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NCT Number: NCT06933056

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

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

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Key information

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location status: Recruiting

Location contact

Ahmed Abdel-latif, MD, PhD

SUB_INVESTIGATOR

Amanda Prieur

CONTACT

[email protected]

734-763-8824

Michael Holinstat, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

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

Drug

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

Aspirin followed by 3 drugs in a random order

Drug

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

Clopidogrel followed by 3 drugs in a random order

Drug

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

Eliquis followed by 3 drugs in a random order

Drug

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

Other names: Apixaban

Primary outcomes

  1. Platelet aggregation

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

    Measured from blood samples

Secondary outcomes

  1. Platelet granule secretion

    Time frame: Blood will be drawn and granule secretion measured at baseline (day 1) and every 14 days.

    Measured from blood samples

  2. Total thrombus activation with T-TAS

    Time frame: Blood will be drawn and T-TAS measured at baseline (day 1) and every 14 days.

    Measured from blood samples

  3. Thromboelastography (TEG)

    Time frame: Blood will be drawn and thromboelastography measured at baseline (day 1) and every 14 days.

    Measured from blood samples

  4. Platelet integrin activation

    Time frame: Blood will be drawn and platelet integrin activation measured at baseline (day 1) and every 14 days.

    Measured from blood samples

Study contacts

Contact information is provided by the study sponsor or research team.

Amanda Prieur

CONTACT

[email protected]

734-763-8824

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Collaborators

  • Lexicon Pharmaceuticals

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 18, 2025
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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