Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy of DW5421A/DW5421B Compared to Monotherapy of DW5421A

NCT07444762 | Completed Phase 3

• 1 other identifier: DW5421-301
• Study Type: interventional
• Target: 184
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Hypercholesterolemia; Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• LDL-C change rate

  LDL-C change rate at week 8 compared with baseline

  week 8

Study Arms (2)

Combination Therapy of DW5421A/DW5421B

EXPERIMENTAL

Combination Therapy of DW5421A/DW5421B

Drug: DW5421A; Drug: DW5421B

Monotherapy of DW5421A

ACTIVE COMPARATOR

Monotherapy of DW5421A

Drug: DW5421A; Drug: DW5421B Placebo

Interventions

DW5421A DRUG

IP is administered orally once daily at a consistent time each day, with or without food.

Combination Therapy of DW5421A/DW5421B; Monotherapy of DW5421A

DW5421B Placebo DRUG

IP is administered orally once daily at a consistent time each day, with or without food.

Monotherapy of DW5421A

DW5421B DRUG

IP is administered orally once daily at a consistent time each day, with or without food.

Combination Therapy of DW5421A/DW5421B

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.
• \[Randomization\]
• 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.

You may not qualify if:

• 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.
• 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.
• \. Subjects with the following comorbidities:
• Uncontrolled hypertension (SBP ≥ 180 mmHg or DBP ≥ 110 mmHg)
• Uncontrolled diabetes mellitus (HbA1c ≥ 9%)

Sponsors & Collaborators

• Daewon Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 3, 2026
• Study Start: April 21, 2025
• Primary Completion: October 21, 2025
• Study Completion: October 21, 2025
• Last Updated: March 6, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)