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Pre-DM
RecruitingPhase 1Prevention of Progression of Prediabetes, Obesity and CV Risk
Pioneering and Affordable Strategies to Prevent Progression of Prediabetes, Obesity and CV Risk in Hispanics
Asset
Semaglutide
GLP-1 agonist
Listed sites
1
Recruiting sites
1
Enrollment
64
estimated
Study population
Obesity / overweight, Prediabetes / glucose intolerance
Key I/E criteria
•BMI 25-40•HbA1c 5.7-6.4%•eGFR ≥30
Primary endpoint
•HbA1c, change
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. 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.
2. Age ≥ 18 years old
3. Body Mass Index (BMI)=25-40 kg/m2
4. Glycated Hemoglobin (HbA1c) = 5.7-6.4%
5. Blood Pressure (BP) <160/100
6. Estimated Glomerular Filtration Rate (eGFR) ≥30 ml/min•1.73m2
7. Body weight must be stable (±5 pounds) over the last 3 months.
8. 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.
9. Hispanic ethic group
10. Willing to adhere to medication regimen for up to 6 months.
11. Male or female, if female, met these criteria:
1. Not pregnant or breast-feeding
2. Negative pregnancy test result at visit 1 (screening)
3. 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 pills, or a vasectomized partner prior to receiving the first dose of study medication
12. Does not suffer from severe claustrophobia
13. No contraindication for Magnetic Resonance Imaging (MRI) (metal plates, screws, shrapnel, pins, or cardiac pacemaker)
Exclusion criteria
1. Patients currently on one of the selected therapies
2. Extended diagnoses with Type 2 Diabetes
3. Pregnancy, lactation, women of childbearing age (WOCBA) unwilling to use contraception
4. Known allergy/sensitivity to study drugs or their ingredients
5. Major oncologic diagnosis in the last 5 years
6. Current drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements
7. Inability or unwillingness of individual or legal guardian/representative to give written informed consent
8. Major organ or metabolic diseases, or physical limitations that will not allow the subject to complete the study
9. Myocardial infraction, coronary artery bypass graft surgery, or other major cardiovascular event in the past 60 days
10. Heart transplant recipient or listed for a heart transplant
11. Currently implanted left ventricular assist device
12. Cardiomyopathy based on infiltrative or cumulative hypertrophic obstructive cardiomyopathy or known pericardial constriction
13. Any severe (obstructive or regurgitant) valvular heart disease, expected to lead to surgery during the trial period
14. 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
15. Implanted cardioverter defibrillator within 3 months prior to screening
16. Cardiac resynchronization therapy
Endpoints (9)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
2 endpointsBody Mass Index (BMI)
Time frame:Baseline and 6 months
BMI, change
change from baseline, improvement
Percentage of Body Fat Composition
Time frame:Baseline and 6 months
Total fat mass
change from baseline, improvement
Glycemic / diabetes
1 endpointHemoglobin A1c Level (HBA1c)
Time frame:Baseline and 6 months
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Patient-reported / QoL
1 endpointPatient Reported Outcomes (PROMIS)
Time frame:Baseline and 6 months
change from baseline, improvement
Other (unclassified)
5 endpointsLeft Ventricular Function
Time frame:Baseline and 6 months
change from baseline, descriptive
Measure of phosphocreatine k-value
Time frame:Baseline and 6 months
change from baseline, descriptive
Measure of oxidative capacity
Time frame:Baseline and 6 months
change from baseline, descriptive
Measure of intramyocellular lipids (IMCL)
Time frame:Baseline and 6 months
change from baseline, descriptive
Measure of extramyocellular lipids (EMCL)
Time frame:Baseline and 6 months
change from baseline, descriptive
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.