Evaluating Apabetalone for Long-COVID in Diabetes Patients

A Phase II, Multi-centre Open Label Study to Assess the Efficacy and Safety of Oral Apabetalone With Background Dapagliflozin in Subjects With Long -COVID-19 (Post-COVID-19 Conditions) and Type 2 Diabetes Mellitus (T2DM)

This study is testing if adding a new medication called Apabetalone to the diabetes drug dapagliflozin can help people with Type 2 Diabetes who are dealing with Long-COVID symptoms feel better.

Quick facts

• Phase: Phase2; Phase3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Resverlogix Corp (Industry-sponsored)
• Drugs / interventions: prednisone
• Locations: 3 sites (Amman and 2 other locations)
• Trial ID: NCT06590324 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter clinical trial aims to evaluate the efficacy and safety of oral Apabetalone in combination with dapagliflozin for up to 12 weeks in patients with Type 2 Diabetes Mellitus (T2DM) who have experienced Long-COVID symptoms. Participants will receive Apabetalone alongside their existing dapagliflozin treatment, with a total of seven in-person clinic visits to monitor their progress. The study will assess various primary, secondary, and exploratory endpoints to determine the impact of the treatment on Long-COVID symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a documented diagnosis of Type 2 Diabetes and a history of Long-COVID symptoms lasting at least two months.

Not a fit: Patients without a diagnosis of Type 2 Diabetes or those who do not have Long-COVID symptoms may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly alleviate Long-COVID symptoms in patients with diabetes.

How similar studies have performed: While this approach is novel in the context of Long-COVID, similar studies have shown promise in treating post-viral syndromes.

Eligibility criteria

Inclusion Criteria:

1. Able and willing to provide written (signed and dated) informed consent before participation in the study, and to comply with scheduled visits, treatment plan, and other 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):

   1. Documented history of T2DM
   2. History of taking diabetes medication
   3. HbA1c ≥6.5% at Screening
4. Must be taking dapagliflozin as part of their diabetes medication, or, based on the Principal Investigator's judgment and indication, be willing to commence sponsor-provided dapagliflozin 10 mg daily for the duration of the study.
5. History of Long-COVID symptoms within 3 months from the onset of COVID-19 that have lasted for at least 2 months. Symptoms are listed in Long Covid Symptom Tool (LCST).
6. A Long Covid Impact Tool (LCIT) score of ≥ 30 at the Screening Visit and at Visit 2 (Day 1)
7. A negative SARS-CoV-2 test at the Screening Visit and at Visit 2 (Day 1)
8. Female subjects of childbearing potential and nonsterile male subjects with female partners of childbearing potential must agree to either remain abstinent or use highly effective non-hormonal methods of contraception throughout the study and at least 30 days after the last dose of study drug has been taken. Subjects must adhere to contraceptive use consistent with local regulations regarding the methods of contraception for those participating in clinical studies

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   Exclusion Criteria:
9. Subjects with chronic kidney disease (CKD) with an estimated glomerular filtration rate (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 hepatic encephalopathy, esophageal or gastric varices, active hepatitis, or prior porta-caval shunt procedure; chronic liver diseases such as primary biliary cholangitis, 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 the upper 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 strong inhibitors, 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 prior to screening (Visit 1).
15. Subject who have participated in a clinical study and received any investigational medication 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 enrollment at the Day 1 visit.
17. Subjects whose safety may be compromised by study participation or are not, in the opinion of the investigator, able or willing to comply with the protocol.

Where this trial is running

Amman and 2 other locations

• The Speciality Hospital — Amman, Jordan (Not_yet_recruiting)
• MNGHA- King Abdulaziz Hospital — Al Mubarraz, Saudi Arabia (Not_yet_recruiting)
• Al Kuwait Hospital — Dubai, Dubai, United Arab Emirates (Recruiting)

Study contacts

• Study coordinator: Omar Hamed

Conditions Post-Acute COVID-19 Syndrome