[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650923":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":11,"centralContacts":33,"locations":11,"responsibleParty":38,"collaborators":11,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":11,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":11,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":11,"overallStatus":59,"whyStopped":11,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":11},{"fullName":5,"class":6},"Lumos Pharma","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"LUM-201 plus Semaglutide","EXPERIMENTAL",null,[13,14],"Drug: LUM-201","Drug: Semagludtide",{"label":16,"type":17,"description":11,"interventionNames":18},"Semaglutide plus placebo","PLACEBO_COMPARATOR",[19,14],"Drug: Placebo",[21,26,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":11},"DRUG","LUM-201","Daily (AM) oral Tablet at 25 mg",[9],{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":11},"Placebo","Daily (AM) oral Tablet",[16],{"type":22,"name":31,"description":28,"armGroupLabels":32,"otherNames":11},"Semagludtide",[9,16],[34],{"name":5,"role":35,"phone":36,"phoneExt":11,"email":37},"CONTACT","515-296-5555","clinical.trials@lumos-pharma.com",{"type":39,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100650923","evaluating-the-efficacy-and-safety-of-lum-201-plus-semaglutide-versus-semaglutide-plus-placebo-in-older-obese-adults-100650923",false,"NCT07754045","Evaluating the Efficacy and Safety of LUM-201 Plus Semaglutide Versus Semaglutide Plus Placebo in Older Obese Adults","Phase 2 Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study Evaluating the Efficacy and Safety of Oral LUM-201 as an Adjunct to Oral Semaglutide for Improving Physical Function in Older Adults With Obesity","Inclusion Criteria:\n\n* Be willing to provide written informed consent to participate in this study.\n* Males or females, aged ≥ 60 to \\\u003C 85 years.\n* Have a BMI ≥ 30 kg\u002Fm2.\n* SPPB score at the screening visit ≥ 7 to ≤ 9.\n* Have a history of ≥ 1 self-reported unsuccessful dietary effort to lose weight.\n* Female participants must be postmenopausal, confirmed by an follicle stimulating hormone (FSH) level ≥ 25 IU\u002FL.\n* Male participants must be able to comply with contraception requirements.\n* Must agree to refrain from any reconstructive and\u002For cosmetic surgery and\u002For non-invasive cosmetic procedure that may affect body weight during the study such as mammoplasty, lipoplasty, non-invasive adipose and\u002For cellulite treatment devices.\n* Must refrain from scheduling any elective surgery and\u002For other invasive or non-invasive procedures during the study unless medically warranted.\n\nExclusion Criteria:\n\n* Have Type 1 diabetes mellitus (T1DM) or Type 2 diabetes mellitus (T2DM).\n* Have laboratory evidence diagnostic of diabetes mellitus during screening.\n* Have history of diabetic ketoacidosis or hyperosmolar state\u002Fcoma within 6 months prior to screening.\n* Have a history of severe hypoglycemia.\n* Have a BMI \\> 45 kg\u002Fm2 or weight \\> 159 kg (350 lbs.).\n* Have a self-reported change in body weight \\> 5 kg (11 lbs.) within 3 months prior to screening.\n* Have received prior exposure to a GLP-1 receptor agonist (including dual GLP-1\u002F GIP receptor agonists\\]) within 180 days before screening, any other anti-obesity medication, glucose-lowering agent (non-GLP-1), or glucose lowering supplements such as berberine, etc. within 90 days before screening.\n* Have any other condition not listed in this section (for example, hypersensitivity or intolerance) that is a contraindication to GLP-1 receptor agonist or dual GLP-1\u002FGIP receptor agonist.\n* Have serum calcitonin concentration \\> 35 pg\u002FmL at screening.\n* Have a history of prior or planned surgical treatment for obesity.\n* Have uncontrolled hypertension with systolic blood pressure (SBP) ≥ 150 mm Hg and\u002For diastolic blood pressure (DBP) ≥ 95 mm Hg.\n* Mean QTcF (Fridericia \\[QTcF=QT\u002FRR1\u002F3\\]) interval \\> 450 ms (male) or \\> 470 ms (female) on triplicate ECGs.\n* Have fasting triglyceride \\> 500 mg\u002FdL.\n* Have any of the following within last 6 months prior to screening: NYHA Functional Classification I-IV heart failure, myocardial infarction, angina, coronary artery bypass graft, percutaneous coronary intervention, transient ischemic attack, stroke, or decompensated congestive heart failure.\n* Have an estimated glomerular filtration rate (eGFR) \\\u003C 60 mL\u002Fmin\u002F1.73 m2.\n* Have a known clinically significant gastric emptying abnormality.\n* Have a history of chronic or acute pancreatitis, or severe gastroesophageal reflux disease and symptomatic cholelithiasis with intact gallbladder.\n* Have serum lipase and\u002For amylase above 1.5 × the upper limit of normal (ULN).\n* Have a history of hepatic disorders including cirrhosis or other hepatic disorder other than metabolic-associated fatty liver disease (MAFLD), or nonalcoholic fatty liver disease.\n* Have active hepatitis B or C virus at screening. Have known positive history of human immunodeficiency virus. Have an active Coronavirus Disease 2019 at screening.\n* Have an impaired liver function, defined as screening aspartate aminotransferase (AST) \\> 2.5 × ULN, or alanine aminotransferase \\> 2.5 × ULN, or total bilirubin level \\> 1.2 × ULN (except for cases of known Gilbert's Syndrome).\n* Alkaline phosphatase (ALP) level \\> 1.5 × ULN.\n* Have untreated or uncontrolled hypothyroidism or hyperthyroidism.\n* Have obesity induced by other endocrinologic disorders.\n* Have a history of significant active or unstable Major Depressive Disorder (MDD) or other severe psychiatric disorder within the last 2 years.\n* Have any lifetime history of a suicide attempt.\n* Have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2.\n* Have a history of an active or untreated malignancy or are in remission from a clinically significant malignancy (other than basal- or squamous-cell skin cancer, in situ carcinomas of the cervix, or in situ prostate cancer) within the past 5 years prior to screening.\n* Have had a transplanted organ (corneal transplants \\[keratoplasty\\] allowed) or awaiting an organ transplant.\n* Have any hematological condition that may interfere with HbA1c measurement (for example, hemolytic anemias, sickle cell disease).\n* Are receiving or have received within 3 months prior to screening chronic (\\> 2 weeks or 14 days) systemic glucocorticoid therapy or have evidence of a significant active autoimmune abnormality that has required treatment within the last 3 months.\n* Have current or recent treatment with medications and\u002For supplements that may cause significant weight gain.\n* Currently receiving or planning to initiate during the study any muscle toning or body contouring treatments such as high-intensity focused electromagnetic therapy, or neurotoxin injections targeting large muscle groups (for example, trapezius, gastrocnemius) for slimming or relaxation purposes.\n* Have taken within 3 months prior to randomization, medications (prescribed or over-the counter) or alternative remedies intended to promote weight loss.\n* Have started implantable or injectable contraceptives (such as Depo-Provera®) within 6 months prior to screening.\n* Documented moderate to severe obstructive sleep apnea (unless controlled by medically prescribed intervention for at least 3 months prior to screening).\n* Prior treatment with growth factors including, but not limited to, GH, IGF-1, and GH secretagogues.","ALL","60 Years","84 Years",{"count":51,"type":52},202,"ESTIMATED","INTERVENTIONAL",[55],"PHASE2","This is a phase 2 randomized, double-blind, placebo-controlled, multi-center study evaluating the efficacy and safety of LUM-201 plus Semaglutide versus Semaglutide plus placebo in obese adults with body mass index between 30 and 45 kg\u002Fm\\^2, between the ages of 60 and 85 years that have mild functional impairment.",[58],"Obesity & Overweight","NOT_YET_RECRUITING","2026-08-06",{"date":62,"type":63},"2026-08-10","ACTUAL",{"date":65,"type":52},"2027-02-15",{"date":67,"type":52},"2028-02-15",{"name":5,"class":6}]