Evaluating the effectiveness and safety of AD-218 for mixed dyslipidemia
Official title: A Randomized, Double-blinded, Active-controlled, Multicenter Phase 3 Clinical Trial and Open-label, Extension Study to Evaluate the Efficacy and Safety of AD-218 in Patients with Mixed Dyslipidemia
Run by Addpharma Inc. · NCT05400317 · Data updated 2026-11-12
This study is testing if a new drug called AD-218 can help people with mixed dyslipidemia improve their cholesterol levels and overall health.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 520 (estimated) |
| Sponsor | Addpharma Inc. Industry-sponsored |
| Locations | 1 site (Daegu, Nam-gu) |
| Status | Recruiting |
| Started | July 27, 2022 |
| Main results expected | March 31, 2026 |
| Study ends | June 30, 2026 |
| Registry record updated | February 5, 2025 |
| Trial ID | NCT05400317 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 19 years old diagnosed with mixed dyslipidemia.
✕Probably not a fit
Patients with a history of fibromyalgia, myopathy, or elevated creatine kinase levels may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to assess the efficacy and safety of the drug AD-218 in patients with mixed dyslipidemia. Participants will receive either AD-218, AD-218A, or a placebo to determine the drug's impact on lipid levels and overall health. The study will involve individuals over 19 years old who meet specific inclusion criteria and will exclude those with certain medical histories. The trial is designed to provide robust data on the effectiveness of AD-218 in managing mixed dyslipidemia.
Why it matters
Potential benefit: If successful, this study could lead to a new treatment option for patients with mixed dyslipidemia, improving their lipid profiles and reducing cardiovascular risks.
How similar studies have gone: Other studies have shown promise in treating mixed dyslipidemia with similar pharmacological approaches, indicating potential for success.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * A man or woman over 19 years old. * Sign on ICF prior to study participation Exclusion Criteria: * History of Fibromyalgia, Myopathy etc (CK ≥ 2 X ULN) * Other exclusions applied
Where it's running
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Yeongnam University Hospital
Daegu, Nam-gu, South Korea Recruiting
Study contacts
- Principal investigator: Kyu Chang Won, M.D., Ph.D — Yeungnam University Hospital
- Study coordinator: Sarah Yoon
- Email: sryoon@addpharma.co.kr
- Phone: 82-031-891-5576
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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MWX203: a medicine for mixed dyslipidemia given alone or with Inclisiran
This phase 2 study tests MWX203 alone or with Inclisiran in adults with mixed dyslipidemia who don’t reach lipid goals on statins.
-
Obicetrapib vs. bempedoic acid for high-risk high cholesterol patients
This phase 3 study tests whether obicetrapib can lower LDL-C more than bempedoic acid in adults with primary non-familial hypercholesterolemia or mixed dyslipidemia who still have high LDL-C despite maximum tolerated therapy.
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Bempedoic Acid With Ezetiimibe in Adults with High Cholesterol or Mixed Dyslipidemia
This study tests bempedoic acid alone or with ezetimibe in real-world adults with primary hypercholesterolemia or mixed dyslipidemia to see how safe and effective it is in routine care.
-
Comparing the effects of two medications on healthy individuals
This study tests how two medications work in healthy people to see if one is safer or more effective than the other.
-
Evaluating the effectiveness and safety of a combination medication for cholesterol management
This study is testing a new combination medication for cholesterol management to see if it works better and is safe for people who need a change in their current cholesterol treatment.
-
Leqvio (inclisiran) post-marketing surveillance in Korea
This will see if Leqvio (inclisiran) is safe and lowers LDL cholesterol for adults in Korea with primary hypercholesterolemia or mixed dyslipidemia who are prescribed it in routine care.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.