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

What Was Tested

In this phase 4 trial, researchers set out to test Tirzepatide.

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).

It had two arms (groups): Cohort 1: Obesity Without T2DM (experimental) and Cohort 2: T2DM With or Without Obesity (experimental).

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

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

The registry classes the interventions as drug.

More on the Plan

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.

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.

Who Took Part

160 planned participants were the target.

It was open to people of any sex aged from 18 years up to 70 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 8 inclusion and 22 exclusion criteria; among the exclusions: 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.

How the Study Was Run

It was run as a non-randomized, single-group and open-label study.

Nothing was hidden in this open-label Tirzepatide study: the participants and staff both knew the treatment.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2026-07-27 with completion listed for 2027-08-10.

It ran at 1 site in Paraguay.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean Percent Change From Baseline in Body Weight at 52 Weeks (time frame: Baseline and 52 weeks). Mean Change From Baseline in Glycated Hemoglobin (HbA1c) at 52 Weeks (time frame: Baseline and 52 weeks). Number of Participants With Treatment-Emergent Adverse Events (TEAEs) (time frame: Through week 52).

It also tracked 18 secondary outcomes, for example Mean Change From Baseline in Body Weight at 52 Weeks, Mean Change From Baseline in Body Mass Index (BMI) at 52 Weeks, Change From Baseline in Systolic Blood Pressure at 52 Weeks, Change From Baseline in Diastolic Blood Pressure at 52 Weeks, Percentage Change From Baseline in Total Cholesterol at 52 Weeks and Percentage Change From Baseline in LDL Cholesterol (LDL-C) at 52 Weeks.

What This Means in Plain Language

Put simply, this is a phase 4, non-randomized trial of Tirzepatide in 160 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Tirzepatide compound page, all human trials.