Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Paraguay.
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLas Rías Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age between 18 and 70 years at the time of informed consent.
Stable residence in Paraguay for at least 12 months prior to screening.
Ability to provide written informed consent and comply with all study procedures.
Sufficient proficiency in the Spanish language to complete questionnaires and follow study instructions.
Disqualifiers
Diagnosis of type 1 diabetes mellitus or secondary causes of diabetes.
History of diabetic ketoacidosis within 12 months prior to screening.
Current or recent use (within 3 months prior to screening) of GLP-1 receptor agonists or dual GIP/GLP-1 receptor agonists.
Current or prior use of insulin therapy for the management of diabetes.
Trial design
Design model
Single group
Treatments tested in this trial
Tirzepatide (LIPOLESS de Laboratorio de Productos Eticos C.E.I.S.A.)
DrugParticipants 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).
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Cohort 1: Obesity Without T2DMExperimental treatment 1 intervention
Group B: Cohort 2: T2DM With or Without ObesityExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mean Percent Change From Baseline in Body Weight at 52 Weeks.
Percentage change in total body weight from baseline to week 52 for participants in Cohort A (Adults with obesity without diabetes).
Time frame
Baseline and 52 weeks.2
Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at 52 Weeks.
Absolute change in HbA1c levels from baseline to week 52 for participants in Cohort B (Adults with type 2 diabetes).
Time frame
Baseline and 52 weeks.3
Number of Participants With Treatment-Emergent Adverse Events (TEAEs).
Incidence, severity, and relationship of treatment-emergent adverse events (TEAEs), including gastrointestinal, pancreatic, cardiovascular, and other adverse events occurring during the 52-week treatment period.
Time frame
Through week 52.Secondary outcomes
1
Mean Change From Baseline in Body Weight at 52 Weeks.
Change in absolute body weight from baseline to week 52.
Time frame
Baseline and 52 weeks.2
Mean Change From Baseline in Body Mass Index (BMI) at 52 Weeks.
Change in BMI calculated as weight in kilograms divided by height in meters squared (kg/m2).
Time frame
Baseline and 52 weeks.3
Percentage of Participants Achieving Body Weight Reduction Thresholds at 52 Weeks.
Percentage of participants achieving ≥5%, 10%, 15%, 20%, 25%, and 30% reduction from baseline body weight.
Time frame
52 weeks.4
Change From Baseline in Systolic Blood Pressure at 52 Weeks.
Assessment of the absolute change in resting systolic blood pressure.
Time frame
Baseline and 52 weeks.Other outcomes
1
Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at 52 Weeks.
Evaluation of renal function through changes in estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI equation from baseline to week 52.
Time frame
Baseline and 52 weeks.2
Mean Change From Baseline in Serum Cystatin C at 52 Weeks.
Evaluation of renal function through changes in serum Cystatin C concentrations from baseline to week 52.
Time frame
Baseline and 52 weeks.3
Mean Change From Baseline in Alanine Aminotransferase (ALT) Levels at 52 Weeks.
Assessment of liver function through the absolute change in serum alanine aminotransferase (ALT) concentrations from baseline to week 52.
Time frame
Baseline and 52 weeks.4
Mean Change From Baseline in Aspartate Aminotransferase (AST) Levels at 52 Weeks.
Assessment of liver function through the absolute change in serum aspartate aminotransferase (AST) concentrations from baseline to week 52.
Time frame
Baseline and 52 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Las Rías Medical Center
Lead sponsor
LABORATORIO DE PRODUCTOS ETICOS C.E.I.S.A
Collaborator
Source ClinicalTrials.gov