[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100179789":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":11,"centralContacts":11,"locations":11,"responsibleParty":41,"collaborators":11,"id":43,"slug":44,"hasResults":45,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":11,"eligibilityCriteria":49,"healthyVolunteers":50,"sex":51,"minAge":52,"maxAge":53,"enrollmentInfo":54,"targetDuration":11,"studyType":57,"phases":58,"briefSummary":60,"conditions":61,"keywords":11,"overallStatus":63,"whyStopped":11,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":11},{"fullName":5,"class":6},"Merck Sharp & Dohme LLC","INDUSTRY",[8,15,18,21,24,27],{"label":9,"type":10,"description":11,"interventionNames":12},"0.35 mg MK-5823 - Healthy Participants","EXPERIMENTAL",null,[13,14],"Drug: MK-5823","Other: Placebo",{"label":16,"type":10,"description":11,"interventionNames":17},"0.7 mg MK-5823 - Healthy Participants",[13,14],{"label":19,"type":10,"description":11,"interventionNames":20},"1.4 mg MK-5823 - Healthy Participants",[13,14],{"label":22,"type":10,"description":11,"interventionNames":23},"2.8 mg MK-5823 - Healthy Participants",[13,14],{"label":25,"type":10,"description":11,"interventionNames":26},"1.4 mg MK-5823 - Participants with T2DM",[13,14],{"label":28,"type":10,"description":11,"interventionNames":29},"2.8 mg MK-5823 - Participants with T2DM",[13,14],[31,36],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":11},"DRUG","MK-5823","MK-5823 administered subcutaneously (doses ranging from 0.35 mg to 2.8 mg) once daily for 3 weeks. Doses may be adjusted downward based on safety, tolerability, and\u002For pharmacokinetic data. The decision to dose escalate will be based on accrued safety\u002Ftolerability data at the prior dose level.\n\nIn each arm, 6 participants will be randomized to receive study drug and 2 participants will be randomized to receive placebo.",[9,16,19,25,22,28],{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":11},"OTHER","Placebo","Matching placebo to MK-5823 administered subcutaneously once daily for 3 weeks.",[9,16,19,25,22,28],{"type":42,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100179789","phase-1-a-study-of-the-safety-tolerability-pharmacokinetics-and-pharmacodynamics-of-mk-5823-in-overweight-or-obese-participants-who-are-healthy-or-have-type-2-diabetes-mellitus-mk-5823-002-100179789",false,"NCT01614782","A Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-5823 in Overweight or Obese Participants Who Are Healthy or Have Type 2 Diabetes Mellitus (MK-5823-002)","A Multiple Dose Clinical Trial to Study the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of MK-5823 in Healthy Overweight\u002FObese Subjects and Patients With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Male or female of non-childbearing potential\n* A Body Mass Index between 27 and 35 kg\u002Fm\\^2 and weighs at least 50 kg\n* Judged to be in good health and for the T2DM Panels, good health other than the diagnosis of T2DM\n* For T2DM Panels only: has a diagnosis of T2DM and is being treated with lifestyle management (e.g. diet and exercise) alone or in combination with a stable dose of metformin\n* A nonsmoker and\u002For has not used nicotine or nicotine-containing products for at least approximately 6 months\n\nExclusion Criteria:\n\n* History of stroke, chronic seizures or major neurological disorder\n* History of clinically significant gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases.\n* History of clinically significant endocrine abnormalities or diseases (including type I or type II, or steroid-induced diabetes for healthy participant panel; and excluding T2DM for the T2DM Panels)\n* Irritable bowel syndrome, or recurrent nausea, vomiting, diarrhea, or abdominal pain.\n* History of neoplastic disease\n* History of cataracts, diabetic retinopathy, macular edema, macular degeneration, vitreous hemorrhage, glaucoma, ocular surgery, ocular trauma or blindness\n* Requires treatment with systemic or ocular corticosteroids\n* For T2DM Panels, a history of hypoglycemic unawareness\n* For T2DM Panels, active treatment with any anti-hyperglycemic drug other than metformin\n* For T2DM Panels, treatment with any peroxisome proliferator-activated receptor-gamma agonist (e.g. Avandia or Actos) within 12 weeks of study participation\n* Unable to refrain from using any medication beginning 2 weeks before study participation\n* Consumes excessive amounts of alcohol (\\>3 per day)\n* Consumes more than 6 caffeinated beverages per day\n* Had major surgery or donated or lost more than 1 unit of blood\n* Participated in another investigational study within 4 weeks of study participation\n* History of significant multiple and\u002For severe allergies or anaphylactic reaction\n* Hypersensitivity to glucagon or insulin\n* Uses illicit drugs or has a history of drug or alcohol abuse within 3 months of study participation\n* Woman of child-bearing potential or is a nursing mother\n* For T2DM Panels, age \\>50 years",true,"ALL","18 Years","65 Years",{"count":55,"type":56},24,"ACTUAL","INTERVENTIONAL",[59],"PHASE1","The purpose of this study is to assess the multiple rising dose safety\u002Ftolerability and pharmacokinetics of MK-5823 in overweight\u002Fobese participants who are healthy and overweight\u002Fobese participants with Type 2 diabetes mellitus (T2DM).",[62],"Type 2 Diabetes Mellitus","TERMINATED","2016-02-03",{"date":66,"type":67},"2016-02-05","ESTIMATED",{"date":69,"type":11},"2012-06",{"date":71,"type":56},"2012-10",{"name":5,"class":6}]