Safety and Effectiveness of Tirzepatide in Patients With Obesity at Hospital de Clínicas, Paraguay

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Obesity; Type 2 Diabetes Mellitus; Overweight With Comorbidities
• Intervention / Treatment: Drug: Tirzepatide (T.G.)

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Ana Iris Ramirez, Msc; Phone Number: +595 981 873290; Email: anairisrabe@gmail.com

Study Locations

• Paraguay
  • Asunción, Paraguay
    • Endocrinology Unit, UNA, Py
    • Contact: Ana Iris Ramirez; Phone Number: +595 981 873290; Email: anairisrabe@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who attend the Endocrinology Unit of Hospital de Clínicas, Universidad Nacional de Asunción, Paraguay

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Tirzepatide Treatment Group; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Frequency, type, severity, causality, and outcome of adverse events Special focus on serious adverse events and events of special interest.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Body Weight	Description: Mean change in body weight from baseline Unit of measure: Kilograms (kg)	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	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	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	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	12 months

Collaborators and Investigators

• Sponsor: LABORATORIOS INDUFAR

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: December 12, 2025
• First Submitted That Met QC Criteria: March 19, 2026
• First Posted (Actual): March 25, 2026

Study Record Updates

• Last Update Posted (Actual): March 25, 2026
• Last Update Submitted That Met QC Criteria: March 19, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Nutrition Disorders; Metabolic Diseases; Overnutrition; Body Weight; Glucose Metabolism Disorders; Diabetes Mellitus; Overweight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity; Diabetes Mellitus, Type 2; Amino Acids, Peptides, and Proteins; Proteins; Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide; Tirzepatide
• Other Study ID Numbers: TG-PY-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No