Actively Recruiting
A Randomized, Double-blinded, Active-controlled, Multicenter Phase 3 Clinical Trial and Open-label Extension to Evaluate the Efficacy and Safety of AD-218 in Patients with Mixed Dyslipidemia
Led by Addpharma Inc. · Updated on 2025-02-05
520
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- A man or woman over 19 years old.
- Signed informed consent form before participation.
You will not qualify if you...
- History of Fibromyalgia or Myopathy with creatine kinase levels 2 times or more above the upper limit of normal.
- Other unspecified exclusion criteria applied.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take the study drug AD-218 or AD-218A once daily for 12 weeks.
Visits at baseline, week 4, week 8, and week 12
Trial Site Locations
Total: 1 location
1
Yeongnam University Hospital
Daegu, Nam-gu, South Korea, 42415
Actively Recruiting
Research Team
S
Sarah Yoon
K
Kyu Chang Won, M.D., Ph.D
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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