ELITE: Deep Profiling and Algorithmic Polytherapy to Map Individual Response in Healthy Aging

Who can take part

Inclusion Criteria: * Male or female, aged 50 to 80 years, inclusive. * Generally healthy, as determined by medical history and screening assessments, with no more than 2 stable, well-controlled chronic conditions. * Body-mass index (BMI) ≥25 kg/m². * No diagnosis of Type 1 or Type 2 diabetes mellitus and screening HbA1c \<6.5%. * Willing and able to provide written informed consent prior to any study-related procedures. * Willing and able to comply with all study procedures, including daily use of a compatible smartphone or tablet for app-based digital biomarker data collection and completion of required home study procedures. * If female and of childbearing potential, must be postmenopausal for at least one year. Exclusion Criteria: Metabolic \& Endocrine * Diagnosis of Type 1 or Type 2 diabetes mellitus, or HbA1c ≥6.5% at screening. * History of pancreatitis, medullary thyroid carcinoma (personal or family), or Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). * History of significant or recurrent hypoglycemia requiring medical intervention. * Known Child-Pugh Class B or C hepatic disease. * BMI \<25 kg/m². Renal \& Genitourinary * Impaired renal function, defined as an estimated glomerular filtration rate (eGFR) \<45 mL/min/1.73 m² at screening, or a reported renal problem. * History of diabetic ketoacidosis (DKA). * History of recurrent (≥3 in the last 12 months) or severe urinary tract infections or genital mycotic infections. Gastrointestinal * Self-reported history of severe gastrointestinal disease such as gastroparesis, inflammatory bowel disease (Crohn's disease or ulcerative colitis), or chronic malabsorption syndromes; known gallstones; significant hypertriglyceridemia (e.g., triglycerides \>500 mg/dL); or prior biliary tract surgery. * Previous bariatric surgery that may affect drug absorption (e.g., gastric bypass). Cardiovascular * New York Heart Association (NYHA) Class III or IV congestive heart failure. * History of myocardial infarction, unstable angina, or stroke within the 6 months prior to screening. * Symptomatic hypotension or a screening systolic blood pressure consistently \<100 mmHg. Other Medical Conditions * Active malignancy within the last 2 years, with the exception of successfully treated non-melanoma skin cancer or cervical carcinoma in situ. * Known significant active liver disease (e.g., active hepatitis or cirrhosis), or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.5 times the upper limit of normal at screening. * History of lactic acidosis. * Any condition associated with an increased risk of lactic acidosis, such as severe dehydration or acute systemic illness at the time of screening. * Current or recent (within 2 years) diagnosis of anorexia nervosa, bulimia, or another eating disorder. * Current use of known nephrotoxic agents (e.g., high-dose NSAIDs or contrast agents) that may exacerbate renal risk. Concomitant Medications \& Lifestyle * Current use of any other glucose-lowering agents (e.g., insulin, other GLP-1 receptor agonists, DPP-4 inhibitors, or sulfonylureas). * Chronic use of systemic corticosteroids or loop diuretics. Inhaled or topical corticosteroids and stable replacement doses (e.g., hydrocortisone \<20 mg/day) are acceptable. * Participation in another interventional clinical trial within the 3 months prior to screening. * Excessive alcohol consumption, defined as more than 14 standard drinks per week for men or 7 per week for women, or a history of alcohol use disorder. * Known allergy or hypersensitivity to metformin, semaglutide, any SGLT-2 inhibitor, or any of their components or excipients. General * Any condition which, in the opinion of the investigator, would place the participant at undue risk or interfere with the study's conduct or the interpretation of its results. * Cognitive or mental impairment that would prevent the participant from understanding the consent form, adhering to daily tasks, or providing reliable data.

Registry changes

No changes recorded since the trial was added.