REAL-TIRZEPY

RecruitingPhase 4

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

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.

Lead sponsor

Las Rías Medical Center

Asset

Tirzepatide

Subcutaneous · GLP-1 / GIP dual

Listed sites

Recruiting sites

Enrollment

160

estimated

Study population

Obesity / overweight, Type 2 diabetes

Key I/E criteria

•BMI ≥30•HbA1c ≤6.5%•eGFR ≥45

Primary endpoints

•Body weight, % change•HbA1c, change•Treatment-emergent AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07588438

Org study IDEticos 01/25 V 1.1 03/12/2025

Timeline

Milestones

Study first posted2026-05-14actual

Last update posted2026-05-19actual

Study start2026-07-27estimated

Primary completion2027-08-10estimated

Study completion2027-08-10estimated

Assets

Investigational agents

Tirzepatide

Study populations

Who this study enrolls

Obesity / overweightType 2 diabetes

Eligibility

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

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.

Endpoints (32)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Weight & body composition

Cardiometabolic biomarkers

MASH / liver

Safety / tolerability / PK

Glycemic / diabetes

Renal / kidney

Other clinical outcomes

Other (unclassified)

Weight & body composition

7 endpoints

Primary/protocol endpoint

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

Time frame:Baseline and 52 weeks.

Body weight, % change

percent change from baseline, improvement

Secondary/protocol endpoint

Mean Change From Baseline in Body Weight at 52 Weeks.

Time frame:Baseline and 52 weeks.

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:Baseline and 52 weeks.

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:52 weeks.

threshold achievement, improvement

Secondary/protocol endpoint

Change From Baseline in Total Fat Mass Measured by Bioelectrical Impedance Analysis (BIA) at 52 Weeks.

Time frame:Baseline and 52 weeks.

Total fat mass

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Visceral Fat Mass Measured by Bioelectrical Impedance Analysis (BIA) at 52 Weeks.

Time frame:Baseline and 52 weeks.

Visceral fat, change

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Lean Body Mass Measured by Bioelectrical Impedance Analysis (BIA) at 52 Weeks.

Time frame:Baseline and 52 weeks.

Lean mass

change from baseline, improvement

Glycemic / diabetes

4 endpoints

Primary/protocol endpoint

Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at 52 Weeks.

Time frame:Baseline and 52 weeks.

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change From Baseline in Fasting Insulin at 52 Weeks.

Time frame:Baseline and 52 weeks.

change from baseline, improvement

Secondary/protocol endpoint

Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 52 Weeks.

Time frame:Baseline and 52 weeks.

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Participants Achieving HbA1c Targets (Cohort 2) at 52 Weeks.

Time frame:52 weeks.

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

MASH / liver

5 endpoints

Other/protocol endpoint

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

Time frame:Baseline and 52 weeks.

ALT, change

change from baseline, improvement

LOINC 1742-6

Other/protocol endpoint

Mean Change From Baseline in Aspartate Aminotransferase (AST) Levels at 52 Weeks.

Time frame:Baseline and 52 weeks.

AST, change

change from baseline, improvement

LOINC 1920-8

Other/protocol endpoint

Mean Change From Baseline in Gamma-glutamyl Transferase (GGT) Levels at 52 Weeks.

Time frame:Baseline and 52 weeks.

γ-GT, change

change from baseline, improvement

Other/protocol endpoint

Percentage of Participants With Improvement in Hepatic Steatosis Grade at 52 Weeks.

Time frame:Baseline and 52 weeks.

threshold achievement, improvement

Other/protocol endpoint

Mean Change From Baseline in Hepatic Fat Content via Ultrasound-Guided Attenuation Parameter (UGAP).

Time frame:Baseline and 52 weeks.

Liver fat content, change

change from baseline, improvement

Renal / kidney

2 endpoints

Other/protocol endpoint

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

Time frame:Baseline and 52 weeks.

eGFR, change

change from baseline, improvement

LOINC 98979-8

Other/protocol endpoint

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

Time frame:Baseline and 52 weeks.

change from baseline, improvement

Cardiometabolic biomarkers

7 endpoints

Secondary/protocol endpoint

Change From Baseline in Systolic Blood Pressure at 52 Weeks.

Time frame:Baseline and 52 weeks.

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Change From Baseline in Diastolic Blood Pressure at 52 Weeks.

Time frame:Baseline and 52 weeks.

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Percentage Change From Baseline in Total Cholesterol at 52 Weeks.

Time frame:Baseline and 52 weeks.

Total cholesterol, change

percent change from baseline, improvement

LOINC 2093-3

Secondary/protocol endpoint

Percentage Change From Baseline in LDL Cholesterol (LDL-C) at 52 Weeks.

Time frame:Baseline and 52 weeks.

LDL-C, change

percent change from baseline, improvement

LOINC 13457-7

Secondary/protocol endpoint

Percentage Change From Baseline in HDL Cholesterol (HDL-C) at 52 Weeks.

Time frame:Baseline and 52 weeks.

HDL-C, change

percent change from baseline, improvement

LOINC 2085-9

Secondary/protocol endpoint

Percentage Change From Baseline in Triglycerides at 52 Weeks.

Time frame:Baseline and 52 weeks.

Triglycerides, change

percent change from baseline, improvement

LOINC 2571-8

Secondary/protocol endpoint

Percentage Change From Baseline in High-sensitivity C-reactive Protein (hs-CRP) at 52 Weeks.

Time frame:Baseline and 52 weeks.

hs-CRP, change

percent change from baseline, improvement

LOINC 30522-7

Safety / tolerability / PK

5 endpoints

Primary/protocol endpoint

Number of Participants With Treatment-Emergent Adverse Events (TEAEs).

Time frame:Through week 52.

Treatment-emergent AEs (any)

event count, event

Secondary/protocol endpoint

Percentage of Scheduled Tirzepatide Doses Successfully Administered Through 52 Weeks.

Time frame:Through week 52.

descriptive

Other/protocol endpoint

Mean Change From Baseline in Thyroid-Stimulating Hormone (TSH) Levels at 52 Weeks.

Time frame:Baseline and 52 weeks.

Thyroid event

change from baseline, descriptive

Other/protocol endpoint

Mean Change From Baseline in Free Thyroxine (FT4) Levels at 52 Weeks.

Time frame:Baseline and 52 weeks.

change from baseline, descriptive

Other/protocol endpoint

Mean Change From Baseline in Serum Calcitonin Levels at 52 Weeks.

Time frame:Baseline and 52 weeks.

Thyroid event

change from baseline, descriptive

Other clinical outcomes

1 endpoint

Other/protocol endpoint

Mean Change From Baseline in Apnea-Hypopnea Index (AHI) in the OSA Subgroup at 52 Weeks.

Time frame:Baseline and 52 weeks.

AHI, change

change from baseline, improvement

Other (unclassified)

1 endpoint

Secondary/protocol endpoint

Percentage of Participants Completing the 52-Week Follow-up Period.

Time frame:Through week 52.

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 1, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.