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RecruitingPhase 2

A Study of NTX-1472 in Social Anxiety Disorder

Newleos Therapeutics, Inc. · NCT07323784

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–65 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 2
Target enrollment
100
US sites recruiting
10
Study start
December 9, 2025
Record last updated
July 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study 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

Being studied: NTX-1472; Placebo

Conditions: Social Anxiety Disorder (SAD)

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full 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.

Recruiting US locations

  • SOAR Clinical Study Site

    Encino, CA 91316

    Site contact: SOAR Clinical Study Site · 978-780-5937 · clinicaltrials@newleos.com

  • SOAR Clinical Study Site

    Los Angeles, CA 90025

    Site contact: SOAR Clinical Study Site · 978-780-5937 · clinicaltrials@newleos.com

  • SOAR Clinical Study Site

    Oceanside, CA 92056

    Site contact: SOAR Clinical Study Site · 978-780-5937 · clinicaltrials@newleos.com

  • SOAR Clinical Study Site

    San Jose, CA 95124

    Site contact: SOAR Clinical Study Site · 978-780-5937 · clinicaltrials@newleos.com

  • SOAR Clinical Study Site

    Jacksonville, FL 32256

    Site contact: SOAR Clinical Study Site · 978-780-5937 · clinicaltrials@newleos.com

  • SOAR Clinical Study Site

    Tampa, FL 33615

    Site contact: SOAR Clinical Study Site · 978-780-5937 · clinicaltrials@newleos.com

  • SOAR Clinical Study Site

    Boston, MA 02131

    Site contact: SOAR Clinical Study Site · 978-780-5937 · clinicaltrials@newleos.com

  • SOAR Clinical Study Site

    Brooklyn, NY 11229

    Site contact: SOAR Clinical Study Site · 978-780-5937 · clinicaltrials@newleos.com

  • SOAR Clinical Study Site

    Memphis, TN 38119

    Site contact: SOAR Clinical Study Site · 978-780-5937 · clinicaltrials@newleos.com

  • SOAR Clinical Study Site

    Austin, TX 78737

    Site contact: SOAR Clinical Study Site · 978-780-5937 · clinicaltrials@newleos.com

Study contacts (from the official record)

  • Newleos Therapeutics Clinical Trial Team · 978-780-5937 · clinicaltrials@newleos.com
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A Study of NTX-1472 in Social Anxiety Disorder (NCT07323784) | Bored Studies