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Pre-DM

RecruitingPhase 1

Prevention 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 25-40HbA1c 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

NCT IDNCT06446531
Org study IDSTUDY00000485 Pre-DM

Timeline

Milestones

Study first posted2024-06-06actual
Study start2024-09-11actual
Last update posted2025-11-12actual
Primary completion2027-07estimated (month precision)
Study completion2027-07estimated (month precision)

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightPrediabetes / glucose intolerance

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

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

Other (unclassified)
5
Weight & body composition
2
Glycemic / diabetes
1
Patient-reported / QoL
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Body Mass Index (BMI)

Time frame:Baseline and 6 months

BMI, change

change from baseline, improvement

Secondary/protocol endpoint

Percentage of Body Fat Composition

Time frame:Baseline and 6 months

Total fat mass

change from baseline, improvement

Glycemic / diabetes

1 endpoint
Primary/protocol endpoint

Hemoglobin A1c Level (HBA1c)

Time frame:Baseline and 6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Patient Reported Outcomes (PROMIS)

Time frame:Baseline and 6 months

change from baseline, improvement

Other (unclassified)

5 endpoints
Secondary/protocol endpoint/low confidence

Left Ventricular Function

Time frame:Baseline and 6 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Measure of phosphocreatine k-value

Time frame:Baseline and 6 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Measure of oxidative capacity

Time frame:Baseline and 6 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Measure of intramyocellular lipids (IMCL)

Time frame:Baseline and 6 months

change from baseline, descriptive

Secondary/protocol endpoint/low confidence

Measure of extramyocellular lipids (EMCL)

Time frame:Baseline and 6 months

change from baseline, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

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.