Primary HypercholesterolemiaPhase 3NCT05657574
A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia
A Phase 3 study testing D377, CKD-331 and D086 in people with Primary Hypercholesterolemia, run by Chong Kun Dang Pharmaceutical at 1 site in South Korea.
Trial summary
This is a randomized, double-blind, multi-center, therapeutic confirmatory, phase 3 trial to evaluate the efficacy and safety of CKD-391 and CKD-331 in patients with primary hypercholesterolemia Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Primary Hypercholesterolemia
- What is being tested?
- D377, CKD-331 and D086
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteSouth Korea
- Study dates
- 24 Nov 2022to Jun 2023
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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
- Adults ≥ 19 years of age
- Primary hypercholesterolemia
- Patients willing and able to discontinue ongoing lipid-lowering therapy according to the opinion of the investigator
Who cannot join
- Secondary hypercholesterolemia
- Conditions / situations such as:
- Presence of any clinically significant uncontrolled endocrine/metabolic disease known to influence lipids levels
- Severe renal impairment or active liver disease
- History of hypersensitivity or allergies to investigational drugs or drug of similar chemical classes.
- History of drug abuse or alcoholism within 24 weeks before screening
- Any surgical or medical condition which might significantly affect the absorption, distribution, metabolism, or excretion of investigational drugs
- Patients who have been taken with other investigational drugs within 8 weeks before screening
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Asan Medical Center
Seoul
SeungHwan Lee, MD, +82-2-3010-4829, seungwlee@amc.seoul.kr
About this study
Official title: A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia
This is a randomized, double-blind, multi-center, therapeutic confirmatory, phase 3 trial to evaluate the efficacy and safety of CKD-391 and CKD-331 in patients with primary hypercholesterolemia
Read the detailed description
Participants were randomly assigned in a 1:1:1:1 ratio to the following groups: combination therapy of D377 and CKD-331, D377, CKD-331, and D086. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) for 8 weeks.
- Conditions
- Primary Hypercholesterolemia
- Being tested
- D377, CKD-331, D086, Placebo (for D377), Placebo (for CKD-331)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
D377Drug
oral, once daily, 8 weeks
CKD-331Drug
oral, once daily, 8 weeks
D086Drug
oral, once daily, 8 weeks
Placebo (for D377)Drug
oral, once daily, 8 weeks
Placebo (for CKD-331)Drug
oral, once daily, 8 weeks
Placebo (for D086)Drug
oral, once daily, 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| CKD-391 | Experimental | D377 + CKD-331 + placebo (for D086) Receives: Drug: D377; Drug: CKD-331; Drug: Placebo (for D086) |
| CKD-331 | Active comparator | CKD-331 + placebo (for D377) + placebo (for D086) Receives: Drug: CKD-331; Drug: Placebo (for D377); Drug: Placebo (for D086) |
| D377 | Active comparator | D377 + placebo (for CKD-331) + placebo (for D086) Receives: Drug: D377; Drug: Placebo (for CKD-331); Drug: Placebo (for D086) |
| D086 | Active comparator | D086 + placebo (for D377) + placebo (for CKD-331) Receives: Drug: D086; Drug: Placebo (for D377); Drug: Placebo (for CKD-331) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change
from Baseline at Week 8 of Low Density Lipoprotein Cholesterol (LDL-C)
Measured: Baseline, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2022
- Study start24 Nov 2022
- Primary completionJun 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary HypercholesterolemiaStudies of the same condition, open and under way.
- More trials run by Chong Kun Dang PharmaceuticalThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 228 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chong Kun Dang Pharmaceutical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- SeungHwan Lee, MD, Principal investigator, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05657574
- Sponsor's protocol ID
- A52_08HCL2217
- Status last verified
- Dec 2022
- First submitted
- 12 Dec 2022
- Last updated
- 20 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kim TO, Lee K, Cho JM, Yoon HJ, Park TH, Choi JH, Suh JW, Kim SY, Lim HS, Park JS, Cho DK, Park GM, Ahn SG, Shin S, Kwon SU, Kim DH, Lee SR, Sung JH, Park HC, Lee SW. Efficacy and safety of low-dose atorvastatin plus ezetimibe for primary hypercholesterolemia: A randomized, double-blind, multicenter phase 3 trial. Lipids. 2025 Sep;60(5):317-326. doi: 10.1002/lipd.12442. Epub 2025 Apr 18.
PubMed 40251695
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Therapeutic Confirmatory, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia
- ClinicalTrials.gov ID
- NCT05657574
- Acronym / sponsor ID
- A52_08HCL2217
- Conditions
- Primary Hypercholesterolemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 228 participants (estimated)
- Lead sponsor
- Chong Kun Dang PharmaceuticalIndustry (pharma, biotech, devices)
- Study start
- 24 Nov 2022 (actual)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 20 Dec 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.
This is a randomized, double-blind, multi-center, therapeutic confirmatory, phase 3 trial to evaluate the efficacy and safety of CKD-391 and CKD-331 in patients with primary hypercholesterolemia
Detailed description
Participants were randomly assigned in a 1:1:1:1 ratio to the following groups: combination therapy of D377 and CKD-331, D377, CKD-331, and D086. The patients are prescribed oral administration of the appropriate IP daily (3 tablets: actual medication and placebo) for 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CKD-391 | Experimental | Drug: D377, Drug: CKD-331, Drug: Placebo (for D086)D377 + CKD-331 + placebo (for D086) |
| CKD-331 | Active comparator | Drug: CKD-331, Drug: Placebo (for D377), Drug: Placebo (for D086)CKD-331 + placebo (for D377) + placebo (for D086) |
| D377 | Active comparator | Drug: D377, Drug: Placebo (for CKD-331), Drug: Placebo (for D086)D377 + placebo (for CKD-331) + placebo (for D086) |
| D086 | Active comparator | Drug: D086, Drug: Placebo (for D377), Drug: Placebo (for CKD-331)D086 + placebo (for D377) + placebo (for CKD-331) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults ≥ 19 years of age
- Primary hypercholesterolemia
- Patients willing and able to discontinue ongoing lipid-lowering therapy according to the opinion of the investigator
Key exclusion criteria (8 listed)
- Secondary hypercholesterolemia
- Conditions / situations such as:
- History of hypersensitivity or allergies to investigational drugs or drug of similar chemical classes.
- History of drug abuse or alcoholism within 24 weeks before screening
- Any surgical or medical condition which might significantly affect the absorption, distribution, metabolism, or excretion of investigational drugs
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 |
|---|---|---|
| D377oral, once daily, 8 weeks | Drug | CKD-391, D377 |
| CKD-331oral, once daily, 8 weeks | Drug | CKD-331, CKD-391 |
| D086oral, once daily, 8 weeks | Drug | D086 |
| Placebo (for D377)oral, once daily, 8 weeks | Drug | CKD-331, D086 |
| Placebo (for CKD-331)oral, once daily, 8 weeks | Drug | D086, D377 |
| Placebo (for D086)oral, once daily, 8 weeks | Drug | CKD-331, CKD-391, D377 |
Primary outcome
Percent Change
Time frame: Baseline, Week 8
from Baseline at Week 8 of Low Density Lipoprotein Cholesterol (LDL-C)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Derived from this study: PubMed 40251695Kim TO, Lee K, Cho JM, Yoon HJ, Park TH, Choi JH, Suh JW, Kim SY, Lim HS, Park JS, Cho DK, Park GM, Ahn SG, Shin S, Kwon SU, Kim DH, Lee SR, Sung JH, Park HC, Lee SW. Efficacy and safety of low-dose atorvastatin plus ezetimibe for primary hypercholesterolemia: A randomized, double-blind, multicenter phase 3 trial. Lipids. 2025 Sep;60(5):317-326. doi: 10.1002/lipd.12442. Epub 2025 Apr 18.
- 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. This study is not recruiting at the moment.
SeungHwan Lee, MD principal investigator
Asan Medical Center
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 D377, CKD-331 and D086 in people with Primary Hypercholesterolemia, run by Chong Kun Dang Pharmaceutical 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 3 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 20 Dec 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact SeungHwan Lee, MD (+82-2-3010-4829, seungwlee@amc.seoul.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change (time frame: Baseline, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05657574, which also lists 1 linked publication.
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 20 Dec 2022.