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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
Led by Newleos Therapeutics, Inc. · Updated on 2026-01-21
100
Participants Needed
11
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
Researchers are studying the effects of a new drug called NTX-1472, which is a V1a receptor antagonist, in adults diagnosed with Social Anxiety Disorder (SAD). This Phase 2 clinical trial aims to find out if NTX-1472 is safe, well tolerated, and effective in treating SAD. Participants will be compared to a placebo group to assess the drug's impact on this condition. Participants will take either NTX-1472 or a matching placebo capsule daily for 8 weeks. The study involves a total of 6 clinic visits over 14 weeks for health checkups and various tests. The trial uses a randomized, double-blind, placebo-controlled design to fairly assess the drug's effects. During the study, participants will undergo several assessments including the clinician-administered Liebowitz Social Anxiety Scale (LSAS), Hamilton Anxiety Rating Scale, and other anxiety, depression, stress, loneliness, and sleep quality measures. Researchers will track safety by monitoring treatment-emergent adverse events from the start to week 8. The total participation time spans over 14 weeks with regular visits to ensure thorough evaluation and monitoring.
CONDITIONS
Brief 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 agree to follow study rules
- English speaker
- Male or female aged 18 to 65 years
- Diagnosed with generalized Social Anxiety Disorder (SAD) confirmed by DSM-5 and clinical interview
- Liebowitz Social Anxiety Score (LSAS) total score of at least 70 at screening
- Hamilton Depression Rating Scale (HDRS 17) score less than 16 at screening
- If able to bear children, agree to use effective birth control during the study and for 14 days after last dose
You will not qualify if you...
- Diagnosis of performance-only Social Anxiety Disorder
- Current diagnosis of ADHD, Autism spectrum disorder, Major depressive disorder, Personality disorder, or PTSD
- Past or current diagnosis of bipolar disorder, feeding and eating disorder (adult), OCD, schizophrenia spectrum or other psychotic disorder, substance use disorder within 12 months
- Use of daily psychotropic drugs within 4 weeks before screening
- Risk of suicidal ideation as per C-SSRS
- Moderate or severe liver problems
- Severe kidney problems
- Pregnant or breastfeeding women unwilling to stop breastfeeding during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive daily doses of NTX-1472 or placebo for social anxiety disorder.
Weekly visits for up to 8 weeks
Trial Site Locations
Total: 11 locations
1
SOAR Clinical Study Site
Pheonix, Arizona, United States, 85012
Actively Recruiting
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
Actively Recruiting
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
Actively Recruiting
10
SOAR Clinical Study Site
Memphis, Tennessee, United States, 38119
Actively Recruiting
11
SOAR Clinical Study Site
Austin, Texas, United States, 78737
Actively Recruiting
Research Team
N
Newleos Therapeutics Clinical Trial Team
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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