An observational study in Obesity, Type 2 Diabetes Mellitus and Overweight With Comorbidities, sponsored by LABORATORIOS INDUFAR. Not yet recruiting at 1 site in Paraguay. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-25.
Sponsored by LABORATORIOS INDUFAR · Observational
This is a Phase 4 observational study evaluating the safety and effectiveness of tirzepatide (T.G.) manufactured by INDUFAR S.A. in 300 patients with obesity treated at the Obesity Unit of Hospital de Clínicas in Paraguay over 12 months. The primary objective is to assess the safety profile through monitoring adverse events. Secondary objectives include evaluating weight loss, metabolic parameters improvement, and treatment satisfaction in real-world clinical practice.
This prospective, single-center, open-label, observational Phase 4 study will enroll 300 patients with obesity (BMI ≥27 kg/m² with comorbidities or BMI ≥35 kg/m²) with or without type 2 diabetes at the Obesity Unit of Hospital de Clínicas, Asunción, Paraguay.
Patients will receive tirzepatide subcutaneously once weekly following a dose-escalation schedule: 2.5 mg (weeks 1-4), 5 mg (weeks 5-8), with optional escalation to 7.5 mg, 10 mg, 12.5 mg, or 15 mg based on tolerability and response. The medication will be provided free of cost by the sponsor INDUFAR S.A.
The study includes 4 in-person visits (baseline, months 3, 6, 12) and 2 telephone contacts (months 1, 9). Assessments include physical examination, laboratory tests (HbA1c in diabetics, fasting glucose, lipid profile, renal and hepatic function), adverse event monitoring, and quality of life questionnaires.
Primary endpoint: Incidence, type, severity, and outcome of adverse events during 12 months, with special attention to serious adverse events and events of special interest (pancreatitis, severe hypersensitivity, severe hypoglycemia, biliary disease, acute kidney injury).
Secondary endpoints: Change in body weight and BMI, proportion achieving ≥5%, ≥10%, ≥15% weight loss, change in HbA1c (in diabetics), cardiometabolic parameters, treatment adherence, and patient satisfaction.
This study will generate the first evidence on tirzepatide in the Paraguayan population and support clinical decision-making regarding use of this dual GIP/GLP-1 receptor agonist in real-world obesity management.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 300 is above the median of 114 across 2,154 observational studies indexed under Obesity.
Browse Obesity studies →This is the only study on the registry with LABORATORIOS INDUFAR as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Patients who attend the Endocrinology Unit of Hospital de Clínicas, Universidad Nacional de Asunción, Paraguay
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All enrolled patients receiving tirzepatide according to clinical indication
Drug: Tirzepatide (T.G.)
Subcutaneous injection once weekly Dose escalation: 2.5 mg → 5 mg → 7.5 mg → 10 mg → 12.5 mg → 15 mg Duration: 12 months
Incidence of Adverse Events
Frequency, type, severity, causality, and outcome of adverse events Special focus on serious adverse events and events of special interest.
Time frame: 12 months
Change in Body Weight
Description: Mean change in body weight from baseline Unit of measure: Kilograms (kg)
Time frame: 12 months
Change in body mass index (BMI)
Description: Mean change in BMI calculated as weight(kg)/height(m)² Unit of measure: kg/m²
Time frame: 12 months
Change in systolic and diastolic blood pressure
Description: Mean change in systolic and diastolic blood pressure measured with calibrated digital sphygmomanometer Unit of measure: mmHg
Time frame: 12 months
Change in total cholesterol, HDL cholesterol, tryglicerides
Description: Mean change in serum total cholesterol levels using enzymatic method Unit of measure: mg/dL
Time frame: 12 months
Reasons for treatment discontinuation
Description: Classification of reasons for treatment discontinuation (adverse events, lack of efficacy, patient decision, others) Unit of measure: Number and percentage by category
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Mar 2026; primary completion for Oct 2026, 7 months later.
Of 45 industry-sponsored observational studies under Obesity, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 45. This study's planned 7 months is below that.
Counting every sponsor, half of 836 studies reached it within 39 months; a quarter within 17 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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