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

Last updated: September 8, 2025
Sponsor: University of Michigan
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

Aspirin followed by 3 drugs in a random order

Eliquis followed by 3 drugs in a random order

Sotagliflozin (SOTA) followed by 3 drugs in a random order

Clinical Study ID

NCT06933056
HUM00267102
  • Ages 18-79
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Exclusion

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, orsubjects taking a ketogenic diet

  • Women who self-identify as being pregnant or who are planning to become pregnantduring the 14 week study will be excluded from the study, as are those who arebreastfeeding (women enrolled in the study will be given a urine pregnancy test atthe start of each drug administration period to confirm pregnancy status)

  • Subjects with hypersensitivity to aspirin, clopidogrel, apixaban, or sotagliflozinare excluded

  • have active bleeding, or who have who have a history of balanitis orbalanoposthitis, genital mycotic infections, or a planned elective surgical/dentalprocedure 1 month prior to or following completion of study

  • Subjects who have taken Non-Steroidal Anti-Inflammatory Drugs (NSAIDS; examples ofNSAIDS are Ibuprofen (Advil, Motrin) and Naproxen (Aleve)) or aspirin within 7 daysprior 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 than or equal to 60 kg will be excluded

  • Subjects with a creatinine greater than or equal to 1.5 mg/dl will be excluded

Study Design

Total Participants: 20
Treatment Group(s): 4
Primary Treatment: Aspirin followed by 3 drugs in a random order
Phase: 1
Study Start date:
September 02, 2025
Estimated Completion Date:
September 30, 2026

Connect with a study center

  • University of Michigan

    Ann Arbor, Michigan 48109
    United States

    Site Not Available

  • University of Michigan

    Ann Arbor 4984247, Michigan 5001836 48109
    United States

    Active - Recruiting

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