[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659708":3},{"organization":4,"outcomesModule":7,"designInfo":14,"detailedDescription":23,"studyPopulation":13,"armGroups":24,"interventions":45,"overallOfficials":13,"centralContacts":55,"locations":13,"responsibleParty":61,"collaborators":13,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":13,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":13,"enrollmentInfo":72,"targetDuration":13,"studyType":75,"phases":76,"briefSummary":78,"conditions":79,"keywords":81,"overallStatus":84,"whyStopped":13,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":13},{"fullName":5,"class":6},"Viking Therapeutics, Inc.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":13},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage change in body weight for participants receiving VK2735 orally once daily","To demonstrate that VK2735 27.5mg, 35mg, and 55mg daily oral (each dose separately) is superior to placebo for percent change in body weight from baseline to week 68","68 weeks",null,{"allocation":15,"interventionModel":16,"interventionModelDescription":13,"primaryPurpose":17,"observationalModel":13,"timePerspective":13,"maskingInfo":18},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":19,"maskingDescription":13,"whoMasked":20},"DOUBLE",[21,22],"PARTICIPANT","INVESTIGATOR","This is a Phase 3, multicenter, 68-week randomized, double-blind, placebo-controlled, parallel arm study that will evaluate the safety, tolerability, weight loss efficacy, pharmacodynamic effects, and pharmacokinetics of VK2735 oral formulation in adults who are obese or overweight with one or more weight related comorbid conditions without Type 2 Diabetes Mellitus. Three VK2735 doses and matched placebo administered orally will be evaluated (Group 1 = Placebo; Group 2 = 27.5 mg; Group 3 = 35 mg; Group 4 = 55 mg). All participants in Treatment Groups 2 - 4 will initiate dosing at 10 mg, then increase dose to 17.5 mg at Week 4. The dose will be increased every 4 weeks for each treatment group until Treatment Group 2 reaches 27.5 mg at Week 8, Treatment Group 3 reaches 35 mg at Week 12 and Treatment Group 4 reaches 55 mg at Week 16.",[25,31,37,41],{"label":26,"type":27,"description":28,"interventionNames":29},"Placebo Assignment","PLACEBO_COMPARATOR","Placebo comparator orally once daily",[30],"Drug: Placebo comparator",{"label":32,"type":33,"description":34,"interventionNames":35},"Active Assignment (Dose 1)","EXPERIMENTAL","VK2735 27.5mg orally once daily",[36],"Drug: VK2735",{"label":38,"type":33,"description":39,"interventionNames":40},"Active Assignment (Dose 2)","VK2735 35mg orally once daily",[36],{"label":42,"type":33,"description":43,"interventionNames":44},"Active Assignment (Dose 3)","VK2735 55mg orally once daily",[36],[46,51],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":13},"DRUG","VK2735","VK2735 Oral is a peptide GLP-1 and GIP dual agonist administered once daily",[32,38,42],{"type":47,"name":52,"description":53,"armGroupLabels":54,"otherNames":13},"Placebo comparator","Placebo comparator administered orally once daily",[26],[56],{"name":57,"role":58,"phone":59,"phoneExt":13,"email":60},"Hubert Chen, MD","CONTACT","8587044660","clinicaltrials@vikingtherapeutics.com",{"type":62,"investigatorFullName":13,"investigatorTitle":13,"investigatorAffiliation":13,"oldNameTitle":13,"oldOrganization":13},"SPONSOR","100659708","phase-3-oral-vk2735-for-weight-management-phase-3-sunrise-1-100659708",false,"NCT07868835","Oral VK2735 for Weight Management Phase 3 (SUNRISE 1)","A Phase 3 Randomized, Double-Blind, Placebo-Controlled, 68-Week Efficacy and Safety Study of VK2735 Administered Orally for Weight Management in Participants Without Type 2 Diabetes Mellitus Who Are Obese, or Overweight With at Least One Weight-related Comorbid Condition","Inclusion Criteria:\n\n1. Age ≥18 years of age at the time of signing the informed consent.\n2. Body mass index (BMI) ≥30 kg\u002Fm2 OR ≥27 kg\u002Fm2 with at least one weight-related co-morbid condition (treated or untreated).\n\n   * Weight-related co-morbid conditions include hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease.\n   * Cardiovascular disease includes, for example, ischemic cardiovascular disease, NYHA Functional Class I-III heart failure.\n   * BMI calculated at the screening visit will be used to determine eligibility.\n\nExclusion Criteria:\n\n1. History of or current clinically significant medical disorder that, in the opinion of the Investigator, does not support study participation\n2. Self-reported body weight change of 5% or more within 3 months of screening\n3. Have a prior or planned surgical treatment for obesity such as a gastric sleeve, lap band or any form of bariatric surgery (excluding liposuction or abdominoplasty if performed \\>1 year prior to screening)\n4. Have or plan to have endoscopic and\u002For device-based therapy for obesity or have had device removal within the last 6 months prior to screening (such as mucosal ablation, gastric artery embolization, intragastric balloon, duodenal-jejunal endoluminal line)\n5. Current or past diagnosis of diabetes mellitus (including type 1, type 2, except gestational diabetes). If a participant has had gestational diabetes, they are allowed to be enrolled as long as the glycemic status has returned to normal levels after 12 months of completion of pregnancy\n6. Treatment with glucose-lowering agent(s) within 90 days before screening\n7. Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)\n8. History of acute or chronic pancreatitis","ALL","18 Years",{"count":73,"type":74},560,"ESTIMATED","INTERVENTIONAL",[77],"PHASE3","This study is one of two planned Phase 3 studies to support the weight management indication for VK2735 Oral in obese (BMI ≥ 30 kg\u002Fm2) or overweight (BMI ≥ 27kg\u002Fm2) adults with at least one weight-related comorbidity without type 2 diabetes mellitus.",[80],"Weight Loss",[82,83,80],"Body Weight Changes","Body Weight","NOT_YET_RECRUITING","2026-10-05",{"date":87,"type":88},"2026-10-09","ACTUAL",{"date":90,"type":74},"2026-10-15",{"date":92,"type":74},"2028-08",{"name":5,"class":6}]