Recruiting
Early Phase 1

Sotagliflozin vs. FDA-Approved Drugs

Sponsor:

University of Michigan

Code:

NCT06933056

Conditions

Platelet Function and Reactivity Tests

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

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

Aspirin followed by 3 drugs in a random order

Clopidogrel followed by 3 drugs in a random order

Eliquis followed by 3 drugs in a random order

Study Details

Brief 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.

Conditions

Platelet Function and Reactivity Tests

Study ID

NCT06933056

Start date

Sep 2, 2025

Status verified date

Sep, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents

Platelet responsiveness will be assessed in the blood from subjects administered sotagliflozin, aspirin, clopidogrel, or apixaban in randomized order given as a single drug administration.

Interventions

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

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

Aspirin followed by 3 drugs in a random order

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

Clopidogrel followed by 3 drugs in a random order

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

Eliquis followed by 3 drugs in a random order

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

Primary outcome measure

  • Platelet aggregation [ Time Frame: Blood will be drawn and aggregation measured at baseline (day 1) and every 14 days. ]

Central Contacts and Locations

Central contacts

Amanda Prieur

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

Locations

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

Contacts

Amanda Prieur

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

Principal Investigator:

Michael Holinstat, PhD

More Information

Sponsor

University of Michigan

Last update posted

Sep 15, 2025

Last verified

Sep, 2025

Keywords

  • Sotagliflozin

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Michigan on 2025-09-15.