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Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Paraguay.

NCT07588438 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2026-05-19

No results posted yet for this study

Summary

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. Each cohort will enroll 80 participants (160 total). All participants will receive tirzepatide as part of their standard clinical care and will be followed for 52 weeks with visits approximately every 6 weeks. Primary outcomes include percentage change in body weight from baseline at week 52 (Cohort 1) and change in HbA1c and body weight at week 52 (Cohort 2). Safety outcomes include adverse event rates. The study is conducted at Las Rias Medical Center, Asuncion, Paraguay, and has been approved by the CEI-INCAN Ethics Committee and authorized by DINAVISA.

Conditions

  • Obesity
  • Diabetes Mellitus, Type 2

Interventions

DRUG

Tirzepatide (LIPOLESS de Laboratorio de Productos Eticos C.E.I.S.A.)

Participants will receive subcutaneous injections of tirzepatide (LIPOLESS de Laboratorio de Productos Eticos C.E.I.S.A.) once weekly. The dosage will be adjusted according to standard clinical practice and the investigator's discretion, following the manufacturer's titration schedule (starting at 2.5 mg and increasing up to 15 mg as tolerated).

Sponsors & Collaborators

  • LABORATORIO DE PRODUCTOS ETICOS C.E.I.S.A

    collaborator UNKNOWN

  • Las Rías Medical Center

    lead OTHER

Principal Investigators

  • ELIZABETH VALINOTTI DELMAS, MD · LAS RIAS MEDICAL CENTER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-27
Primary Completion
2027-08-10
Completion
2027-08-10

Countries

  • Paraguay

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07588438 on ClinicalTrials.gov