A Study of Apabetalone in Subjects With Long -COVID

Inclusion Criteria:

1. Able and willing to provide written (signed and dated) informed consent beforeparticipation in the study, and to comply with scheduled visits, treatment plan, andother study-related procedures to complete the study.

2. Male or female subjects who are ≥ 18 years of age at Screening.

3. Documented diagnosis of T2DM (one or more of the following criteria must be met):

4. Documented history of T2DM

5. History of taking diabetes medication

6. HbA1c ≥6.5% at Screening

7. Must be taking dapagliflozin as part of their diabetes medication, or, based on thePrincipal Investigator's judgment and indication, be willing to commencesponsor-provided dapagliflozin 10 mg daily for the duration of the study.

8. History of Long-COVID symptoms within 3 months from the onset of COVID-19 that havelasted for at least 2 months. Symptoms are listed in Long Covid Symptom Tool (LCST).

9. A Long Covid Impact Tool (LCIT) score of ≥ 30 at the Screening Visit and at Visit 2 (Day 1)

10. A negative SARS-CoV-2 test at the Screening Visit and at Visit 2 (Day 1)

11. Female subjects of childbearing potential and nonsterile male subjects with femalepartners of childbearing potential must agree to either remain abstinent or usehighly effective non-hormonal methods of contraception throughout the study and atleast 30 days after the last dose of study drug has been taken. Subjects must adhereto contraceptive use consistent with local regulations regarding the methods ofcontraception for those participating in clinical studies

•   Exclusion Criteria:
  

9. Subjects with chronic kidney disease (CKD) with an estimated glomerular filtrationrate (eGFR) <25 mL/min/1.73 m2

10. New York Heart Association Class IV congestive heart failure

11. Evidence of cirrhosis from liver imaging or biopsy, a history of hepaticencephalopathy, esophageal or gastric varices, active hepatitis, or priorporta-caval shunt procedure; chronic liver diseases such as primary biliarycholangitis, untreated hemochromatosis, and primary sclerosing cholangitis

12. Subject meets any of the following laboratory criteria at Screening:

• Alanine transaminase (ALT) or aspartate transaminase (AST) values > 1.5x theupper limit of normal (ULN)

• Total bilirubin >1.5 × ULN.

• Evidence of an active hepatitis B virus or hepatitis C virus infection

• History of a positive test for human immunodeficiency virus (HIV)

13. Subjects taking concomitant cytochrome P450 3A4 strong inducers and/or stronginhibitors, or corticosteroid use >10 mg daily prednisone or equivalent.

14. Subjects who have received a COVID-19 vaccine or booster in the last 30 days priorto screening (Visit 1).

15. Subject who have participated in a clinical study and received any investigationalmedication within the last 30 days prior to screening (Visit 1).

16. Female subjects who are pregnant, planning to get pregnant, lactating/breastfeeding,or has a positive urine pregnancy test at the Screening Visit or prior to enrollmentat the Day 1 visit.

17. Subjects whose safety may be compromised by study participation or are not, in theopinion of the investigator, able or willing to comply with the protocol.