RecruitingEarly Phase 1

Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs

United States20 participantsStarted 2025-09-02

Plain-language summary

This study will identify the potential benefits of regulating platelet activation with sotagliflozin compared to other FDA-approved drugs known to limit platelet activation.

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: \- Exclusion Criteria: * Students under the direct supervision of Dr. Michael Holinstat * Subjects diagnosed with Type I diabetes or those with ketoacidosis * Subjects with a history of alcohol abuse, pancreatitis or pancreatic surgery, or subjects taking a ketogenic diet * Women who self-identify as being pregnant or who are planning to become pregnant during the 14 week study will be excluded from the study, as are those who are breastfeeding (women enrolled in the study will be given a urine pregnancy test at the start of each drug administration period to confirm pregnancy status) * Subjects with hypersensitivity to aspirin, clopidogrel, apixaban, or sotagliflozin are excluded * have active bleeding, or who have who have a history of balanitis or balanoposthitis, genital mycotic infections, or a planned elective surgical/dental procedure 1 month prior to or following completion of study * Subjects who have taken Non-Steroidal Anti-Inflammatory Drugs (NSAIDS; examples of NSAIDS are Ibuprofen (Advil, Motrin) and Naproxen (Aleve)) or aspirin within 7 days prior to the study or anticoagulants within 10 days prior to the study * individuals currently taking SSRI's (for example, Fluoxetine (Prozac), Sertraline (Zoloft), Paroxetine (Paxil), Citalopram (Celexa), and Escitalopram (Lexapro).), SNRI's (Duloxetine (Cymbalta), Venlafaxine (Effexor XR), Desvenlafaxine (Pristiq), and Levomilnacipran (Fetzima)), lithium, or omeprazole/esomeprazole * Subjects less t…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Platelet aggregation

Timeframe: Blood will be drawn and aggregation measured at baseline (day 1) and every 14 days.

Trial details

NCT IDNCT06933056

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-09

Contact for this trial

Amanda Prieur

734-763-8824 famanda@med.umich.edu

View on ClinicalTrials.gov More Platelet Function and Reactivity Tests trials

Who can participate

Age range

18 Years – 79 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.