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Tests treatment safety and results for Obesity
Official title Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Paraguay.
ClinicalTrials.gov ID: NCT07588438
What this study is testing
What is Tirzepatide (LIPOLESS de Laboratorio de Productos Eticos C.E.I.S.A.)?
Tirzepatide (LIPOLESS de Laboratorio de Productos Eticos C.E.I.S.A.) is an investigational medicine, given as an once-weekly injection under the skin, being studied as a potential treatment for obesity.
Also referred to as Dual GIP/GLP-1 Receptor Agonist.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a prospective cohort study evaluating the efficacy, safety, and tolerability of tirzepatide under real-world conditions in the Paraguayan population. The study includes two cohorts: Cohort 1 consists of adults with obesity (BMI ≥30 kg/m²) without type 2 diabetes mellitus (T2DM), and Cohort 2 consists of adults with T2DM with or without obesity.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- 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.
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Asunción, Paraguay
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Asunción, Paraguay. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.