ObesityNCT07492563
Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay
An observational study of Obesity and Type 2 Diabetes Mellitus, run by LABORATORIOS INDUFAR at 1 site in Paraguay.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity, Type 2 Diabetes Mellitus, Overweight With Comorbidities
- What is being tested?
- Tirzepatide (T.G.)
- Type of treatment
- Injection or infusion
- How many people
- 300 participants
- Where
- 1 siteParaguay
- Study dates
- Mar 2026to Oct 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who attend the Endocrinology Unit of Hospital de Clínicas, Universidad Nacional de Asunción, Paraguay
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Paraguay1 site
Endocrinology Unit, UNA, Py
Asunción
Ana Iris Ramirez, +595 981 873290, anairisrabe@gmail.com
About this study
Official title: Effectiveness and Safety of Tirzepatide (t.g.) in Patients Treated at the Obesity Unit of the Department of Endocrinology of the Hospital de Clínicas, Faculty of Medical Sciences, UNA: Phase 4 Study
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.
Read the 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.
- Being tested
- Tirzepatide (T.G.)
- Medical subject headings
- Obesity, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tirzepatide (T.G.)Drug
Subcutaneous injection once weekly Dose escalation: 2.5 mg → 5 mg → 7.5 mg → 10 mg → 12.5 mg → 15 mg Duration: 12 months
| Study group | Role | What they receive |
|---|---|---|
| Tirzepatide Treatment Group | All enrolled patients receiving tirzepatide according to clinical indication Receives: Drug: Tirzepatide (T.G.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Frequency, type, severity, causality, and outcome of adverse events Special focus on serious adverse events and events of special interest.
Measured: 12 months
Secondary outcomes (5)
Change in Body Weight
Description: Mean change in body weight from baseline Unit of measure: Kilograms (kg)
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study startMar 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- LABORATORIOS INDUFAR
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Ana Iris Ramirez, Universidad Nacional de Asunción
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07492563
- Sponsor's protocol ID
- TG-PY-001
- Status last verified
- Mar 2026
- First submitted
- 12 Dec 2025
- Last updated
- 25 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided