Actively Recruiting
Phase 3 Study to Test the Safety and Effectiveness of AD-218 in Adults with Mixed Dyslipidemia
Led by Addpharma Inc. · Updated on 2025-02-05
520
Participants Needed
1
Research Sites
13 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of AD-218 in adults with mixed dyslipidemia. This Phase 3, randomized, double-blinded, active-controlled trial aims to compare AD-218 and AD-218A with their placebos for this condition. The study is sponsored by Addpharma Inc. and focuses on changes in lipid levels over a 12-week period. Participants will receive either AD-218 or AD-218A once daily by mouth for 12 weeks. The trial includes two active comparator groups, each receiving one of the study drugs. Both treatments are administered orally with daily dosing throughout the treatment period. During the study, participants will have their non-HDL cholesterol levels monitored at weeks 4, 8, and 12, along with other lipid panel measurements. The main outcome is the percent change in non-HDL cholesterol from baseline at week 12. Safety and efficacy assessments will continue through the study duration, with an extension phase also included. Total participation time aligns with the 12-week treatment and monitoring schedule.
CONDITIONS
Brief Title
A Study to Evaluate the Efficacy and Safety of AD-218
Research Team
S
Sarah Yoon
K
Kyu Chang Won, M.D., Ph.D
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