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)

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
SUMMARY

This is an open label, multicentre, phase II clinical trial that aims to assess the efficacy and safety of oral Apabetalone with background dapagliflozin for up to 12 weeks in T2DM patients with a history of probable or confirmed SARS-CoV-2 infection, with symptoms within 3 months from the onset of COVID-19 that last for at least 2 months and cannot be explained by an alternative diagnosis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

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

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

‣ Documented history of T2DM

⁃ History of taking diabetes medication

⁃ HbA1c ≥6.5% at Screening

• 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.

• 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).

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

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

• 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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Locations
Other Locations
Jordan
The Speciality Hospital
NOT_YET_RECRUITING
Amman
Saudi Arabia
MNGHA- King Abdulaziz Hospital
NOT_YET_RECRUITING
Al Mubarraz
United Arab Emirates
Al Kuwait Hospital
RECRUITING
Dubai
Contact Information
Primary
Omar Hamed
Omar.Hamed@pdc-cro.com
(+971)429704901
Backup
Moaz Rashad
moaz.rashad@pdc-cro.com
(+971)581154600
Time Frame
Start Date: 2025-04-15
Estimated Completion Date: 2026-03-30
Participants
Target number of participants: 200
Treatments
Experimental: apabetalone
apabetalone selectively binds to the second bromodomain \[BD2\] of bromodomain extra terminal (BET) proteins, curbing the transcription of multiple disease associated genes that promote vascular inflammation, complement, acute phase response (APR), fibrosis, dyslipidemia, and vascular calcification.
Related Therapeutic Areas
Sponsors
Leads: Resverlogix Corp

This content was sourced from clinicaltrials.gov