Platelet Function and Reactivity TestsEarly Phase 1NCT06933056
Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs
A Early Phase 1 study testing Sotagliflozin (SOTA) followed by 3 drugs in a random order, Aspirin followed by 3 drugs in a random order and Clopidogrel followed by 3 drugs in a random order in people with Platelet Function and Reactivity Tests, run by University of Michigan at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Platelet Function and Reactivity Tests
- What is being tested?
- Sotagliflozin (SOTA) followed by 3 drugs in a random order, Aspirin followed by 3 drugs in a random order and Clopidogrel followed by 3 drugs in a random order
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Sep 2025to 19 Oct 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- -
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Platelet Function and Reactivity Tests
- Being tested
- 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
- Keywords
- Sotagliflozin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sotagliflozin (SOTA) followed by 3 drugs in a random orderDrug
400 mg/day SOTA Each drug will be given daily for 2 weeks.
Aspirin followed by 3 drugs in a random orderDrug
81 mg/day Aspirin Each drug will be given daily for 2 weeks.
Clopidogrel followed by 3 drugs in a random orderDrug
75 mg/day clopidogrel Each drug will be given daily for 2 weeks.
Eliquis followed by 3 drugs in a random orderDrug
Also called Apixaban
5 mg orally twice daily Eliquis Each drug will be given daily for 2 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet aggregation
Measured from blood samples
Measured: Blood will be drawn and aggregation measured at baseline (day 1) and every 14 days.
Secondary outcomes (4)
Platelet granule secretion
Measured from blood samples
Measured: 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
Measured: Blood will be drawn and T-TAS measured at baseline (day 1) and every 14 days.
Thromboelastography (TEG)
Measured from blood samples
Measured: Blood will be drawn and thromboelastography measured at baseline (day 1) and every 14 days.
Platelet integrin activation
Measured from blood samples
Measured: Blood will be drawn and platelet integrin activation measured at baseline (day 1) and every 14 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start2 Sep 2025
- Primary completion19 Oct 2026
- Study completion19 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Platelet Function and Reactivity TestsStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- administration of antiplatelet and anticoagulant drugs given to subjects in randomized order with washout period between drug administration.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Lexicon Pharmaceuticals
- Responsible party
- Principal investigator, Michael Holinstat, University of Michigan
- Investigators
- Michael Holinstat, PhD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933056
- Sponsor's protocol ID
- HUM00267102
- Status last verified
- Oct 2026
- First submitted
- 4 Apr 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Antiplatelet Effects of Sotagliflozin to FDA-approved Antiplatelet Drugs: an Interventional Study
- ClinicalTrials.gov ID
- NCT06933056
- Acronym / sponsor ID
- HUM00267102
- Conditions
- Platelet Function and Reactivity Tests
- Keywords
- Sotagliflozin
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Lexicon Pharmaceuticals
- Study start
- 2 Sep 2025 (actual)
- Primary completion
- 19 Oct 2026 (actual)
- Study completion
- 19 Oct 2026 (actual)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- administration of antiplatelet and anticoagulant drugs given to subjects in randomized order with washout period between drug administration.
| Arm | Type | Receives |
|---|---|---|
| Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents | Experimental | 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 orderPlatelet responsiveness will be assessed in the blood from subjects administered sotagliflozin, aspirin, clopidogrel, or apixaban in randomized order given as a single drug administration. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- -
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sotagliflozin (SOTA) followed by 3 drugs in a random order400 mg/day SOTA Each drug will be given daily for 2 weeks. | Drug | Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents |
| Aspirin followed by 3 drugs in a random order81 mg/day Aspirin Each drug will be given daily for 2 weeks. | Drug | Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents |
| Clopidogrel followed by 3 drugs in a random order75 mg/day clopidogrel Each drug will be given daily for 2 weeks. | Drug | Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents |
| Eliquis followed by 3 drugs in a random orderAlso: Apixaban5 mg orally twice daily Eliquis Each drug will be given daily for 2 weeks. | Drug | Platelet function in healthy subjects administered sotagliflozin vs. antiplatelet agents |
Primary outcome
Platelet aggregation
Time frame: Blood will be drawn and aggregation measured at baseline (day 1) and every 14 days.
Measured from blood samples
4 secondary outcomes
Platelet granule secretion
Time frame: Blood will be drawn and granule secretion measured at baseline (day 1) and every 14 days.
Total thrombus activation with T-TAS
Time frame: Blood will be drawn and T-TAS measured at baseline (day 1) and every 14 days.
Thromboelastography (TEG)
Time frame: Blood will be drawn and thromboelastography measured at baseline (day 1) and every 14 days.
Platelet integrin activation
Time frame: Blood will be drawn and platelet integrin activation measured at baseline (day 1) and every 14 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Holinstat, PhD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Sotagliflozin (SOTA) followed by 3 drugs in a random order, Aspirin followed by 3 drugs in a random order and Clopidogrel followed by 3 drugs in a random order in people with Platelet Function and Reactivity Tests, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Platelet aggregation (time frame: Blood will be drawn and aggregation measured at baseline (day 1) and every 14 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2026.