[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659258":3},{"organization":4,"outcomesModule":7,"designInfo":22,"detailedDescription":11,"studyPopulation":11,"armGroups":31,"interventions":42,"overallOfficials":11,"centralContacts":50,"locations":55,"responsibleParty":95,"collaborators":11,"id":97,"slug":98,"hasResults":99,"nctId":100,"briefTitle":101,"officialTitle":102,"acronym":11,"eligibilityCriteria":103,"healthyVolunteers":99,"sex":104,"minAge":105,"maxAge":11,"enrollmentInfo":106,"targetDuration":11,"studyType":109,"phases":110,"briefSummary":112,"conditions":113,"keywords":11,"overallStatus":58,"whyStopped":11,"lastUpdateSubmitDate":115,"lastUpdatePostDateStruct":116,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},{"fullName":5,"class":6},"Sagimet Biosciences Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":17},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Proportion of participants achieving EGSS success, defined as a score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from their baseline score",null,"Week 12",{"measure":14,"description":11,"timeFrame":12},"Absolute change from baseline in inflammatory lesion count (ILC)",{"measure":16,"description":11,"timeFrame":12},"Absolute change from baseline in non-inflammatory lesion count (ILC)",[18],{"measure":19,"description":20,"timeFrame":21},"Safety and tolerability (Open-Label Extension)","Incidence of treatment-emergent adverse events and serious adverse events; change from baseline in safety parameters","Week 52",{"allocation":23,"interventionModel":24,"interventionModelDescription":11,"primaryPurpose":25,"observationalModel":11,"timePerspective":11,"maskingInfo":26},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":27,"maskingDescription":11,"whoMasked":28},"DOUBLE",[29,30],"PARTICIPANT","INVESTIGATOR",[32,37],{"label":33,"type":34,"description":11,"interventionNames":35},"Denifanstat","EXPERIMENTAL",[36],"Drug: Denifanstat",{"label":38,"type":39,"description":11,"interventionNames":40},"Placebo","PLACEBO_COMPARATOR",[41],"Other: Placebo",[43,47],{"type":44,"name":33,"description":45,"armGroupLabels":46,"otherNames":11},"DRUG","Oral, once daily",[33],{"type":48,"name":38,"description":45,"armGroupLabels":49,"otherNames":11},"OTHER",[38],[51],{"name":52,"role":53,"phone":54,"phoneExt":11,"email":11},"Study Director","CONTACT","(650) 561-8675",[56,70,79,88],{"facility":57,"status":58,"city":59,"state":60,"zip":61,"country":62,"countryCode":63,"cosmosGeoPoint":64,"geoPoint":69,"contacts":11},"Sagimet Investigative Site","RECRUITING","Bryant","Arkansas","72022","United States","US",{"type":65,"coordinates":66},"Point",[67,68],-92.48905,34.59593,{"lat":68,"lon":67},{"facility":57,"status":58,"city":71,"state":72,"zip":73,"country":62,"countryCode":63,"cosmosGeoPoint":74,"geoPoint":78,"contacts":11},"Fremont","California","94538",{"type":65,"coordinates":75},[76,77],-121.98857,37.54827,{"lat":77,"lon":76},{"facility":57,"status":58,"city":80,"state":81,"zip":82,"country":62,"countryCode":63,"cosmosGeoPoint":83,"geoPoint":87,"contacts":11},"Doral","Florida","33126",{"type":65,"coordinates":84},[85,86],-80.35533,25.81954,{"lat":86,"lon":85},{"facility":57,"status":58,"city":89,"state":81,"zip":82,"country":62,"countryCode":63,"cosmosGeoPoint":90,"geoPoint":94,"contacts":11},"Miami",{"type":65,"coordinates":91},[92,93],-80.19366,25.77427,{"lat":93,"lon":92},{"type":96,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659258","phase-3-phase-3-study-of-denifanstat-in-participants-with-moderate-to-severe-acne-100659258",false,"NCT07863193","Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne","A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Design Trial to Evaluate the Safety and Efficacy of Denifanstat in Participants With Moderate to Severe Acne Vulgaris","Inclusion Criteria:\n\n1. Must be willing and able to participate in the trial and provide written informed consent or assent\n2. Aged ≥12 years on the date that written informed consent\u002F assent is provided\n3. Moderate to severe acne vulgaris based on the following criteria at screening:\n\n   1. The EGSS at screening of 3 or 4.\n\n      AND\n   2. Number of facial skin lesions:\n\n      * 30 to 75 inflammatory lesions\n      * 30 to 100 noninflammatory lesions\n4. All participants with their partners, if any, must agree to the use of an acceptable method of highly effective contraception. Women of childbearing potential (WOCBP) must not be pregnant or breastfeeding, must not plan to become pregnant during the study, and must use 2 forms of birth control, one being a barrier method, or be sexually abstinent.\n\nExclusion Criteria:\n\n1. Presence of \\>2 facial cysts\u002F nodules\n2. Cystic acne, acne fulminans or acne conglobata\n3. Other significant skin diseases that may affect the efficacy evaluation or require co-treatment\n4. History of clinically significant dry eye, such as Ocular Surface Disease Index (OSDI) ≥33, or corneal staining ≥ grade III on Oxford Grading Scale, chronic dry eye, or other corneal abnormality\n5. Use of concomitant strong cytochrome P450 (CYP) 3A4 inducers and strong or moderate inhibitors within 2 weeks prior to Day 1 the trial except Paxlovid®\n6. Use of a glucagon-like-peptide 1 (GLP-1) agonist for \\\u003C12 weeks prior to first dose of trial medication\n7. Use of any of the following:\n\n   1. Introduction of any drug known to prolong QT interval corrected for heart rate (QTC)\n   2. Sensitive substrates of P-glycoprotein (P-gp) and breast cancer resistant protein (BCRP)\n   3. Herbs and supplements such as St John's Wort or grapefruit juice.\n8. Use of concomitant acne treatments unless appropriate washout period is documented","ALL","12 Years",{"count":107,"type":108},800,"ESTIMATED","INTERVENTIONAL",[111],"PHASE3","The purpose of this study is to evaluate the safety and efficacy of denifanstat compared with matching placebo in participants with moderate to severe acne vulgaris who are ≥12 years of age. After the 12-week treatment phase, a subset of approximately 530 participants will have the option to consent to an open-label extension phase for an additional 40 weeks of treatment.",[114],"Acne Vulgaris","2026-10-02",{"date":117,"type":118},"2026-10-07","ACTUAL",{"date":120,"type":108},"2026-10",{"date":122,"type":108},"2028-04",{"name":5,"class":6},4]