Tirzepatide in real-world Paraguay for obesity and type 2 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a 52-week, prospective cohort study conducted at Las Rías Medical Center in Asunción, Paraguay, evaluating tirzepatide in two groups: adults with obesity but no diabetes, and adults with type 2 diabetes with or without obesity. Participants receive weekly subcutaneous tirzepatide as part of standard care and are followed with visits roughly every six weeks. The primary outcomes are percent weight change at 52 weeks in the obesity cohort and changes in HbA1c and body weight at 52 weeks in the diabetes cohort; safety outcomes include adverse events. The study aims to provide real-world evidence on efficacy, safety, and tolerability of dual GIP/GLP-1 receptor agonism in a regional population and to understand how regional factors influence treatment performance.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centro Médico Las Rias
  Asunción, Paraguay Recruiting

Study contacts

• Principal investigator: Elizabeth Valinotti Delmas, Md — Las Rias Medical Center
• Study coordinator: Elizabeth Valinotti Delmas, Md
• Email: elizabeth.valinotti@lasrias.com.py
• Phone: +595 981 312 888

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.