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

NCT07588438 | Recruiting Phase 4 DMC

• 1 other identifier: Eticos 01/25 V 1.1 03/12/2025
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tirzepatide; GIP Receptor Agonist; GLP-1 Receptor Agonist; Incretin-based Therapy; Dual Agonist; Obesity; Overweight; Type 2 Diabetes Mellitus; Metabolic Syndrome; Weight Loss; Real-World Evidence (RWE); Real-World Data; Prospective Cohort Study; Post-Marketing Surveillance; Observational Study; Paraguay; Latin America; South American Population; Body Composition; HbA1c Reduction; Adverse Events Monitoring

Outcome Measures

Primary Outcomes (3)

• 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).

  Baseline and 52 weeks.

• 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).

  Baseline and 52 weeks.

• 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.

  Through week 52.

Secondary Outcomes (18)

• Mean Change From Baseline in Body Weight at 52 Weeks.

  Baseline and 52 weeks.

• Mean Change From Baseline in Body Mass Index (BMI) at 52 Weeks.

  Baseline and 52 weeks.

• Percentage of Participants Achieving Body Weight Reduction Thresholds at 52 Weeks.

  52 weeks.

• Change From Baseline in Systolic Blood Pressure at 52 Weeks.

  Baseline and 52 weeks.

• Change From Baseline in Diastolic Blood Pressure at 52 Weeks.

  Baseline and 52 weeks.

Other Outcomes (11)

• Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at 52 Weeks.

  Baseline and 52 weeks.

• Mean Change From Baseline in Serum Cystatin C at 52 Weeks.

  Baseline and 52 weeks.

• Mean Change From Baseline in Alanine Aminotransferase (ALT) Levels at 52 Weeks.

  Baseline and 52 weeks.

Study Arms (2)

Cohort 1: Obesity Without T2DM

EXPERIMENTAL

Adults with obesity (BMI ≥30 kg/m²) without type 2 diabetes mellitus, receiving tirzepatide as part of standard clinical care.

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

Cohort 2: T2DM With or Without Obesity

EXPERIMENTAL

Adults with type 2 diabetes mellitus (with or without obesity), receiving tirzepatide as part of standard clinical care.

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

Interventions

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

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).

Also known as: Dual GIP/GLP-1 Receptor Agonist

Cohort 1: Obesity Without T2DM; Cohort 2: T2DM With or Without Obesity

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Clinical stability, defined as the absence of hospitalization related to diabetes or obesity complications within 3 months prior to screening.
• Adequate renal function, defined as an estimated glomerular filtration rate (eGFR) ≥45 mL/min/1.73m² calculated using the CKD-EPI equation.
• For participants enrolled in the obesity cohort: clinical diagnosis of obesity with BMI ≥30 kg/m², no prior diagnosis of diabetes mellitus (HbA1c \<6.5%), and at least one documented unsuccessful attempt at dietary weight-loss intervention within the previous 12 months.
• For participants enrolled in the type 2 diabetes mellitus (T2DM) cohort: established diagnosis of T2DM for at least 6 months prior to screening according to ADA 2025 criteria, HbA1c between 7.0% and 9.5% at screening confirmed at baseline, BMI ≥24 kg/m², and stable treatment on monotherapy or dual therapy with metformin, sulfonylureas, DPP-4 inhibitors, or SGLT-2 inhibitors for at least 3 months prior to screening.

You may not qualify if:

• 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.
• Clinically significant untreated thyroid dysfunction, including hypothyroidism or hyperthyroidism.
• Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.
• Major adverse cardiovascular event (MACE), including acute myocardial infarction, stroke, or hospitalization for heart failure within 6 months prior to screening.
• Heart failure classified as New York Heart Association (NYHA) Functional Class III or IV.
• Uncontrolled hypertension, defined as systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg despite optimal antihypertensive therapy.
• History of acute or chronic pancreatitis.
• Active inflammatory bowel disease or prior bariatric surgery.
• Clinically significant diabetic gastroparesis or other gastrointestinal motility disorders that may interfere with the absorption of concomitant oral medications.
• Use of systemic corticosteroids for more than 14 consecutive days within 3 months prior to screening.
• Treatment with oral anti-obesity medications (including orlistat, phentermine, naltrexone/bupropion, or topiramate) within 3 months prior to screening.
• Participation in another clinical trial involving an investigational medicinal product within 30 days prior to screening.

Sponsors & Collaborators

• Las Rías Medical Center: lead
• LABORATORIO DE PRODUCTOS ETICOS C.E.I.S.A: collaborator

Study Sites (1)

Centro Médico Las Rias

Asunción, Paraguay

RECRUITING

Related Links

• LAS RIAS MEDICAL CENTER will serve as the clinical research site where the present study will be conducted. This website provides access to the approvals issued by the Ethics Committee and by the National Directorate of Sanitary Surveillance (DINAVISA)
• CEI-INCAN is the DINAVISA-accredited Research Ethics Committee responsible for the ethical review and approval of this study.
• Dirección Nacional de Vigilancia Sanitaria - Paraguay

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2; Overweight; Metabolic Syndrome; Weight Loss

Interventions

Tirzepatide

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Body Weight Changes

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Study Officials

• ELIZABETH VALINOTTI DELMAS, MD

  LAS RIAS MEDICAL CENTER

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ELIZABETH VALINOTTI DELMAS, MD

CONTACT

+595 981 312 888; elizabeth.valinotti@lasrias.com.py

Sandra Soto Valiente

CONTACT

smsv81@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will receive subcutaneous injections of tirzepatide 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).

Study Record Dates

• First Submitted: April 26, 2026
• First Posted: May 14, 2026
• Study Start (Estimated): July 27, 2026
• Primary Completion (Estimated): August 10, 2027
• Study Completion (Estimated): August 10, 2027
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)