NCT07323784RecruitingPhase 2
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
Newleos Therapeutics, Inc.11 sites in 1 country100 target enrollmentStarted: December 9, 2025Last updated:
Interventions
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 11
- Primary Endpoint
- Incidence and severity of treatment-emergent adverse events (TEAEs)
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Arms & Interventions
Placebo
Placebo Comparator
Intervention: Placebo (Drug)
NTX-1472
Experimental
Intervention: NTX-1472 (Drug)
Outcomes
Primary Outcomes
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time Frame: Baseline to Week 8
Secondary Outcomes
- Change in University of California, Los Angeles Loneliness Scale 10-items (UCLA LS 10) score(Baseline to Week 8)
- 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)
- Clinical Global Impression - Severity (CGI-S) score(Baseline to Week 8)
- Patient Global Impression - Severity (PGI-S) score(Baseline to Week 8)
- Change in Depression Anxiety Stress Scale - 21 items (DASS-21, Stress subscale only)(Baseline to Week 8)
- Change in Pittsburgh Sleep Quality Index (PSQI) global score(Baseline to Week 8)
- Change in State-Trait Anxiety Inventory (STAI) state(Baseline to Week 8)
- Change in University of California, Los Angeles Loneliness Scale 9-items (UCLA LS 10) score(Baseline to Week 8)
Investigators
Study Sites (11)
Loading locations...
Similar Trials
Recruiting
Phase 1
A Study of DB-1324 in Advanced/Metastatic Gastrointestinal TumorsNCT07263594DualityBio Inc.127
Recruiting
Phase 2
NWRD06 DNA Plasmid for HCC After Curative Resection.NCT07324304Newish Technology (Beijing) Co., Ltd.30
Not yet recruiting
Phase 1
Study of QLC5513 in Combination With Epalolimab Tovolimab (QL1706) ± Platinum in Patients With Advanced or Metastatic Malignant Solid TumorsNCT07272590Qilu Pharmaceutical Co., Ltd.290
Recruiting
Phase 2
Firmonertinib Combined With Definitive Radiotherapy in Stage III Unresectable EGFR Uncommon Mutant Pulmonary AdenocarcinomaNCT07314216Hunan Cancer Hospital15
Recruiting
Phase 2
A Study of BL-M07D1 in Combination With Pembrolizumab in Patients With Unresectable Locally Advanced or Metastatic HER2-Overexpressing Non-Squamous NSCLCNCT07264816Sichuan Baili Pharmaceutical Co., Ltd.80