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

NCT06933056 | Recruiting Early Phase 1 FDA Drug

• 1 other identifier: HUM00267102
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Keywords

Sotagliflozin

Outcome Measures

Primary Outcomes (1)

• Platelet aggregation

  Measured from blood samples

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

Secondary Outcomes (4)

• Platelet granule secretion

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

• Total thrombus activation with T-TAS

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

• Thromboelastography (TEG)

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

• Platelet integrin activation

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

Study Arms (1)

Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents

EXPERIMENTAL

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.

Drug: Sotagliflozin (SOTA) followed by 3 drugs in a random order; Drug: Aspirin followed by 3 drugs in a random order; Drug: Clopidogrel followed by 3 drugs in a random order; Drug: Eliquis followed by 3 drugs in a random order

Interventions

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

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

Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents

Aspirin followed by 3 drugs in a random order DRUG

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

Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents

Clopidogrel followed by 3 drugs in a random order DRUG

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

Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents

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.

Also known as: Apixaban

Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• Lexicon Pharmaceuticals: collaborator

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Interventions

(2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; apixaban

Study Officials

• Michael Holinstat, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amanda Prieur

CONTACT

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

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pharmacology, Professor of Internal Medicine and Professor of Surgery

Model Details: administration of antiplatelet and anticoagulant drugs given to subjects in randomized order with washout period between drug administration.

Study Record Dates

• First Submitted: April 4, 2025
• First Posted: April 18, 2025
• Study Start: September 2, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)