Prevention of Progression of Prediabetes, Obesity and CV Risk

What Was Tested

This registered phase 1 trial tested Semaglutide.

The investigators are studying how to help people with prediabetes (Pre-DM) and obesity.

The goal is to use new and affordable treatments to bring blood sugar levels back to normal and help participants to lose weight.

It had four arms (groups): Placebo (placebo comparator), SGLT2 inhibitor Group (experimental), GLP-1 Receptor Agonist Group (experimental) and Metformin with SGLT2 Inhibitor Group (experimental).

Randomization will occur 1:1:1:1 to this placebo group.

Randomization will occur 1:1:1:1 to this SGLT2 inhibitor group.

Randomization will occur 1:1:1:1 to this GLP-1 receptor agonist group.

The registry classes the interventions as drug.

More on the Plan

While taking part in this study, participants will be asked to attend approximately 16 visits with the researchers or study staff.

Study participants are assigned (single-blinded, only the study team will know the assigned group) to one of 4 study groups, receiving a 6-month treatment with Nutritional Consultation + either SGLT2 Inhibitor (Empagliflozin), Rybelsus (GLP1 Receptor Agonist), Metformin + Pioglitazone, or placebo.

A placebo is an inactive, harmless substance that looks like the other study drugs.

This study does not require overnight stays at the hospital in any of the study groups.

Who Took Part

Enrollment: 64 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: Patients will have an established diagnosis of pre-Diabetes Mellitus (DM) before the screening visit, documented by an acceptable modality in the last 6 months. Age ≥ 18 years old. Body Mass Index (BMI)=25-40 kg/m2. Blood Pressure (BP) \<160/100. Body weight must be stable (±5 pounds) over the last 3 months.

The full record lists 16 inclusion and 16 exclusion criteria; among the exclusions: patients currently on one of the selected therapies; extended diagnoses with type 2 diabetes; pregnancy, lactation, women of childbearing age (wocba) unwilling to use contraception.

How the Study Was Run

Design: randomized, parallel-group and single-blind.

Because people in this Semaglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Only one side, usually the participants, was kept unaware of whether Semaglutide was given.

Those kept unaware of assignments: participant.

It started in 2024-09-11 with completion listed for 2027-07.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Hemoglobin A1c Level (HBA1c) (time frame: Baseline and 6 months).

It also tracked 8 secondary outcomes, for example Body Mass Index (BMI), Percentage of Body Fat Composition, Left Ventricular Function, Measure of phosphocreatine k-value, Measure of oxidative capacity and Measure of intramyocellular lipids (IMCL).

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Semaglutide in 64 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.