[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658016":3},{"organization":4,"outcomesModule":7,"designInfo":18,"detailedDescription":27,"studyPopulation":17,"armGroups":28,"interventions":54,"overallOfficials":17,"centralContacts":64,"locations":70,"responsibleParty":85,"collaborators":17,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":17,"eligibilityCriteria":93,"healthyVolunteers":89,"sex":94,"minAge":95,"maxAge":96,"enrollmentInfo":97,"targetDuration":17,"studyType":100,"phases":101,"briefSummary":103,"conditions":104,"keywords":106,"overallStatus":73,"whyStopped":17,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Viking Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":17},[9],{"measure":10,"description":11,"timeFrame":12},"Evaluate the safety of single doses of subcutaneous administration of VK3019","-Incidence of treatment emergent adverse events (TEAEs) and treatment emergent serious adverse events (TESAEs)","36 days",[14],{"measure":15,"description":16,"timeFrame":12},"Evaluate the Pharmacokinetic profile of single doses of subcutaneous administration of VK3019","Pharmacokinetic profile of subcutaneous VK3019 by measuring peak plasma concentration (Cmax)",null,{"allocation":19,"interventionModel":20,"interventionModelDescription":17,"primaryPurpose":21,"observationalModel":17,"timePerspective":17,"maskingInfo":22},"RANDOMIZED","SEQUENTIAL","TREATMENT",{"masking":23,"maskingDescription":17,"whoMasked":24},"DOUBLE",[25,26],"PARTICIPANT","INVESTIGATOR","Approximately 56 participants will enroll into one of 7 cohorts (Cohort 1 through Cohort 7 N=8 per cohort) and will receive either VK3019 or VK3019 matching placebo (for a total of 6 VK3019 and 2 placebo per cohort).\n\nAll dose cohorts will first dose 2 sentinels (1 active and 1 placebo) to be followed by the rest of the cohort (ROC) no sooner than 48 hours following sentinel dosing. In all cohorts, the first 2 enrolled participants (sentinel pair) will be randomized in a 1:1 ratio and in a double-blind fashion, to receive either VK3019 or matching VK3019 placebo. The 2 sentinel participants will be dosed on the same day (Day 1). If deemed safe by the Investigator, a minimum 2 days after sentinel pair dosing, the same dose will be administered to the ROC participants. The rest of the participants within cohort will be randomized 5:1 where 1 is the remaining placebo.\n\nSafety Review Committee (SRC) meetings will be held prior to dose escalation during the study in a blinded fashion. The decisions on dose escalation will be based on safety and laboratory data from each cohort.",[29,36,39,42,45,48,51],{"label":30,"type":31,"description":32,"interventionNames":33},"VK3019 Dose Level 1","EXPERIMENTAL","Single-dose VK3019 or placebo administered subcutaneously",[34,35],"Drug: SC VK3019","Drug: Matching placebo",{"label":37,"type":31,"description":32,"interventionNames":38},"VK3019 Dose Level 2",[34,35],{"label":40,"type":31,"description":32,"interventionNames":41},"VK3019 Dose Level 3",[34,35],{"label":43,"type":31,"description":32,"interventionNames":44},"VK3019 Dose Level 4",[34,35],{"label":46,"type":31,"description":32,"interventionNames":47},"VK3019 Dose Level 5",[34,35],{"label":49,"type":31,"description":32,"interventionNames":50},"VK 3019 Dose Level 6",[34,35],{"label":52,"type":31,"description":32,"interventionNames":53},"VK3019 Dose Level 7",[34,35],[55,60],{"type":56,"name":57,"description":58,"armGroupLabels":59,"otherNames":17},"DRUG","SC VK3019","Single dose VK3019",[49,30,37,40,43,46,52],{"type":56,"name":61,"description":62,"armGroupLabels":63,"otherNames":17},"Matching placebo","Single dose matching placebo",[49,30,37,40,43,46,52],[65],{"name":66,"role":67,"phone":68,"phoneExt":17,"email":69},"Hubert C Chen, MD","CONTACT","8587044660","clinicaltrials@vikingtherapeutics.com",[71],{"facility":72,"status":73,"city":74,"state":75,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":17},"Viking Clinical Site #001","RECRUITING","Lake Forest","California","92630","United States","US",{"type":80,"coordinates":81},"Point",[82,83],-117.68922,33.64697,{"lat":83,"lon":82},{"type":86,"investigatorFullName":17,"investigatorTitle":17,"investigatorAffiliation":17,"oldNameTitle":17,"oldOrganization":17},"SPONSOR","100658016","phase-1-a-phase-1-study-of-vk3019-in-overweight-and-obese-adults-without-comorbidities-100658016",false,"NCT07846033","A Phase 1 Study of VK3019 in Overweight and Obese Adults Without Comorbidities","A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of VK3019, an Amylin and Calcitonin Receptor Agonist, in Overweight and Obese Adults Without Comorbidities","Inclusion Criteria:\n\n* Must be capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF).\n* Participants must be medically healthy, with no significant medical history, have no clinically significant abnormalities on physical examination at Screening and\u002For before administration of the initial dose of IP in the opinion of the Investigator.\n* Body mass index ≥ 27 kg\u002Fm2 and \\\u003C 40 kg\u002Fm2.\n* Willing to comply with contraceptive requirements.\n\nExclusion Criteria:\n\n* Participants with any level of disease or organ system dysfunction as identified during physical examination, medical history or laboratory testing, as assessed by the Investigator.\n* Any surgical or medical condition (active or chronic) that may interfere with IP distribution, metabolism, excretion, or drug absorption.\n* History or presence of clinically significant acute or unstable cerebrovascular (stroke), hepatic, renal, gastrointestinal, pulmonary, immunological, endocrine, diabetes, hematological, oncological, or central nervous disorder that in the opinion of the Investigator would pose a significant risk for the participant.\n* Current or prior diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes).\n* History of, or current, clinically significant liver disease, gallbladder disease (with the exception of Gilbert's Syndrome), as assessed by the Investigator.\n* History of drug or alcohol abuse (ie, \\>14 drinks\u002Fweek for women or 21 drinks\u002Fweek for men \\[1 drink = 150 mL of wine or 360 mL of beer or 45 mL of hard liquor\\]) within 12 months of Screening.","ALL","18 Years","60 Years",{"count":98,"type":99},56,"ESTIMATED","INTERVENTIONAL",[102],"PHASE1","This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD) study to evaluate the safety, tolerability, pharmacodynamics and pharmacokinetics of VK3019 in overweight and obese adults without comorbidities.",[105],"Obese Adults",[107],"Weight loss","2026-09-22",{"date":110,"type":111},"2026-09-29","ACTUAL",{"date":113,"type":111},"2026-07-06",{"date":115,"type":99},"2026-11",{"name":5,"class":6},1]