Primary HypercholesterolemiaPhase 3NCT07444762
Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of DW5421A/DW5421B Compared to Monotherapy of DW5421A
A Phase 3 study testing DW5421A and DW5421B in people with Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Daewon Pharmaceutical Co., Ltd. at 1 site in South Korea.
Trial summary
This is a multicenter, randomized, double-blind, active-controlled, parallel, phase III clinical trial to evaluate the efficacy and safety of combination therapy of DW5421A/DW5421B versus monotherapy of DW5421A in patients with primary hypercholesterolemia or mixed dyslipidemia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- What is being tested?
- DW5421A and DW5421B
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 184 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Apr 2025to 21 Oct 2025
- 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
- Subjects must meet all of the following criteria to be eligible for the study: [Screening]
- Male or female aged ≥19 years
- Subjects diagnosed with primary hypercholesterolemia or mixed dyslipidemia
- Subjects who satisfy both of the following criteria at Visit 1: (1) Triglyceride (TG) < 400 mg/dL; (2) Low-density lipoprotein cholesterol (LDL-C) ≤ 250 mg/dL
- At Visit 1, for subjects who are receiving hypercholesterolemia treatment, those who, in the investigator's judgment, can medically and appropriately discontinue their existing hypercholesterolemia treatment for the duration of the clinical trial.
- Subjects who voluntarily provided written informed consent to participate in this clinical trial.
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- [Randomization]
- If currently receiving hypercholesterolemia treatment, subjects who have undergone a washout period of at least 4 weeks prior to Visit 2.
- Subjects who have implemented TLC for at least 4 weeks prior to Visit 2 and have continued TLC through Visit 3.
- Subjects whose RIP IP compliance during the run-in period is between 70% and 130%.
- Subjects whose central laboratory test results at Visit 2 meet the criteria.
Who cannot join
- Subjects who meet any of the following conditions will not be eligible to participate in this clinical trial:
- Presence of any of the following medical histories or past surgical histories:
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- Acute arterial disease-related history (as of Visit 1, within the 12-week period preceding the visit including: Unstable angina, myocardial infarction, transient ischemic attack (TIA), cerebrovascular disease, coronary artery bypass graft (CABG), or percutaneous coronary intervention (PCI)) Exception: Subjects whose events occurred more than 12 weeks before Visit 1, have been adjudicated as cured, or are in a stable state (ex: managed with a stable drug dosage for at least 12 weeks prior to Visit 1) may be eligible.
- Hypersensitivity or prior exposure to the investigational product's active ingredients (pitavastatin, ezetimibe) or to any dyslipidemia-treating agents.
- History of fibromyalgia, myopathy, rhabdomyolysis, or other hereditary myopathies, or a family history of such conditions.
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- Severe heart failure (NYHA functional class III or IV).
- Any surgical or internal medical condition that could affect the absorption, distribution, metabolism, or excretion of the investigational drug (excluding uncomplicated appendectomy or hernia repair).
- A history of drug or alcohol abuse within 1 year prior to Visit 1.
- A history of malignancy (however, the following cases are eligible for participation):
- ① If at least 5 years have passed since completion of treatment for the tumor as of Visit 1, or if the subject is disease-free status.
- ② If at least 3 years have passed as of Visit 1 since complete excision of basal cell carcinoma or squamous cell carcinoma of the skin, curative resection of papillary thyroid carcinoma, or successful treatment of cervical carcinoma in situ.
- 2. Subjects with the following comorbidities:
- Uncontrolled hypertension (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg)
- Uncontrolled diabetes mellitus (HbA1c ≥ 9%)
- Uncontrolled thyroid dysfunction (TSH ≥ 1.5 × ULN)
- Hepatic dysfunction (AST or ALT ≥ 2 × ULN)
- Renal impairment (eGFR < 30 mL/min/1.73 m²)
- CK ≥ 2 × ULN
- Biliary obstruction or cholestasis
- Moderate hepatic disease or active liver disease
- Hypothyroidism
- Uncontrolled arrhythmia, as determined by the investigator
- Interstitial lung disease 3. Subjects who are administrating or are expected to administer concomitant medications prohibited by this clinical trial.
- 4. Subjects with chronic conditions requiring continuous use of systemic corticosteroids or immunosuppressants.
- 5. Subjects with secondary dyslipidemia due to conditions such as Cushing's syndrome, hypothyroidism, obstructive liver disease, or nephrotic syndrome.
- 6. Contraception and pregnancy:
- Pregnant or breastfeeding women, or those planning to become pregnant or breastfeed during the clinical trial period.
- Women of childbearing potential and men who do not agree to use appropriate contraception as specified in the protocol during the clinical trial period.
- 7. Subjects who have participated in another clinical trial and administered investigational product (or undergone an investigational medical device procedure) within 12 weeks prior to screening (however, enrollment may be permitted if participation was limited to an observational or retrospective study and, in the investigator's judgment, does not affect the efficacy or safety of this clinical trial).
- 8. Subjects deemed unsuitable for participation in this clinical trial at the investigator's discretion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of DW5421A/DW5421B Versus Monotherapy of DW5421A in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
This is a multicenter, randomized, double-blind, active-controlled, parallel, phase III clinical trial to evaluate the efficacy and safety of combination therapy of DW5421A/DW5421B versus monotherapy of DW5421A in patients with primary hypercholesterolemia or mixed dyslipidemia.
Read the detailed description
The primary objective is to demonstrate the superiority of combination therapy of DW5421A/DW5421B over monotherapy of DW5421A by comparing the change in LDL-C at week 8 after administration. Approximately equal numbers of patients were randomized in a 1:1 ratio to receive combination therapy of DW5421A/DW5421B or monotherapy of DW5421A for 8 weeks. Efficacy and safety assessments were conducted at week 4 and week 8.
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Being tested
- DW5421A, DW5421B Placebo, DW5421B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DW5421ADrug
IP is administered orally once daily at a consistent time each day, with or without food.
DW5421B PlaceboDrug
IP is administered orally once daily at a consistent time each day, with or without food.
DW5421BDrug
IP is administered orally once daily at a consistent time each day, with or without food.
| Study group | Role | What they receive |
|---|---|---|
| Combination Therapy of DW5421A/DW5421B | Experimental | Combination Therapy of DW5421A/DW5421B Receives: Drug: DW5421A; Drug: DW5421B |
| Monotherapy of DW5421A | Active comparator | Monotherapy of DW5421A Receives: Drug: DW5421A; Drug: DW5421B Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C change rate
LDL-C change rate at week 8 compared with baseline
Measured: week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start21 Apr 2025
- Primary completion21 Oct 2025
- Study completion21 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HypercholesterolemiaStudies of the same condition, open and under way.
- 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
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444762
- Sponsor's protocol ID
- DW5421-301
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 6 Mar 2026
- 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 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Active-controlled, Parallel, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of DW5421A/DW5421B Versus Monotherapy of DW5421A in Patients With Primary Hypercholesterolemia or Mixed Dyslipidemia
- ClinicalTrials.gov ID
- NCT07444762
- Acronym / sponsor ID
- DW5421-301
- Conditions
- Primary Hypercholesterolemia, Mixed Dyslipidemia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Daewon Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 21 Oct 2025 (actual)
- Study completion
- 21 Oct 2025 (actual)
- First posted
- 3 Mar 2026 (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 multicenter, randomized, double-blind, active-controlled, parallel, phase III clinical trial to evaluate the efficacy and safety of combination therapy of DW5421A/DW5421B versus monotherapy of DW5421A in patients with primary hypercholesterolemia or mixed dyslipidemia.
Detailed description
The primary objective is to demonstrate the superiority of combination therapy of DW5421A/DW5421B over monotherapy of DW5421A by comparing the change in LDL-C at week 8 after administration. Approximately equal numbers of patients were randomized in a 1:1 ratio to receive combination therapy of DW5421A/DW5421B or monotherapy of DW5421A for 8 weeks. Efficacy and safety assessments were conducted at week 4 and week 8.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy of DW5421A/DW5421B | Experimental | Drug: DW5421A, Drug: DW5421BCombination Therapy of DW5421A/DW5421B |
| Monotherapy of DW5421A | Active comparator | Drug: DW5421A, Drug: DW5421B PlaceboMonotherapy of DW5421A |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Subjects must meet all of the following criteria to be eligible for the study: [Screening]
- Male or female aged ≥19 years
- Subjects diagnosed with primary hypercholesterolemia or mixed dyslipidemia
- Subjects who satisfy both of the following criteria at Visit 1: (1) Triglyceride (TG) < 400 mg/dL; (2) Low-density lipoprotein cholesterol (LDL-C) ≤ 250 mg/dL
- At Visit 1, for subjects who are receiving hypercholesterolemia treatment, those who, in the investigator's judgment, can medically and appropriately discontinue their existing hypercholesterolemia treatment for the duration of the clinical trial.
Key exclusion criteria (31 listed)
- Subjects who meet any of the following conditions will not be eligible to participate in this clinical trial:
- <!-- -->
- ① If at least 5 years have passed since completion of treatment for the tumor as of Visit 1, or if the subject is disease-free status.
- ② If at least 3 years have passed as of Visit 1 since complete excision of basal cell carcinoma or squamous cell carcinoma of the skin, curative resection of papillary thyroid carcinoma, or successful treatment of cervical carcinoma in situ.
- 4. Subjects with chronic conditions requiring continuous use of systemic corticosteroids or immunosuppressants.
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 |
|---|---|---|
| DW5421AIP is administered orally once daily at a consistent time each day, with or without food. | Drug | Combination Therapy of DW5421A/DW5421B, Monotherapy of DW5421A |
| DW5421B PlaceboIP is administered orally once daily at a consistent time each day, with or without food. | Drug | Monotherapy of DW5421A |
| DW5421BIP is administered orally once daily at a consistent time each day, with or without food. | Drug | Combination Therapy of DW5421A/DW5421B |
Primary outcome
LDL-C change rate
Time frame: week 8
LDL-C change rate at week 8 compared with baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 DW5421A and DW5421B in people with Primary Hypercholesterolemia and Mixed Dyslipidemia, run by Daewon Pharmaceutical Co., Ltd. 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 11 inclusion and 31 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: finished, as of the sponsor's last update on 6 Mar 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LDL-C change rate (time frame: week 8). 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 6 Mar 2026.