RecruitingEarly Phase 1NCT06933056

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

Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study


Sponsor

University of Michigan

Enrollment

20 participants

Start Date

Sep 2, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 79 Years

Inclusion Criteria1

  • \-

Exclusion Criteria10

  • 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 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

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Interventions

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

400 mg/day SOTA Each drug will be given daily for 2 weeks.

DRUGAspirin followed by 3 drugs in a random order

81 mg/day Aspirin Each drug will be given daily for 2 weeks.

DRUGClopidogrel followed by 3 drugs in a random order

75 mg/day clopidogrel Each drug will be given daily for 2 weeks.

DRUGEliquis followed by 3 drugs in a random order

5 mg orally twice daily Eliquis Each drug will be given daily for 2 weeks.


Locations(1)

University of Michigan

Ann Arbor, Michigan, United States

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NCT06933056