Phase 3 Trial to Evaluate the Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A

Evaluate Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A in Mixed Dyslipidemia Patients

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05809687

Enrollment

Registered

2023-04-12

Start date

2025-01-01

Completion date

2027-12-01

Last updated

2024-10-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemias

Brief summary

Phase 3 study to evaluate the efficacy and safety of DKP21102\_B Added on to DKP21102\_A Compared with DKP21102\_A

Detailed description

Phase 3 study to evaluate the efficacy and safety of DKP21102 in patients with mixed dyslipidemia where LDL-C is properly controlled but triglyceride and HDL-C levels are not regulated by DKP21102\_A alone.

Interventions

DRUGDKP21102_C

Placebo

DRUGDKP21102_B

Treatment

DRUGDKP21102_A

Active Control

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

Double-blind

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

Healthy volunteers

Inclusion criteria

* A man or woman over 19 years old. * Patients with coronary heart disease or risk of coronary heart disease

Exclusion criteria

* History of Unstable angina, myocardial infarction etc * Uncontrolled hypo-thyroidism (TSH≥1.5XULN), Diabetes(HbA1c ≥ 9.0%) * renal impairment (Creatinine clearance \< 60 mL/min) etc.

Design outcomes

Primary

Measure	Time frame	Description
Percent change (%) of non-HDL-C from baseline	from baseline at 12weeks	non-HDL-C

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026