Obesity, Overweight With Comorbidities, Type 2 Diabetes Mellitus
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DRUGTirzepatide (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
Sponsors
LABORATORIOS INDUFAR
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 years * BMI ≥27 kg/m² with weight-related comorbidities OR BMI ≥35 kg/m² * Clinical indication for tirzepatide per treating physician * Paraguayan citizenship or permanent residence * Residence in Asunción or Metropolitan Area or possibility to assist to regular visits * Ability to attend visits for 12 months * Ability to provide written informed consent
Exclusion criteria
* Type 1 diabetes or secondary diabetes * Known hypersensitivity to tirzepatide * Personal or family history of medullary thyroid carcinoma or MEN 2 syndrome * Acute pancreatitis in last 12 months or chronic pancreatitis * Severe gastrointestinal disease * Bariatric surgery in last 12 months * Pregnancy or breastfeeding * Severe renal impairment (eGFR \<30 mL/min/1.73m²) * Severe hepatic impairment (Child-Pugh B or C) * Unstable cardiovascular disease * Active cancer (except non-melanoma skin cancer completely resected) * Current use of other GLP-1 receptor agonists * Participation in another interventional trial within 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Adverse Events | 12 months | Frequency, type, severity, causality, and outcome of adverse events Special focus on serious adverse events and events of special interest. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | 12 months | Description: Mean change in body weight from baseline Unit of measure: Kilograms (kg) |
| Change in body mass index (BMI) | 12 months | Description: Mean change in BMI calculated as weight(kg)/height(m)² Unit of measure: kg/m² |
| Change in systolic and diastolic blood pressure | 12 months | Description: Mean change in systolic and diastolic blood pressure measured with calibrated digital sphygmomanometer Unit of measure: mmHg |
| Change in total cholesterol, HDL cholesterol, tryglicerides | 12 months | Description: Mean change in serum total cholesterol levels using enzymatic method Unit of measure: mg/dL |
| Reasons for treatment discontinuation | 12 months | Description: Classification of reasons for treatment discontinuation (adverse events, lack of efficacy, patient decision, others) Unit of measure: Number and percentage by category |
Countries
Paraguay
Contacts
CONTACTAna Iris Ramirez, Msc
Outcome results
None listed