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Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Paraguay. (REAL-TIRZEPY)

17. maj 2026 opdateret af: Las Rías Medical Center

Prospective Cohort Study to Evaluate the Efficacy, Safety, and Tolerability of Tirzepatide in Real-World Conditions in Persons With Obesity Without Diabetes and Type 2 Diabetes Mellitus With or Without Obesity in Paraguay.

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Innovation and Regional Significance This study represents a pioneering milestone as the first prospective, long-term real-world evidence (RWE) investigation of tirzepatide in Paraguay. While global randomized clinical trials have established efficacy within controlled environments, this research addresses a critical knowledge gap by evaluating the performance of dual GIP/GLP-1 receptor agonism within a South American cohort. By documenting metabolic outcomes, safety, and adherence under routine clinical conditions-shaped by unique genetic, dietary, and socioeconomic factors-this project provides essential data for the regional medical community and sets a new benchmark for metabolic excellence in the region.

Study Design and Long-Term Follow-Up

The study is structured as a 52-week prospective cohort investigation, a duration that exceeds most regional observational studies, allowing for the assessment of weight loss maintenance and long-term glycemic stability. Participants are divided into two distinct metabolic profiles:

  • Cohort 1 (Obesity Focus): Adults with BMI ≥30 kg/m² without T2DM.
  • Cohort 2 (Metabolic Synergy): Adults with T2DM, with or without obesity. This dual-track approach allows for a comprehensive analysis of tirzepatide's pleiotropic effects across the spectrum of metabolic disease.

Treatment Protocol and Nutritional Support All participants receive tirzepatide (Lipoless by Laboratorio de Productos Eticos C.E.I.S.A) via subcutaneous injection once weekly. The treatment follows a standardized titration schedule starting at 2.5 mg, with dose escalations every 4 weeks based on individual clinical response and gastrointestinal tolerability. The pharmacological intervention is supported by a structured hyperproteic, low-carbohydrate nutritional plan (approximately 1,500 kcal/day) aimed at optimizing metabolic results and supporting healthy weight loss. Furthermore, in alignment with standard medical practice, all subjects are prescribed a standardized physical activity regimen and comprehensive healthy lifestyle modifications to ensure a holistic approach to long-term metabolic health.

Advanced Monitoring and Diagnostics To ensure high-quality data collection, the study utilizes precise diagnostic tools at specific intervals:

  • Body Composition: Systematic use of bioelectrical impedance analysis (InBody) to monitor changes in fat mass, visceral fat, and lean body mass at every visit.
  • Imaging: Standardized abdominal and thyroid ultrasound evaluations conducted at the Instituto Radiológico Calvo (weeks 0, 24, 52).
  • Functional Assessment: Measurement of muscle strength to correlate pharmacological efficacy with physical performance at very visit
  • Biochemical Analysis: Comprehensive laboratory panels processed by Laboratorio Díaz Gill to monitor glycemic control, lipid profiles, and safety markers (weeks 0, 24, 52).

Regulatory Rigor and Safety Operating under the strict oversight of the CEI-INCAN Ethics Committee and with the authorization of DINAVISA, the study adheres to International Council for Harmonisation (ICH) Good Clinical Practice guidelines. Safety is monitored through a robust pharmacovigilance system, with a specific focus on gastrointestinal tolerability and hepatobiliary safety, recorded via the PowerMed electronic data capture system.

Exclusionary Clarity In order to isolate the specific effects of incretin-based therapy in a real-world setting, this study strictly excludes patients using insulin, focusing on the potential of tirzepatide as a foundational therapy for metabolic health.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

160

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Paraguay
      • Asunción, Paraguay
        • Rekruttering
        • Centro Médico Las Rias
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • ELIZABETH VALINOTTI DELMAS, MD
        • Underforsker:
          • SANDRA SOTO VALIENTE, MD
        • Underforsker:
          • MARIA LIS ALARCON BERNAL, MD
        • Underforsker:
          • SADY ARZAMENDIA DAVALOS, MD
        • Underforsker:
          • FRANCISCO CABRERA LOPEZ, MD
        • Underforsker:
          • KARENN CERMEÑO HERRERA, MD
        • Underforsker:
          • FEDERICO FARIÑA MENDIETA, MD
        • Underforsker:
          • NADIA GARCIA FERNANDEZ, MD
        • Underforsker:
          • ANDRES GIMENEZ BENITEZ, MD
        • Underforsker:
          • MARIA CRISTINA JIMENEZ BAZZANO, MD
        • Underforsker:
          • HELEN LOPEZ OVELAR, MD
        • Underforsker:
          • MARIA GALIANA RODRIGUEZ CABALLERO, MD
        • Underforsker:
          • FABIOLA ROMERO GOMEZ, MD
        • Underforsker:
          • LUZ VAZQUEZ VERA, MD
        • Underforsker:
          • MIGUEL CALVO VILLALBA, MD
        • Underforsker:
          • ALCIDES CHAUX SALINAS, MD
        • Underforsker:
          • FRANCISCO ECHAURI DOMINGUEZ, MD

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • Moderate to advanced chronic kidney disease defined as eGFR <45 mL/min/1.73m² or requirement for dialysis.
  • Active liver disease or transaminase levels (ALT/AST) greater than 3 times the upper limit of normal.
  • Active malignancy or history of cancer within the previous 5 years, except for completely resected basal cell or squamous cell skin carcinoma.
  • Uncontrolled major psychiatric disorders or history of suicide attempt within the previous 2 years.
  • Confirmed or suspected pregnancy, including positive serum beta-hCG test at screening, or active breastfeeding.
  • Intention to become pregnant during the study period.
  • Women of childbearing potential unwilling to use effective contraceptive methods (hormonal, intrauterine, or dual-barrier) throughout the study and for 3 months after the final dose.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Cohort 1: Obesity Without T2DM
Adults with obesity (BMI ≥30 kg/m²) without type 2 diabetes mellitus, receiving tirzepatide as part of standard clinical care.
Medicin: 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).
Andre navne:
  • Dual GIP/GLP-1 Receptor Agonist
Eksperimentel: Cohort 2: T2DM With or Without Obesity
Adults with type 2 diabetes mellitus (with or without obesity), receiving tirzepatide as part of standard clinical care.
Medicin: 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).
Andre navne:
  • Dual GIP/GLP-1 Receptor Agonist

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Percent Change From Baseline in Body Weight at 52 Weeks.
Tidsramme: Baseline and 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.
Tidsramme: Baseline and 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).
Tidsramme: Through week 52.
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.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change From Baseline in Body Weight at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Change in absolute body weight from baseline to week 52.
Baseline and 52 weeks.
Mean Change From Baseline in Body Mass Index (BMI) at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Change in BMI calculated as weight in kilograms divided by height in meters squared (kg/m2).
Baseline and 52 weeks.
Percentage of Participants Achieving Body Weight Reduction Thresholds at 52 Weeks.
Tidsramme: 52 weeks.
Percentage of participants achieving ≥5%, 10%, 15%, 20%, 25%, and 30% reduction from baseline body weight.
52 weeks.
Change From Baseline in Systolic Blood Pressure at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of the absolute change in resting systolic blood pressure.
Baseline and 52 weeks.
Change From Baseline in Diastolic Blood Pressure at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of the absolute change in resting diastolic blood pressure.
Baseline and 52 weeks.
Percentage Change From Baseline in Total Cholesterol at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of percentage change in fasting total cholesterol concentrations from baseline to week 52.
Baseline and 52 weeks.
Percentage Change From Baseline in LDL Cholesterol (LDL-C) at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of percentage change in fasting LDL cholesterol concentrations from baseline to week 52.
Baseline and 52 weeks.
Percentage Change From Baseline in HDL Cholesterol (HDL-C) at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of percentage change in fasting HDL cholesterol concentrations from baseline to week 52.
Baseline and 52 weeks.
Percentage Change From Baseline in Triglycerides at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of percentage change in fasting triglyceride concentrations from baseline to week 52.
Baseline and 52 weeks.
Change From Baseline in Total Fat Mass Measured by Bioelectrical Impedance Analysis (BIA) at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Evaluation of changes in total fat mass measured by bioelectrical impedance analysis (BIA).
Baseline and 52 weeks.
Change From Baseline in Visceral Fat Mass Measured by Bioelectrical Impedance Analysis (BIA) at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Evaluation of changes in visceral fat mass measured by bioelectrical impedance analysis (BIA).
Baseline and 52 weeks.
Change From Baseline in Lean Body Mass Measured by Bioelectrical Impedance Analysis (BIA) at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Evaluation of changes in lean body mass measured by bioelectrical impedance analysis (BIA).
Baseline and 52 weeks.
Change From Baseline in Fasting Insulin at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of the absolute change in fasting serum insulin concentrations from baseline to week 52.
Baseline and 52 weeks.
Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of insulin resistance using the calculated Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to week 52.
Baseline and 52 weeks.
Percentage Change From Baseline in High-sensitivity C-reactive Protein (hs-CRP) at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of systemic inflammation via hs-CRP percentage change.
Baseline and 52 weeks.
Percentage of Participants Achieving HbA1c Targets (Cohort 2) at 52 Weeks.
Tidsramme: 52 weeks.
Percentage of participants with T2DM reaching HbA1c≤7.0%, 6.5%, and 5.7%.
52 weeks.
Percentage of Scheduled Tirzepatide Doses Successfully Administered Through 52 Weeks.
Tidsramme: Through week 52.
Treatment adherence based on the proportion of scheduled tirzepatide doses successfully administered during the 52-week follow-up period.
Through week 52.
Percentage of Participants Completing the 52-Week Follow-up Period.
Tidsramme: Through week 52.
Study retention based on the proportion of participants completing the final scheduled week-52 evaluation.
Through week 52.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) at 52 Weeks.
Tidsramme: Baseline and 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.
Baseline and 52 weeks.
Mean Change From Baseline in Serum Cystatin C at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Evaluation of renal function through changes in serum Cystatin C concentrations from baseline to week 52.
Baseline and 52 weeks.
Mean Change From Baseline in Alanine Aminotransferase (ALT) Levels at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of liver function through the absolute change in serum alanine aminotransferase (ALT) concentrations from baseline to week 52.
Baseline and 52 weeks.
Mean Change From Baseline in Aspartate Aminotransferase (AST) Levels at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of liver function through the absolute change in serum aspartate aminotransferase (AST) concentrations from baseline to week 52.
Baseline and 52 weeks.
Mean Change From Baseline in Gamma-glutamyl Transferase (GGT) Levels at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of liver function through the absolute change in serum gamma-glutamyl transferase (GGT) concentrations from baseline to week 52.
Baseline and 52 weeks.
Percentage of Participants With Improvement in Hepatic Steatosis Grade at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of the proportion of participants with baseline NAFLD demonstrating improvement in hepatic steatosis grade on abdominal ultrasound from baseline to week 52. An objective measurement of hepatic fat load will be performed using the ultrasound-guided attenuation parameter (UGAP, USAT) which calculates the attenuation of ultrasound in a region of interest, expressed in dB/cm/MHz.
Baseline and 52 weeks.
Mean Change From Baseline in Hepatic Fat Content via Ultrasound-Guided Attenuation Parameter (UGAP).
Tidsramme: Baseline and 52 weeks.
Quantitative assessment of hepatic fat load using the ultrasound-guided attenuation parameter (UGAP/USAT). This technology calculates the attenuation coefficient of the ultrasound signal within a specified liver region of interest (ROI) to provide a precise objective measurement of steatosis. Unit of Measure: Decibels per centimeter per megahertz (dB/cm/MHz).
Baseline and 52 weeks.
Mean Change From Baseline in Thyroid-Stimulating Hormone (TSH) Levels at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of thyroid function through the absolute change in serum thyroid-stimulating hormone (TSH) concentrations from baseline to week 52.
Baseline and 52 weeks.
Mean Change From Baseline in Free Thyroxine (FT4) Levels at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of thyroid function through the absolute change in serum free thyroxine (FT4) concentrations from baseline to week 52.
Baseline and 52 weeks.
Mean Change From Baseline in Serum Calcitonin Levels at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Assessment of thyroid safety through the absolute change in serum calcitonin concentrations from baseline to week 52.
Baseline and 52 weeks.
Mean Change From Baseline in Apnea-Hypopnea Index (AHI) in the OSA Subgroup at 52 Weeks.
Tidsramme: Baseline and 52 weeks.
Evaluation of sleep apnea severity by measuring the number of apnea and hypopnea events per hour of sleep in participants with moderate-to-severe OSA at baseline (AHI≥15 events/h).
Baseline and 52 weeks.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Las Rías Medical Center

Samarbejdspartnere

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

Efterforskere

  • Ledende efterforsker: ELIZABETH VALINOTTI DELMAS, MD, LAS RIAS MEDICAL CENTER

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

27. juli 2026

Primær færdiggørelse (Anslået)

10. august 2027

Studieafslutning (Anslået)

10. august 2027

Datoer for studieregistrering

Først indsendt

26. april 2026

Først indsendt, der opfyldte QC-kriterier

10. maj 2026

Først opslået (Faktiske)

14. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

19. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • Eticos 01/25 V 1.1 03/12/2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Individual participant data will not be shared to protect participant privacy and maintain confidentiality in accordance with the study's institutional ethics committee approval and local data protection regulations in Paraguay.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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