Prevention of Progression of Prediabetes, Obesity and CV Risk

NCT06446531 · Recruiting

Last updated 2026-05-28

This clinical trial is testing whether a treatment can help prevent prediabetes from worsening, reduce obesity, and lower the risk of heart disease in adults with prediabetes.

Status Recruiting Currently enrolling participants.

Phase Phase 1 Checks safety and dosing in a small group.

Type Interventional (clinical trial)

Design Randomized, single-blind treatment study

Participants 64 people Planned (estimated).

Who can join Ages 18+ · all sexes

Timeline Started 2024-09 · est. completion 2027-07

Where 1 site · United States

What this study is testing ClinicalTrials.gov NCT06446531 ↗

Description as written by the study sponsor.

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. The investigators also want to reduce participants risk of heart problems. The study team will look at how these treatments affect metabolism and other body functions to help find new ways to treat diabetes and obesity in the future.

Treatments tested

Placebo also known as Zebbo Drug

Oral tablet administered once daily
Rybelsus Tablet also known as Semaglutide Drug

Oral tablet started at a 3mg dose once daily and increased to 7mg once daily or maximum tolerable dose.
Jardiance 25Mg Tablet also known as Empagliflozin Drug

Oral 25 mg Sodium-Glucose Co-Transporter (SGLT2) inhibitor administered once daily
Metformin also known as Metformin Hydrochloride Drug

Oral tablet started at a dose of 500mg with an increase of 500mg weekly up to a maximum dose of 2000mg (4 tablets)
Actos also known as Pioglitazone Drug

Oral tablet dosed at 15mg once daily

Main thing measured	Hemoglobin A1c Level (HBA1c)
Sponsor	The University of Texas Health Science Center at San Antonio
Conditions studied	Pre-Diabetes, Weight, Body, Cardiovascular Diseases
GLP-1 drugs	—

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06446531 ↗