Pharmacogenetics of the Response to GLP-1 in Mexican-Americans With Prediabetes

What Was Tested

The trial (phase 4) is built around Semaglutide.

It had 1 arm (groups): Semaglutide (experimental).

The registry classes the interventions as drug.

More on the Plan

However, these associations do not provide a clear mechanistic relationship between genotype and phenotype.

Transcriptomic analyses will uncover many of these mechanisms.

Procedures include serial measurements of plasma glucose, insulin, C-peptide, and GLP-1, and peripheral blood collection for RNA sequencing.

Who Took Part

300 planned participants were the target.

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Men and women, ages 18 years and older.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: pregnant or breastfeeding women; medications: metformin, dpp-4 inhibitors, glp-1 receptor agonists, sglt-2 inhibitors, thiazolidinediones, insulin, sulfonylureas, meglitinides, alpha-glucosidase inhibitors, and/or corticosteroids over the last 3 months; active malignancy.

How the Study Was Run

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

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2021-11-22 with completion listed for 2026-10-31.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Mean change in beta cell responsivity (time frame: 12 weeks). Insulin Sensitivity (time frame: 12 weeks). Disposition Index (time frame: 12 weeks).

It also tracked 6 secondary outcomes, for example Mean change in glucose Area Under the Curve (AUC), Mean change in C-peptide Area Under the Curve (AUC), Change in hemoglobin A1C, Mean change in insulin Area Under the Curve (AUC), Creation of eQTL-based disease prediction models and Polygenic prediction model for GLP-1 therapy-associated outcomes.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Semaglutide in 300 people.

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

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