Mixed DyslipidemiaPhase 3NCT05400317
A Study to Evaluate the Efficacy and Safety of AD-218
A Phase 3 study testing AD-218 and AD-218A in people with Mixed Dyslipidemia, run by Addpharma Inc. at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of AD-218 Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Mixed Dyslipidemia
- What is being tested?
- AD-218 and AD-218A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 520 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Jul 2022to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A man or woman over 19 years old.
- Sign on ICF prior to study participation
Who cannot join
- History of Fibromyalgia, Myopathy etc (CK ≥ 2 X ULN)
- Other exclusions applied
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kyu Chang Won, M.D., Ph.D contact
South Korea1 site, 1 recruiting
- Recruiting
Yeongnam University Hospital
Daegu, Nam-gu, 42415
Kyu Chang Won, M.D., Ph.D
About this study
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
The purpose of this study is to evaluate the efficacy and safety of AD-218
Read the detailed description
Condition or disease : Mixed Dyslipidemia Treatment Drug : AD-218, AD-218A, Placebo of AD-218, Placebo of AD-218A
- Conditions
- Mixed Dyslipidemia
- Being tested
- AD-218, AD-218A
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AD-218Drug
PO, Once daily(QD), 12weeks
AD-218ADrug
PO, Once daily(QD), 12weeks
| Study group | Role | What they receive |
|---|---|---|
| Active Comparator : Test group | Experimental | AD-218 Receives: Drug: AD-218 |
| Active Comparator : Control group | Active comparator | AD-218A Receives: Drug: AD-218A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change (%) of non-HDL-C from baseline at week 12
non-HDL-C at week 12 compared AD-218 with AD-218A
Measured: from baseline at 12 weeks
Secondary outcomes (2)
Percent change (%) of non-HDL-C from baseline at week 4, 8
non-HDL-C at week 4,8 compared AD-218 with AD-218A
Measured: from baseline at week 4,8
Percent change (%) of Lipid panel from baseline at week 4, 8, 12
Lipid panel at week 4, 8, 12 compared AD-218 with AD-218A
Measured: from baseline at week 4, 8, 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start27 Jul 2022
- Primary completion31 Mar 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed DyslipidemiaStudies of the same condition, open and under way.
- More trials run by Addpharma Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 520 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Addpharma Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kyu Chang Won, M.D., Ph.D, Principal investigator, Yeungnam University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05400317
- Sponsor's protocol ID
- AD-218P3
- Status last verified
- Feb 2025
- First submitted
- 27 May 2022
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05400317
- Acronym / sponsor ID
- AD-218P3
- Conditions
- Mixed Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 520 participants (estimated)
- Lead sponsor
- Addpharma Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Jul 2022 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the efficacy and safety of AD-218
Detailed description
Condition or disease : Mixed Dyslipidemia Treatment Drug : AD-218, AD-218A, Placebo of AD-218, Placebo of AD-218A
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Comparator : Test group | Experimental | Drug: AD-218AD-218 |
| Active Comparator : Control group | Active comparator | Drug: AD-218AAD-218A |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- A man or woman over 19 years old.
- Sign on ICF prior to study participation
Key exclusion criteria (2 listed)
- History of Fibromyalgia, Myopathy etc (CK ≥ 2 X ULN)
- Other exclusions applied
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AD-218PO, Once daily(QD), 12weeks | Drug | Active Comparator : Test group |
| AD-218APO, Once daily(QD), 12weeks | Drug | Active Comparator : Control group |
Primary outcome
Percent change (%) of non-HDL-C from baseline at week 12
Time frame: from baseline at 12 weeks
non-HDL-C at week 12 compared AD-218 with AD-218A
2 secondary outcomes
Percent change (%) of non-HDL-C from baseline at week 4, 8
Time frame: from baseline at week 4,8
Percent change (%) of Lipid panel from baseline at week 4, 8, 12
Time frame: from baseline at week 4, 8, 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kyu Chang Won, M.D., Ph.D contact
Kyu Chang Won, M.D., Ph.D principal investigator
Yeungnam University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing AD-218 and AD-218A in people with Mixed Dyslipidemia, run by Addpharma Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Yoon (82-031-891-5576, sryoon@addpharma.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change (%) of non-HDL-C from baseline at week 12 (time frame: from baseline at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.