[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Newleos Therapeutics, Inc.\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":67},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,41],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100632946","phase-1-study-of-ntx-2001-on-alcohol-consumption-in-alcohol-use-disorder-100632946",false,"NCT07520292","Study of NTX-2001 on Alcohol Consumption in Alcohol Use Disorder","The Effects of NTX-2001, a Novel TAAR1 Partial Agonist, on Alcohol Consumption in Adults With Alcohol Use Disorder: A Phase 1b, Randomized, Placebo-Controlled, Proof-of-Concept Study","Inclusion Criteria:\n\n1. Has provided written informed consent for the study and is willing to comply with all requirements of the protocol\n2. English speaker\n3. Male or female, ≥21 and ≤60 years of age.\n4. Has a body mass index (BMI) 18 to 35 kg\u002Fm2 inclusive.\n5. Meets DSM-5 criteria for Alcohol Use Disorder (AUD) confirmed by Mini-International Neuropsychiatric Interview (MINI).\n6. If participant is of childbearing potential, must commit to practicing highly effective methods of birth control during the study and at least 14 days after the last dose.\n\nExclusion Criteria:\n\n1. Currently seeking alcohol treatment or have been in alcohol treatment within the past 6 months\n2. Reports disliking spirits (hard liquor)\n3. Current diagnosis of substance use disorder, except for tobacco use disorder or mild cannabis use disorder as defined by the Diagnostic and Statistical Manual of Mental Disorders 5th Edition (DSM-5)\n4. Past or current diagnosis of schizophrenia spectrum or other psychotic disorder as defined by the DSM-5\n5. Receiving psychotropics regularly, except for a stable dose of an antidepressant for at least 2 months prior to Screening\n6. Is at risk for suicidal ideation as per C-SSRS\n7. Has moderate or severe hepatic impairment\n8. Has moderate or severe renal impairment\n9. Women who are pregnant or women who are currently breastfeeding unless they plan to stop breastfeeding for the duration of the study","ALL","21 Years","60 Years",{"count":20,"type":21},50,"ESTIMATED","INTERVENTIONAL",[24],"PHASE1","The primary goal of this Phase 1b clinical trial is to evaluate the effects of a novel TAAR1 receptor partial agonist (NTX-2001) in adults with Alcohol Use Disorder (AUD). The main questions this trial aims to answer are:\n\n* Does NTX-2001 affect alcohol consumption in adults with AUD?\n* Is NTX-2001 safe and well tolerated in adults with AUD?\n\nResearchers will compare the effects of NTX-2001 with matching placebo (look-alike capsule that contains no drug).\n\nParticipants will:\n\n* Take NTX-2001 or matching placebo every day for 2 weeks\n* Visit the clinic 4 times over the course of 10 weeks",[27],"Alcohol Use Disorder","RECRUITING","2026-04-03",{"date":31,"type":32},"2026-04-09","ACTUAL",{"date":34,"type":32},"2026-03-20",{"date":36,"type":21},"2027-03",{"name":38,"class":39},"Newleos Therapeutics, Inc.","INDUSTRY",1,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":55,"conditions":56,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":66},"100617835","phase-2-a-study-of-ntx-1472-in-social-anxiety-disorder-100617835","NCT07323784","A Study of NTX-1472 in 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","SOAR","Key Inclusion Criteria\n\n* Has provided written informed consent for the study and is willing to comply with all requirements of the protocol\n* English speaker\n* Male or female, ≥18 and ≤65 years of age\n* 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).\n* Clinician-administered Liebowitz Social Anxiety Score (LSAS) total score ≥70 at Screening\n* Clinician-rated Hamilton Depression Rating Scale (HDRS 17) (17 items) total score \\\u003C16 at Screening\n* 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.\n\nKey Exclusion Criteria\n\n* Current diagnosis of performance-only SAD as defined by the DSM-5 and confirmed by the SCID-5-CT.\n* 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\u002Fhyperactivity disorder, Autism spectrum disorder, Major depressive disorder, Personality disorder, Post-traumatic stress disorder.\n* 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).\n* Receiving daily psychotropics within 4 weeks of Screening\n* Is at risk for suicidal ideation as per C-SSRS\n* Has moderate or severe hepatic impairment\n* Has severe renal impairment\n* Women who are pregnant or women who are currently breastfeeding unless they are willing to stop breastfeeding for the duration of the study.","18 Years","65 Years",{"count":52,"type":21},100,[54],"PHASE2","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:\n\n* Is NTX-1472 safe and well tolerated in adults with SAD?\n* How effectively does NTX-1472 treat adults with SAD?\n\nResearchers will compare the effects of NTX-1472 with matching placebo (a look-alike capsule that contains no drug).\n\nParticipants will:\n\n* Take NTX-1472 or matching placebo every day for 8 weeks\n* Visit the clinic 6 times over the course of 14 weeks for checkups and tests",[57],"Social Anxiety Disorder (SAD)","2026-01-16",{"date":60,"type":32},"2026-01-21",{"date":62,"type":32},"2025-12-09",{"date":64,"type":21},"2027-01",{"name":38,"class":39},11,""]