[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659982":3},{"organization":4,"outcomesModule":7,"designInfo":21,"detailedDescription":11,"studyPopulation":11,"armGroups":27,"interventions":36,"overallOfficials":11,"centralContacts":42,"locations":48,"responsibleParty":75,"collaborators":11,"id":77,"slug":78,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":11,"eligibilityCriteria":83,"healthyVolunteers":79,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":11,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":96,"overallStatus":97,"whyStopped":11,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Gasherbrum Bio, Inc., a wholly owned subsidiary of Structure Therapeutics","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":11,"otherOutcomes":11},[9,13,15,17,19,20],{"measure":10,"description":11,"timeFrame":12},"PK parameters including but not limited to AUC0-t",null,"Baseline to Day 5 (Part 1)",{"measure":14,"description":11,"timeFrame":12},"PK parameters including but not limited to AUC0-inf",{"measure":16,"description":11,"timeFrame":12},"PK parameters including but not limited to Cmax",{"measure":10,"description":11,"timeFrame":18},"Baseline to Day 5 (Part 2)",{"measure":14,"description":11,"timeFrame":18},{"measure":16,"description":11,"timeFrame":18},{"allocation":22,"interventionModel":23,"interventionModelDescription":11,"primaryPurpose":24,"observationalModel":11,"timePerspective":11,"maskingInfo":25},"NON_RANDOMIZED","SEQUENTIAL","OTHER",{"masking":26,"maskingDescription":11,"whoMasked":11},"NONE",[28,33],{"label":29,"type":30,"description":11,"interventionNames":31},"Participants will receive aleniglipron administered orally Part 1","EXPERIMENTAL",[32],"Drug: Aleniglipron",{"label":34,"type":30,"description":11,"interventionNames":35},"Participants will receive aleniglipron administered orally Part 2",[32],[37],{"type":38,"name":39,"description":40,"armGroupLabels":41,"otherNames":11},"DRUG","Aleniglipron","administered orally",[29,34],[43],{"name":44,"role":45,"phone":46,"phoneExt":11,"email":47},"Medical Director","CONTACT","650-457-1959","GSBRClinicalTrials@Structuretx.com",[49,64],{"facility":50,"status":11,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Research Site","Orlando","Florida","32809","United States","US",{"type":57,"coordinates":58},"Point",[59,60],-81.37924,28.53834,{"lat":60,"lon":59},[63],{"name":44,"role":45,"phone":46,"phoneExt":11,"email":47},{"facility":50,"status":11,"city":65,"state":66,"zip":67,"country":54,"countryCode":55,"cosmosGeoPoint":68,"geoPoint":72,"contacts":73},"San Antonio","Texas","78215",{"type":57,"coordinates":69},[70,71],-98.49363,29.42412,{"lat":71,"lon":70},[74],{"name":44,"role":45,"phone":46,"phoneExt":11,"email":47},{"type":76,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100659982","phase-1-aleniglipron-hepatic-impairment-study-100659982",false,"NCT07872033","Aleniglipron Hepatic Impairment Study","A Phase 1, Single-Dose, Open-Label Study to Evaluate the Effect of Mild, Moderate, and Severe Hepatic Impairment on Aleniglipron Pharmacokinetics","Inclusion Criteria:\n\n1. Is an adult, male or female, ≥ 18 to 85 years of age (inclusive), at screening.\n2. Female and male participants must follow protocol-specified contraception guidance as described in Section 5.4.2.1 and Section 5.4.2.2.\n3. Is a continuous non-smoker or smoker (≤ 10 cigarettes per day or equivalent) for at least 3 months prior to dosing. Participants must agree to maintain the same smoking status (i.e., smoker or non-smoker) from screening and until after the last PK sample collection.\n4. BMI ≥ 17.0 and ≤ 40.0 kg\u002Fm2 and weight of at least 40.0 kg at screening.\n5. Understands the study procedures in the ICF and be willing and able to comply with the protocol and communicate effectively with study personnel.\n\nExclusion Criteria:\n\n1. Is mentally or legally incapacitated or has significant emotional problems at the time of screening or expected during the conduct of the study.\n2. History or presence of alcohol or drug abuse (including participants with symptoms of cannabis disorder) within the past 6 months prior to the dosing.\n3. History or presence of hypersensitivity or idiosyncratic reaction to the study drug or related compounds.\n4. Female participant with a positive serum pregnancy test at screening or at check-in or who is lactating or breastfeeding.\n5. Has positive drug results at screening or at check-in, unless the positive drug screen is due to prescription drug use that is approved by the PI or designee. Participants with a positive result for cannabinoids may be enrolled at the discretion of the PI or designee and the Sponsor.\n6. Has taken medications intended to promote weight loss within 3 months or 5 half-lives, whichever is longer, prior to screening, including, but not limited to GLP-1 RAs.","ALL","18 Years","85 Years",{"count":88,"type":89},36,"ESTIMATED","INTERVENTIONAL",[92],"PHASE1","The purpose of this study is to evaluate the PK of aleniglipron in participants with Hepatic Impairment to establish scientifically guided dosing recommendations in these special patient populations.",[95],"Hepatic Impairment",[95],"NOT_YET_RECRUITING","2026-10-07",{"date":100,"type":101},"2026-10-13","ACTUAL",{"date":103,"type":89},"2026-10",{"date":105,"type":89},"2027-12",{"name":5,"class":6},2]