth control during the study and for 14 days after last dose
You will not qualify if you...
- Diagnosed with performance-only Social Anxiety Disorder
- Current diagnosis of ADHD, autism spectrum disorder, major depressive disorder, personality disorder, or post-traumatic stress disorder (except generalized anxiety disorder allowed)
- Past or current diagnosis of bipolar disorder, eating disorder in adulthood, obsessive-compulsive disorder, schizophrenia spectrum or other psychotic disorder, or substance use disorder within 12 months
- Taking daily psychotropic medications within 4 weeks before screening
- At risk for suicidal thoughts
- Moderate or severe liver impairment
- Severe kidney impairment
- Pregnant or breastfeeding women who will not stop breastfeeding during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 11 locations
1
SOAR Clinical Study Site
Pheonix, Arizona, United States, 85012
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2
SOAR Clinical Study Site
Encino, California, United States, 91316
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3
SOAR Clinical Study Site
Los Angeles, California, United States, 90025
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4
SOAR Clinical Study Site
Oceanside, California, United States, 92056
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5
SOAR Clinical Study Site
San Jose, California, United States, 95124
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6
SOAR Clinical Study Site
Jacksonville, Florida, United States, 32256
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7
SOAR Clinical Study Site
Tampa, Florida, United States, 33615
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8
SOAR Clinical Study Site
Boston, Massachusetts, United States, 02131
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9
SOAR Clinical Study Site
Brooklyn, New York, United States, 11229
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10
SOAR Clinical Study Site
Memphis, Tennessee, United States, 38119
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11
SOAR Clinical Study Site
Austin, Texas, United States, 78737
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Research Team
N
Newleos Therapeutics Clinical Trial Team
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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