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

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

Study Overview

• Status: Recruiting
• Conditions: Platelet Function and Reactivity Tests
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Amanda Prieur; Phone Number: 734-763-8824; Email: famanda@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • University of Michigan
      • Contact: Amanda Prieur; Phone Number: 734-763-8824; Email: famanda@med.umich.edu
      • Principal Investigator: Michael Holinstat, PhD
      • Sub-Investigator: Ahmed Abdel-latif, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Drug: Sotagliflozin (SOTA) followed by 3 drugs in a random order; 400 mg/day SOTA Each drug will be given daily for 2 weeks.; Drug: Aspirin followed by 3 drugs in a random order; 81 mg/day Aspirin Each drug will be given daily for 2 weeks.; Drug: Clopidogrel followed by 3 drugs in a random order; 75 mg/day clopidogrel Each drug will be given daily for 2 weeks.; Drug: Eliquis followed by 3 drugs in a random order; 5 mg orally twice daily Eliquis Each drug will be given daily for 2 weeks.; Other Names: Apixaban

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet aggregation	Measured from blood samples	Blood will be drawn and aggregation measured at baseline (day 1) and every 14 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet granule secretion	Measured from blood samples	Blood will be drawn and granule secretion measured at baseline (day 1) and every 14 days.
Total thrombus activation with T-TAS	Measured from blood samples	Blood will be drawn and T-TAS measured at baseline (day 1) and every 14 days.
Thromboelastography (TEG)	Measured from blood samples	Blood will be drawn and thromboelastography measured at baseline (day 1) and every 14 days.
Platelet integrin activation	Measured from blood samples	Blood will be drawn and platelet integrin activation measured at baseline (day 1) and every 14 days.

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: Lexicon Pharmaceuticals
• Investigators: Principal Investigator: Michael Holinstat, PhD, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 4, 2025
• First Submitted That Met QC Criteria: April 10, 2025
• First Posted (Actual): April 18, 2025

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Sotagliflozin
• Additional Relevant MeSH Terms: Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Protease Inhibitors; Enzyme Inhibitors; Fibrin Modulating Agents; Antirheumatic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Antipyretics; Neurotransmitter Agents; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Fibrinolytic Agents; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Anticoagulants; Factor Xa Inhibitors; Antithrombins; Serine Proteinase Inhibitors; (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol; apixaban
• Other Study ID Numbers: HUM00267102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No