[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100053438":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":35,"centralContacts":40,"locations":49,"responsibleParty":69,"collaborators":26,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":26,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":81,"enrollmentInfo":82,"targetDuration":26,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":92,"overallStatus":94,"whyStopped":26,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"National Institutes of Health Clinical Center (CC)","NIH",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"ALA then placebo","EXPERIMENTAL","Participants receive 50mg\u002Fday MG and 2.4g\u002Fday ALA (taken in two doses, once in the morning and once in the evening). Then, after a 4-26 week washout period, participants receive 50mg\u002Fday MG and twice a day (morning and evening) placebo.",[13,14,15],"Drug: Alpha-lipoic acid","Drug: Mirabegron","Drug: Placebo",{"label":17,"type":10,"description":18,"interventionNames":19},"Placebo then ALA","Participants receive 50mg\u002Fday MG and twice a day (morning and evening) placebo. Then, after a 4-26 week washout period, participants receive 50mg\u002Fday MG and 2.4g\u002Fday ALA (taken in two doses, once in the morning and once in the evening).",[13,14,15],[21,27,31],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Alpha-lipoic acid","ALA (2.4g) is in a capsule taken twice per day, once in the morning and once in the evening.",[9,17],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Mirabegron","Mirabegron (50mg) is a yellow pill taken once per day in the morning.",[9,17],{"type":22,"name":32,"description":33,"armGroupLabels":34,"otherNames":26},"Placebo","Placebo will be visibly similar to ALA capsules. They are off-white, clear vegetable-based capsules containing an inert microcrystalline cellulose powder.",[9,17],[36],{"name":37,"affiliation":38,"role":39},"Aaron M Cypess, M.D.","National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","PRINCIPAL_INVESTIGATOR",[41,46],{"name":42,"role":43,"phone":44,"phoneExt":26,"email":45},"Ashley M Schmitz, C.R.N.P.","CONTACT","(920) 948-1186","ashley.schmitz@nih.gov",{"name":37,"role":43,"phone":47,"phoneExt":26,"email":48},"(301) 435-9267","aaron.cypess@nih.gov",[50],{"facility":51,"status":26,"city":52,"state":53,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"National Institutes of Health Clinical Center","Bethesda","Maryland","20892","United States","US",{"type":58,"coordinates":59},"Point",[60,61],-77.10026,38.98067,{"lat":61,"lon":60},[64],{"name":65,"role":43,"phone":66,"phoneExt":67,"email":68},"NIH Clinical Center Office of Patient Recruitment (OPR)","800-411-1222","TTY dial 711","ccopr@nih.gov",{"type":70,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100053438","phase-2-trial-of-the-combination-of-alpha-lipoic-acid-and-mirabegron-in-women-and-in-men-with-obesity-100053438",false,"NCT05713799","Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity","Phase II Trial of the Combination of Alpha-lipoic Acid and Mirabegron in Women and in Men With Obesity","* INCLUSION CRITERIA\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Adults 18 to 65 years of age\n2. BMI greater than or equal to 30 kg\u002Fm\\^2 and less than or equal to 45 kg\u002Fm\\^2\n\nEXCLUSION CRITERIA\n\nAn individual who meets any of the following criteria will be excluded from participation in this study:\n\n1. Hypersensitivity and associated allergic reactions to mirabegron or alpha-lipoic acid (or similar drug substances or components).\n2. Abnormal bladder function, diagnosis of bladder outlet obstruction, urgency, and urinary frequency or use of antimuscarinic medication to treat overactive bladder (OAB).\n3. Type 1 diabetes mellitus; type 2 diabetes mellitus; or any person taking exogenous insulin therapy or any medication that is a hypoglycemic agent. (type 1 or Type 2 Diabetes mellitus, fasting serum glucose \\>125 mg\u002FdL, and\u002For an HbA1c test \\>6.5%).\n4. Elevated resting blood pressure \\>140\u002F90 mmHg.\n5. Individuals with eGFR \\\u003C60 ml\u002Fmin\u002F1.72 m\\^2 and a urinary albumin\u002Fcreatinine ratio UACR\\>300 mg\u002Fg.\n6. Hypo- or hyper-thyroid disease (TSH \\>5.0, or \\\u003C0.4 MIU\u002FL) that is controlled for less than one year or someone currently taking thyroid hormone replacement.\n7. Anemia, defined by hemoglobin \\\u003C11.5 g\u002FdL (females) or \\\u003C13.5 g\u002FdL (males); sickle cell anemia or other blood disorders; and\u002For wound healing problems.\n8. Cardiovascular disease, cardiac arrhythmias, orthostasis, unstable vasomotor system, or renal impairment.\n9. A clinically significant abnormal ECG and\u002For QTc interval above normal\n10. Moderate hepatic impairment (Child-Pugh Class B) or above\n11. Elevated liver enzymes \\>75 U\u002FL (ALT or AST)\n12. Recent history in last 4 weeks of any local or systemic infectious disease with fever or requiring antibiotics\n13. Pregnancy, childbirth within the last year, or breastfeeding in the past 12 months.\n14. Individuals that have been on a very low-calorie diet (\\\u003C800 kcal\u002Fd), self-reported weight loss \\>5% in the preceding six months, or those taking weight loss medications.\n15. History of seizure disorder.\n16. Addiction to alcohol or substances of abuse within the last 5 years.\n17. Self-reported current alcohol consumption of more than 2 servings of alcohol per day.\n18. Self-reported current use of nicotine and\u002For tobacco products.\n19. Current use of any drugs known to:\n\n    1. Have major drug-drug interactions with mirabegron or alpha-lipoic acid\n    2. Be CYP2D6 substrates\n    3. Prolong QT interval\n    4. Alter glucose metabolism or cause insulin resistance (in last six months)\n    5. Treat diabetes mellitus\n    6. Treat hypertension\n    7. Be drugs of abuse\n20. Inability to provide informed consent.\n21. Unwilling or unable to eat metabolic meals, as determined by dietitian consult.\n22. Individuals with significant medical comorbidities or other factors that would render the individual s participation unsafe or affect the outcome of the study as assessed by the investigator.",true,"ALL","18 Years","65 Years",{"count":83,"type":84},60,"ESTIMATED","INTERVENTIONAL",[87],"PHASE2","Background:\n\nObesity and related illnesses cause at least 2.8 million deaths each year worldwide. Few treatments exist for obesity that are safe and widely available. A study drug (mirabegron \\[MG\\]) combined with a supplement (alpha-lipoic acid \\[ALA\\]) may help.\n\nObjective:\n\nTo learn how MG and ALA can help the body process food.\n\nEligibility:\n\nPeople aged 18 to 65 years with a body mass index between 30 and 45 kg\u002Fm2.\n\nDesign:\n\nParticipants will be screened. They will have a physical exam. They will have blood and urine tests and a test of their heart function. They will speak with a dietician.\n\nThe study has two phases. Each phase begins with a 2-day stay in the clinic; then the participant will take the study drugs at home for about 4 weeks, followed by another 2-day stay in the clinic. They will also have outpatient visits about 2 weeks after each clinic stay.\n\nDuring the clinic stays, participants will undergo many tests:\n\nThey will have a plastic tube (catheter) inserted into a vein in each arm. These will be used to draw blood and to infuse glucose (sugar) and insulin.\n\nThey will have imaging scans.\n\nThey will have a clear hard plastic shield placed over their head to measure oxygen and carbon dioxide as they breathe.\n\nParticipants will take the study drugs at home. Both MG and ALA are taken by mouth with water. During one phase, participants will take MG plus a placebo. A placebo looks like the study drug but doesn t contain medicine....",[90,91],"Insulin Resistance","Obesity",[91,93,90,32],"Insulin Sensitivity","NOT_YET_RECRUITING","2026-07-10",{"date":97,"type":98},"2026-07-13","ACTUAL",{"date":100,"type":84},"2026-07-16",{"date":102,"type":84},"2030-03-01",{"name":38,"class":6},1]