Social Anxiety Disorder (SAD)Phase 2SOARNCT07323784
A Study of NTX-1472 in Social Anxiety Disorder
A Phase 2 study testing NTX-1472 in people with Social Anxiety Disorder (SAD), run by Newleos Therapeutics, Inc. at 11 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Social Anxiety Disorder (SAD)
- What is being tested?
- NTX-1472
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 11 sitesUnited States
- Study dates
- 9 Dec 2025to Jan 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 10 recruiting
- Recruiting
SOAR Clinical Study Site
Austin, Texas, 78737
SOAR Clinical Study Site, 978-780-5937, clinicaltrials@newleos.com
- Recruiting
SOAR Clinical Study Site
Boston, Massachusetts, 02131
SOAR Clinical Study Site, 978-780-5937, clinicaltrials@newleos.com
- Recruiting
SOAR Clinical Study Site
Brooklyn, New York, 11229
SOAR Clinical Study Site, 978-780-5937, clinicaltrials@newleos.com
- Recruiting
SOAR Clinical Study Site
Encino, California, 91316
SOAR Clinical Study Site, 978-780-5937, clinicaltrials@newleos.com
- Recruiting
SOAR Clinical Study Site
Jacksonville, Florida, 32256
SOAR Clinical Study Site, 978-780-5937, clinicaltrials@newleos.com
- Active, not recruiting
SOAR Clinical Study Site
Las Vegas, Nevada, 89119
- Recruiting
SOAR Clinical Study Site
Los Angeles, California, 90025
SOAR Clinical Study Site, 978-780-5937, clinicaltrials@newleos.com
- Recruiting
SOAR Clinical Study Site
Memphis, Tennessee, 38119
SOAR Clinical Study Site, 978-780-5937, clinicaltrials@newleos.com
- Recruiting
SOAR Clinical Study Site
Oceanside, California, 92056
SOAR Clinical Study Site, 978-780-5937, clinicaltrials@newleos.com
- Recruiting
SOAR Clinical Study Site
San Jose, California, 95124
SOAR Clinical Study Site, 978-780-5937, clinicaltrials@newleos.com
- Recruiting
SOAR Clinical Study Site
Tampa, Florida, 33615
SOAR Clinical Study Site, 978-780-5937, clinicaltrials@newleos.com
About this study
Official title: 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
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
- Social Anxiety Disorder (SAD)
- Being tested
- NTX-1472, Placebo
- Medical subject headings
- Phobia, Social
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTX-1472Drug
Daily (QD) x 8 weeks.
PlaceboDrug
Daily (QD) x 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NTX-1472 | Experimental | Not described Receives: Drug: NTX-1472 |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of treatment-emergent adverse events (TEAEs)
Measured: Baseline to Week 8
Secondary outcomes (11)
Change in the clinician-administered Liebowitz Social Anxiety Scale (LSAS) total score
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.
Measured: Baseline to Week 8
Change in LSAS Fear/Anxiety and Avoidance subscale score
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.
Measured: Baseline to Week 8
Number and percentage of participants who are responders (≥50% improvement from Baseline [Day 1]) based on the LSAS total score
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.
Measured: Baseline to Week 8
Number and percentage of participants who are remitters based on an LSAS total score of <30
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered scale that is designed to record the severity of subjective anxiety and avoidance behavior across a range of social interaction and performance situations. The fear and avoidance subscale scores range from 0 to 72 each. The total score ranges from 0 to 144. Higher scores indicate greater severity of social anxiety.
Measured: Baseline to Week 8
Change in Hamilton Anxiety Rating Scale (HAM-A) total score
The Hamilton Anxiety Rating Scale (HAM-A) is a clinician-administered scale that is designed to rate severity of anxiety. The total score ranges from 0 to 56. Higher scores indicate greater severity of anxiety.
Measured: Baseline to Week 8
Clinical Global Impression - Severity (CGI-S) score
The Clinical Global Impression - Severity (CGI-S) score is rated on a 7-point scale, using a range of responses from 1 (normal, not at all ill) through to 7 (among the most extremely ill patients).
Measured: Baseline to Week 8
Patient Global Impression - Severity (PGI-S) score
The Patient Global Impression - Severity (CGI-S) score is rated on a 7-point scale, using a range of responses from 1 (not present) through to 7 (extremely severe).
Measured: Baseline to Week 8
Change in Depression Anxiety Stress Scale - 21 items (DASS-21, Stress subscale only)
The Depression Anxiety Stress Scale - 21 items (DASS-21), Stress subscale ranges from 0 to 21, with higher scores indicating greater stress severity.
Measured: Baseline to Week 8
Change in University of California, Los Angeles Loneliness Scale 10-items (UCLA LS 10) score
The University of California, Los Angeles Loneliness Scale 10-items (UCLA LS 10) score ranges from 10 to 40, with higher scores indicating greater perceived loneliness.
Measured: Baseline to Week 8
Change in Pittsburgh Sleep Quality Index (PSQI) global score
The Pittsburgh Sleep Quality Index (PSQI) global score ranges from 0 to 21, with higher scores indicating worse sleep quality.
Measured: Baseline to Week 8
Change in State-Trait Anxiety Inventory (STAI) state
The State-Trait Anxiety Inventory (STAI) state score ranges from 20 to 80, with higher scores indicating greater anxiety in the moment.
Measured: Baseline to Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start9 Dec 2025
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Anxiety Disorder (SAD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Newleos Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07323784
- Sponsor's protocol ID
- NTX-1472-201
- Acronym
- SOAR
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07323784
- Acronym / sponsor ID
- SOAR / NTX-1472-201
- Conditions
- Social Anxiety Disorder (SAD)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Newleos Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NTX-1472 | Experimental | Drug: NTX-1472 |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NTX-1472Daily (QD) x 8 weeks. | Drug | NTX-1472 |
| PlaceboDaily (QD) x 8 weeks. | Drug | Placebo |
Primary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: Baseline to Week 8
11 secondary outcomes
Change in the clinician-administered Liebowitz Social Anxiety Scale (LSAS) total score
Time frame: Baseline to Week 8
Change in LSAS Fear/Anxiety and Avoidance subscale score
Time frame: Baseline to Week 8
Number and percentage of participants who are responders (≥50% improvement from Baseline [Day 1]) based on the LSAS total score
Time frame: Baseline to Week 8
Number and percentage of participants who are remitters based on an LSAS total score of <30
Time frame: Baseline to Week 8
Change in Hamilton Anxiety Rating Scale (HAM-A) total score
Time frame: Baseline to Week 8
Clinical Global Impression - Severity (CGI-S) score
Time frame: Baseline to Week 8
Patient Global Impression - Severity (PGI-S) score
Time frame: Baseline to Week 8
Change in Depression Anxiety Stress Scale - 21 items (DASS-21, Stress subscale only)
Time frame: Baseline to Week 8
Change in University of California, Los Angeles Loneliness Scale 10-items (UCLA LS 10) score
Time frame: Baseline to Week 8
Change in Pittsburgh Sleep Quality Index (PSQI) global score
Time frame: Baseline to Week 8
Change in State-Trait Anxiety Inventory (STAI) state
Time frame: Baseline to Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing NTX-1472 in people with Social Anxiety Disorder (SAD), run by Newleos Therapeutics, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Newleos Therapeutics Clinical Trial Team (978-780-5937, clinicaltrials@newleos.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of treatment-emergent adverse events (TEAEs) (time frame: Baseline to Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.