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Prevention study for Pre-Diabetes
Official title Prevention of Progression of Prediabetes, Obesity and CV Risk
ClinicalTrials.gov ID: NCT06446531
What this study is testing
What is Rybelsus Tablet?
Rybelsus Tablet is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for pre-diabetes.
Also referred to as Semaglutide.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients will have an established diagnosis of pre-Diabetes Mellitus (DM) before the screening visit, documented by an acceptable modality in the...
- Age ≥ 18 years old
- Body Mass Index (BMI)=25-40 kg/m2
- Glycated Hemoglobin (HbA1c) = 5.7-6.4%
- Blood Pressure (BP) \<160/100
You likely can't join if
- 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
- Known allergy/sensitivity to study drugs or their ingredients
- Major oncologic diagnosis in the last 5 years
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
See the full eligibility criteria
- 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
- Glycated Hemoglobin (HbA1c) = 5.7-6.4%
- Blood Pressure (BP) \<160/100
- Estimated Glomerular Filtration Rate (eGFR) ≥30 ml/min 1.73m2
- Body weight must be stable (±5 pounds) over the last 3 months.
- Oral diuretics, if prescribed to the patient according to local guidelines and discretion of the investigator, should be stable for at least 1 week prior to randomization.
- Hispanic ethic group
- Willing to adhere to medication regimen for up to 6 months.
- Male or female, if female, met these criteria:
- Not pregnant or breast-feeding
- Negative pregnancy test result at visit 1 (screening)
- During the entire study, women of childbearing potential (WOCBP) including peri-menopausal women who have a menstrual period within 1 year must practice appropriate, and effective birth control, either implants or...
- Does not suffer from severe claustrophobia
- No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws, shrapnel, pins, or cardiac pacemaker)
- 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
- Known allergy/sensitivity to study drugs or their ingredients
- Major oncologic diagnosis in the last 5 years
- Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
- Inability or unwillingness of individual or legal guardian/representative to give written informed consent
- Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study
- Myocardial infraction, coronary artery bypass graft surgery, or other major cardiovascular event in the past 60 days
- Heart transplant recipient or listed for a heart transplant
- Currently implanted left ventricular assist device
- Cardiomyopathy based on infiltrative or cumulative hypertrophic obstructive cardiomyopathy or known pericardial constriction
- Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period
- Acute decompensated heart failure requiring intravenous diuretics, vasodilators, inotropic agents, or mechanical support within 1 week of screening and during the screening period prior to randomization
- Implanted cardioverter defibrillator within 3 months prior to screening
- Cardiac resynchronization therapy
The study team makes the final eligibility decision.
Where it's taking place
- San Antonio, Texas, United States
Compensation & support
A stipend or compensation may be offered.
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Antonio, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.