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Prevention of Progression of Prediabetes, Obesity and CV Risk

NCT06446531 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2025-11-12

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Placebo

Oral tablet administered once daily

DRUG

Rybelsus Tablet

Oral tablet started at a 3mg dose once daily and increased to 7mg once daily or maximum tolerable dose.

DRUG

Jardiance 25Mg Tablet

Oral 25 mg Sodium-Glucose Co-Transporter (SGLT2) inhibitor administered once daily

DRUG

Metformin

Oral tablet started at a dose of 500mg with an increase of 500mg weekly up to a maximum dose of 2000mg (4 tablets)

DRUG

Actos

Oral tablet dosed at 15mg once daily

Sponsors & Collaborators

  • Baptist Health Foundation of San Antonio

    collaborator UNKNOWN

  • The University of Texas Health Science Center at San Antonio

    lead OTHER

Principal Investigators

  • Carolina Solis-Herrera, MD · The University of Texas Health Science Center at San Antonio

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-11
Primary Completion
2027-07-31
Completion
2027-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06446531 on ClinicalTrials.gov