| Eligibility |
Inclusion Criteria:
1. Provision of a signed and dated informed consent form (ICF).
2. Willing and able to comply with all study procedures for the duration of the study.
3. Male or female, =18 and =65 years of age.
4. Waist circumference =88 cm for female subjects or =102 cm for male subjects.
5. Fasting triglyceride >1.5 mmol/L for males and females.
6. An OGTT indicating impaired glucose tolerance as indicated by a 2-hour value >140
mg/dl or any value >200 mg/dl at any time point or a HbA1C level =5.7% but =6.4%.
Exclusion Criteria:
1. Female who is lactating at screening.
2. Female who is pregnant according to a pregnancy test at screening or prior to study
drug administration.
3. History of significant hypersensitivity to the study drug or excipients of the study
drug.
4. History of severe hypersensitivity reactions, such as anaphylaxis.
5. History of rare hereditary problems of galactose and/or lactose intolerance, lactase
deficiency or glucose-galactose malabsorption.
6. Positive screening results to HIV antigen and antibody, HBsAg or HCV tests.
7. Poses a significant suicidal risk as defined by C-SSRS score >Type 1 ideation at
screening.
8. Any clinically significant illness in the 28 days prior to study drug administration.
9. Presence or history of significant gastrointestinal, liver or kidney disease, or
surgery that may affect drug bioavailability.
10. History of significant and uncontrolled or unstable cardiovascular, pulmonary,
hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic
disease.
11. History of seizures (epilepsy) of any kind.
12. History of cranial surgery.
13. Presence of clinically significant ECG abnormalities at the screening visit, as
defined by medical judgment (maximum Fridericia's corrected QT interval [QTcF] 450
msec).
14. Any other clinically significant abnormalities in laboratory test results at screening
that would, in the opinion of an investigator, increase the subject's risk of
participation, jeopardize complete participation in the study, or compromise
interpretation of study data. Mild elevations in aspartate aminotransferase
(AST)/alanine aminotransferase (ALT) as may be seen in non-alcoholic fatty liver
disease (NAFLD) are not exclusionary. However, in these subjects, please follow the
hepatic safety section.
15. New prescription medication or changes to medication regimen within 90 days prior to
the first dose. (i.e., stable doses of anti-hypertensives etc. are allowed).
16. Use of the following medications for the time frames specified below, with the
exception of medications exempted by the Investigator on a case-by-case basis because
they are judged unlikely to affect the PK profile of the study drug or subject safety
(e.g., topical drug products without significant systemic absorption):
1. Any vaccination, including COVID-19 vaccine, within 14 days prior to the first
dose;
2. Depot injection or implant of any drug within 3 months prior to the first dose;
3. Any drugs known to induce or inhibit hepatic drug metabolism within 30 days prior
to the first dose.
4. Any drugs for the treatment of diabetes within 30 days prior to the first dose.
5. Any drugs prohibited by the Investigator on a case-by-case basis because they are
judged likely to affect the PD profile of the study drug or subject safety,
within at least 5 times the half-life of the drug and a minimum of 30 days prior
to the first dose.
17. Positive urine drug screen or alcohol breath test at screening.
18. History of significant alcohol abuse within 1 year prior to screening or regular use
of alcohol within 6 months prior to the screening visit (more than 14 units of alcohol
per week [1 unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]).
19. History of significant drug abuse within 1 year prior to screening, use of soft drugs
within 3 months prior to screening, marijuana within 1 month prior to screening, or
hard drugs (such as cocaine, phencyclidine [PCP], crack, opioid derivatives including
heroin, and amphetamine derivatives) within 1 year prior to screening.
20. Use of any cannabinoid containing product, including cannabis, within 1 month prior to
screening, by any route (e.g., oral, inhaled, topical).
21. Participation in a clinical research study involving the administration of an
investigational or marketed drug or device within 30 days (or a minimum of 5
half-lives, whichever is longer) prior to the first dose, administration of a
biological product in the context of a clinical research study within 90 days prior to
the first dose, or concomitant participation in an investigational study involving no
drug or device administration.
22. Donation of plasma within 7 days prior to dosing. Donation or loss of blood (excluding
volume drawn at screening) of 50 mL to 499 mL of blood within 30 days, or more than
499 mL within 56 days prior to the first dose.
23. Any reason, which in the opinion of the Investigator, would prevent the subject from
participating in the study.
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