Clinical Research Directory

Inclusion Criteria: * Age between 18 and 70 years at the time of informed consent. * Stable residence in Paraguay for at least 12 months prior to screening. * Ability to provide written informed consent and comply with all study procedures. * Sufficient proficiency in the Spanish language to complete questionnaires and follow study instructions. * Clinical stability, defined as the absence of hospitalization related to diabetes or obesity complications within 3 months prior to screening. * Adequate renal function, defined as an estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73m² calculated using the CKD-EPI equation. * For participants enrolled in the obesity cohort: clinical diagnosis of obesity with BMI ≥30 kg/m², no prior diagnosis of diabetes mellitus (HbA1c \<6.5%), and at least one documented unsuccessful attempt at dietary weight-loss intervention within the previous 12 months. * For participants enrolled in the type 2 diabetes mellitus (T2DM) cohort: established diagnosis of T2DM for at least 6 months prior to screening according to ADA 2025 criteria, HbA1c between 7.0% and 9.5% at screening confirmed at baseline, BMI ≥24 kg/m², and stable treatment on monotherapy or dual therapy with metformin, sulfonylureas, DPP-4 inhibitors, or SGLT-2 inhibitors for at least 3 months prior to screening. Exclusion Criteria: * Diagnosis of type 1 diabetes mellitus or secondary causes of diabetes. * History of diabetic ketoacidosis within 12 months prior to screening. * Current or recent use (within 3 months prior to screening) of GLP-1 receptor agonists or dual GIP/GLP-1 receptor agonists. * Current or prior use of insulin therapy for the management of diabetes. * Clinically significant untreated thyroid dysfunction, including hypothyroidism or hyperthyroidism. * Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2. * Major adverse cardiovascular event (MACE), including acute myocardial infarction, stroke, or hospitalization for heart failure within 6 months prior to screening. * Heart failure classified as New York Heart Association (NYHA) Functional Class III or IV. * Uncontrolled hypertension, defined as systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite optimal antihypertensive therapy. * History of acute or chronic pancreatitis. * Active inflammatory bowel disease or prior bariatric surgery. * Clinically significant diabetic gastroparesis or other gastrointestinal motility disorders that may interfere with the absorption of concomitant oral medications. * Use of systemic corticosteroids for more than 14 consecutive days within 3 months prior to screening. * Treatment with oral anti-obesity medications (including orlistat, phentermine, naltrexone/bupropion, or topiramate) within 3 months prior to screening. * Participation in another clinical trial involving an investigational medicinal product within 30 days prior to screening. * Moderate to advanced chronic kidney disease defined as eGFR \<45 mL/min/1.73m² or requirement for dialysis. * Active liver disease or transaminase levels (ALT/AST) greater than 3 times the upper limit of normal. * Active malignancy or history of cancer within the previous 5 years, except for completely resected basal cell or squamous cell skin carcinoma. * Uncontrolled major psychiatric disorders or history of suicide attempt within the previous 2 years. * Confirmed or suspected pregnancy, including positive serum beta-hCG test at screening, or active breastfeeding. * Intention to become pregnant during the study period. * Women of childbearing potential unwilling to use effective contraceptive methods (hormonal, intrauterine, or dual-barrier) throughout the study and for 3 months after the final dose.