Socar Research

• The screening period was extended to accommodate potential scheduling challenges for MRI assessments, repeat laboratory assessments, and genetic testing for familial chylomicronemia syndrome.
• Eligibility criteria were revised to specify diabetes-related exclusions, permit participants with previously treated non-active hepatitis C infection, clarify malignancy and beta-blocker criteria, and exclude recent or anticipated major changes in triglyceride-lowering therapies.
• Women of childbearing potential were required to use highly effective contraception from informed consent until at least 17 weeks after the last study-drug dose, based on updated pharmacokinetic modeling.

These findings describe the trial, not the service provider’s performance or responsibility.

• Twenty-seven participants were enrolled across eight US sites between January 9, 2023, and March 4, 2024, with site enrollment ranging from 1 to 9 participants.
• France was not activated because regulatory and ethics approvals were received approximately 6 weeks before the last participant was enrolled.
• Important protocol deviations occurred in 9/27 participants (33.3%), including two inclusion-criteria deviations and two study procedures performed before informed consent.
• Five post-dose ECG timing deviations affected 3 participants.
• One participant missed the C-SSRS questionnaire, and one had repeat blood tests outside the required time window.

These findings describe the trial, not the service provider’s performance or responsibility.