[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100656722":3},{"organization":4,"outcomesModule":7,"designInfo":43,"detailedDescription":11,"studyPopulation":11,"armGroups":54,"interventions":65,"overallOfficials":74,"centralContacts":78,"locations":11,"responsibleParty":84,"collaborators":11,"id":86,"slug":87,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":11,"eligibilityCriteria":92,"healthyVolunteers":88,"sex":93,"minAge":94,"maxAge":11,"enrollmentInfo":95,"targetDuration":11,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":113,"whyStopped":11,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":11},{"fullName":5,"class":6},"Regeneron Pharmaceuticals","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percent change in total Abscess and inflammatory Nodule (AN) count",null,"From baseline to week 52",[14,16,19,21,23,25,27,29,32,34,37,39,41],{"measure":15,"description":11,"timeFrame":12},"Percent change in body weight",{"measure":17,"description":11,"timeFrame":18},"Achieving HiSCR50 (≥50% reduction from baseline in total AN counts with no increase in abscess count and no increase in draining tunnel count)","At week 52",{"measure":20,"description":11,"timeFrame":12},"Absolute change in weekly average Skin Pain Numeric Rating Scale (NRS)",{"measure":22,"description":11,"timeFrame":12},"Percent change in weekly average Skin Pain NRS",{"measure":24,"description":11,"timeFrame":12},"Achieving ≥3-point reduction in weekly average Skin Pain NRS",{"measure":26,"description":11,"timeFrame":12},"Absolute change in Dermatology Life Quality Index (DLQI)",{"measure":28,"description":11,"timeFrame":18},"Achieving minimum clinically important difference (reduction of ≥4 points from baseline score) in the DLQI total score",{"measure":30,"description":11,"timeFrame":31},"Absolute change in high-sensitivity C-Reactive Protein (hsCRP)","From baseline up to week 52",{"measure":33,"description":11,"timeFrame":31},"Percent change in hsCRP",{"measure":35,"description":11,"timeFrame":36},"Concentrations of olatorepatide","Up to week 56",{"measure":38,"description":11,"timeFrame":36},"Occurrence of Anti-Drug Antibodies (ADAs) to olatorepatide",{"measure":40,"description":11,"timeFrame":36},"Magnitude of ADAs to olatorepatide",{"measure":42,"description":11,"timeFrame":36},"Occurrence of Treatment-Emergent Adverse Events (TEAEs)",{"allocation":44,"interventionModel":45,"interventionModelDescription":11,"primaryPurpose":46,"observationalModel":11,"timePerspective":11,"maskingInfo":47},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":48,"maskingDescription":11,"whoMasked":49},"QUADRUPLE",[50,51,52,53],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[55,60],{"label":56,"type":57,"description":11,"interventionNames":58},"Olatorepatide","EXPERIMENTAL",[59],"Drug: Olatorepatide",{"label":61,"type":62,"description":11,"interventionNames":63},"Placebo","PLACEBO_COMPARATOR",[64],"Drug: Placebo",[66,72],{"type":67,"name":56,"description":68,"armGroupLabels":69,"otherNames":70},"DRUG","Administered per the protocol",[56],[71],"HS-20094",{"type":67,"name":61,"description":68,"armGroupLabels":73,"otherNames":11},[61],[75],{"name":76,"affiliation":5,"role":77},"Clinical Trial Management","STUDY_DIRECTOR",[79],{"name":80,"role":81,"phone":82,"phoneExt":11,"email":83},"Clinical Trials Administrator","CONTACT","844-734-6643","clinicaltrials@regeneron.com",{"type":85,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100656722","phase-2-efficacy-and-safety-of-olatorepatide-versus-placebo-in-adults-with-moderate-to-severe-hidradenitis-suppurativa-living-with-overweight-or-obesity-100656722",false,"NCT07830329","Efficacy and Safety of Olatorepatide Versus Placebo in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity","A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group 52-Week Trial to Investigate the Efficacy and Safety of Olatorepatide, a GLP-1\u002FGIP Receptor Agonist, in Adults With Moderate to Severe Hidradenitis Suppurativa Living With Overweight or Obesity","Key Inclusion Criteria:\n\n1. Diagnosis of HS based on:\n\n   1. Documented or reported history of HS for ≥6 months prior to baseline visit\n   2. Confirmation of HS by the investigator during physical examination at screening\n2. HS lesions present in at least 2 distinct anatomic areas as described in the protocol\n3. Moderate to severe HS, defined as a total of ≥5 inflammatory lesions (ie, number of abscesses plus number of inflammatory nodules) at both screening (visit 1) and baseline (visit 2)\n4. Agree to daily use of over-the-counter topical antiseptics (eg, chlorhexidine gluconate, benzoyl peroxide, or diluted bleach \\[bath\\], or alternative antiseptic agents in accordance with local\u002Fcountry guidelines) applied to HS-affected areas as described in the protocol\n5. Body Mass Index (BMI) ≥27.0 kg\u002Fm2 at screening\n\nKey Exclusion Criteria:\n\n1. Has a sensitivity (or history of hypersensitivity reactions) to any of the trial interventions, or components thereof, or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the trial\n2. Cardiovascular or cerebrovascular events or procedures within 90 days prior to screening, including myocardial infarction, hospitalization for unstable angina, coronary artery bypass graft, percutaneous coronary intervention as described in the protocol\n3. Current heart failure classified as being in NYHA Class IV at screening\n4. History of chronic pancreatitis or acute pancreatitis\n5. Presence of serious Gastrointestinal (GI) disorders (eg, active peptic ulcer, inflammatory bowel disease) at screening\n6. Have a previous or current diagnosis of Type 1 Diabetes (T1D) or any other type of diabetes except Type 2 Diabetes (T2D) as described in the protocol\n\nNote: Other Protocol Defined Inclusion\u002F Exclusion Criteria Apply","ALL","18 Years",{"count":96,"type":97},300,"ESTIMATED","INTERVENTIONAL",[100],"PHASE2","This study will test an experimental Regeneron drug called olatorepatide (\"study drug\") to see if it can help treat Hidradenitis Suppurativa (HS).\n\nIn this study, olatorepatide is being tested in people with HS and living with overweight or obesity to see if it helps improve their HS symptoms and quality of life and helps support weight loss.\n\nThe study is looking at:\n\n* What side effects olatorepatide might cause\n* How well olatorepatide works\n* How much olatorepatide is in the blood at different times\n* If the body makes antibodies to olatorepatide, which may cause olatorepatide to not work as well",[103],"Hidradenitis Suppurativa",[105,106,107,108,109,110,111,112],"Acne inversa","Skin problems","Inflammatory skin lesions","Painful nodules and abscesses","HS inflammatory nodules","Abscesses","Overweight or obesity","Weight loss","NOT_YET_RECRUITING","2026-09-15",{"date":116,"type":117},"2026-09-21","ACTUAL",{"date":119,"type":97},"2026-10-30",{"date":121,"type":97},"2028-12-22",{"name":5,"class":6}]