NTX-1472 for adults with social anxiety disorder
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
This study will test whether the drug NTX-1472 is safe and helps reduce symptoms in adults with generalized social anxiety disorder.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Newleos Therapeutics, Inc. Industry-sponsored |
| Locations | 11 sites (Pheonix, Arizona and 10 other locations) |
| Trial ID | NCT07323784 on ClinicalTrials.gov |
What this trial studies
This Phase 2, randomized, placebo-controlled trial gives adults with generalized social anxiety disorder either NTX-1472 or a matching placebo once daily for 8 weeks and follows them for a total of 14 weeks. Participants attend six clinic visits for safety checks, symptom ratings, and other tests. Eligibility requires a confirmed DSM-5 diagnosis of generalized SAD and a high baseline Liebowitz Social Anxiety Scale (LSAS) score. The trial's main outcomes are safety/tolerability and change in social anxiety symptoms compared with placebo.
Who should consider this trial
Good fit: Adults 18–65 years old with a DSM-5 diagnosis of generalized social anxiety disorder, an LSAS total score of 70 or higher, low depressive symptoms (HDRS-17 <16), and willingness to comply with study procedures and contraception requirements if applicable.
Not a fit: People with performance-only SAD, certain current psychiatric comorbidities, pregnant or breastfeeding individuals, or those unable to attend the scheduled clinic visits are unlikely to qualify or benefit from this trial.
Why it matters
Potential benefit: If successful, NTX-1472 could become a new medication option that meaningfully reduces social anxiety symptoms with an acceptable safety profile.
How similar studies have performed: Vasopressin V1a receptor antagonists are a relatively novel approach for anxiety; preclinical and early-phase work suggest possible benefits, but clinical evidence in social anxiety disorder is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Pheonix, Arizona and 10 other locations
- SOAR Clinical Study Site — Pheonix, Arizona, United States (Recruiting)
- SOAR Clinical Study Site — Encino, California, United States (Recruiting)
- SOAR Clinical Study Site — Los Angeles, California, United States (Recruiting)
- SOAR Clinical Study Site — Oceanside, California, United States (Recruiting)
- SOAR Clinical Study Site — San Jose, California, United States (Recruiting)
- SOAR Clinical Study Site — Jacksonville, Florida, United States (Recruiting)
- SOAR Clinical Study Site — Tampa, Florida, United States (Recruiting)
- SOAR Clinical Study Site — Boston, Massachusetts, United States (Recruiting)
- SOAR Clinical Study Site — Brooklyn, New York, United States (Recruiting)
- SOAR Clinical Study Site — Memphis, Tennessee, United States (Recruiting)
- SOAR Clinical Study Site — Austin, Texas, United States (Recruiting)
Study contacts
- Study coordinator: Newleos Therapeutics Clinical Trial Team
- Email: clinicaltrials@newleos.com
- Phone: 978-780-5937
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.