A Phase 4 interventional study of Tirzepatide (LIPOLESS de Laboratorio de Productos Eticos C.E.I.S.A.) in Obesity and Diabetes Mellitus, Type 2, sponsored by Las Rías Medical Center. Recruiting at 1 site in Paraguay. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-05-19.
Sponsored by Las Rías Medical Center · Phase 4, Interventional, and Treatment
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.
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:
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:
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.
11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.
This study's planned enrollment of 160 is above the median of 67 across 9,006 interventional studies indexed under Obesity.
Browse Obesity studies →This is the only study on the registry with Las Rías Medical Center as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.)
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.)
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
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.
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.
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.
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.
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.
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.
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.
Change From Baseline in Diastolic Blood Pressure at 52 Weeks.
Assessment of the absolute change in resting diastolic blood pressure.
Time frame: Baseline and 52 weeks.
Percentage Change From Baseline in Total Cholesterol at 52 Weeks.
Assessment of percentage change in fasting total cholesterol concentrations from baseline to week 52.
Time frame: Baseline and 52 weeks.
Percentage Change From Baseline in LDL Cholesterol (LDL-C) at 52 Weeks.
Assessment of percentage change in fasting LDL cholesterol concentrations from baseline to week 52.
Time frame: Baseline and 52 weeks.
Percentage Change From Baseline in HDL Cholesterol (HDL-C) at 52 Weeks.
Assessment of percentage change in fasting HDL cholesterol concentrations from baseline to week 52.
Time frame: Baseline and 52 weeks.
Percentage Change From Baseline in Triglycerides at 52 Weeks.
Assessment of percentage change in fasting triglyceride concentrations from baseline to week 52.
Time frame: Baseline and 52 weeks.
Change From Baseline in Total Fat Mass Measured by Bioelectrical Impedance Analysis (BIA) at 52 Weeks.
Evaluation of changes in total fat mass measured by bioelectrical impedance analysis (BIA).
Time frame: Baseline and 52 weeks.
Change From Baseline in Visceral Fat Mass Measured by Bioelectrical Impedance Analysis (BIA) at 52 Weeks.
Evaluation of changes in visceral fat mass measured by bioelectrical impedance analysis (BIA).
Time frame: Baseline and 52 weeks.
Change From Baseline in Lean Body Mass Measured by Bioelectrical Impedance Analysis (BIA) at 52 Weeks.
Evaluation of changes in lean body mass measured by bioelectrical impedance analysis (BIA).
Time frame: Baseline and 52 weeks.
Change From Baseline in Fasting Insulin at 52 Weeks.
Assessment of the absolute change in fasting serum insulin concentrations from baseline to week 52.
Time frame: Baseline and 52 weeks.
Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) at 52 Weeks.
Assessment of insulin resistance using the calculated Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) from baseline to week 52.
Time frame: Baseline and 52 weeks.
Percentage Change From Baseline in High-sensitivity C-reactive Protein (hs-CRP) at 52 Weeks.
Assessment of systemic inflammation via hs-CRP percentage change.
Time frame: Baseline and 52 weeks.
Percentage of Participants Achieving HbA1c Targets (Cohort 2) at 52 Weeks.
Percentage of participants with T2DM reaching HbA1c≤7.0%, 6.5%, and 5.7%.
Time frame: 52 weeks.
Percentage of Scheduled Tirzepatide Doses Successfully Administered Through 52 Weeks.
Treatment adherence based on the proportion of scheduled tirzepatide doses successfully administered during the 52-week follow-up period.
Time frame: Through week 52.
Percentage of Participants Completing the 52-Week Follow-up Period.
Study retention based on the proportion of participants completing the final scheduled week-52 evaluation.
Time frame: Through week 52.
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.
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.
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.
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.
Mean Change From Baseline in Gamma-glutamyl Transferase (GGT) Levels at 52 Weeks.
Assessment of liver function through the absolute change in serum gamma-glutamyl transferase (GGT) concentrations from baseline to week 52.
Time frame: Baseline and 52 weeks.
Percentage of Participants With Improvement in Hepatic Steatosis Grade at 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.
Time frame: Baseline and 52 weeks.
Mean Change From Baseline in Hepatic Fat Content via Ultrasound-Guided Attenuation Parameter (UGAP).
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).
Time frame: Baseline and 52 weeks.
Mean Change From Baseline in Thyroid-Stimulating Hormone (TSH) Levels at 52 Weeks.
Assessment of thyroid function through the absolute change in serum thyroid-stimulating hormone (TSH) concentrations from baseline to week 52.
Time frame: Baseline and 52 weeks.
Mean Change From Baseline in Free Thyroxine (FT4) Levels at 52 Weeks.
Assessment of thyroid function through the absolute change in serum free thyroxine (FT4) concentrations from baseline to week 52.
Time frame: Baseline and 52 weeks.
Mean Change From Baseline in Serum Calcitonin Levels at 52 Weeks.
Assessment of thyroid safety through the absolute change in serum calcitonin concentrations from baseline to week 52.
Time frame: Baseline and 52 weeks.
Mean Change From Baseline in Apnea-Hypopnea Index (AHI) in the OSA Subgroup at 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).
Time frame: Baseline and 52 weeks.
Plan to share: No — 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.
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Studies of the drug tested here: Tirzepatide