A Clinical Trial to Evaluate the Efficacy and Safety of CKD-391 and CKD-331 in Patients With Primary Hypercholesterolemia

Chong Kun Dang

Status and phase: Enrolling; Phase 3

Conditions: Primary Hypercholesterolemia

Treatments: Drug: D086; Drug: Placebo (for CKD-331); Drug: Placebo (for D377); Drug: D377; Drug: Placebo (for D086); Drug: CKD-331

Study type: Interventional

Funder types: Industry

Identifiers

NCT05657574

A52_08HCL2217

Details and patient eligibility

About

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

Full 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.

Enrollment: 228 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Adults ≥ 19 years of age
• Primary hypercholesterolemia
• Patients willing and able to discontinue ongoing lipid-lowering therapy according to the opinion of the investigator

Exclusion criteria

• Secondary hypercholesterolemia

• Conditions / situations such as:

  1. Presence of any clinically significant uncontrolled endocrine/metabolic disease known to influence lipids levels
  2. 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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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228 participants in 4 patient groups

CKD-391

Experimental group

Description:

D377 + CKD-331 + placebo (for D086)

Treatment:

Drug: Placebo (for D086)

Drug: CKD-331

Drug: D377

CKD-331

Active Comparator group

Description:

CKD-331 + placebo (for D377) + placebo (for D086)

Treatment:

Drug: Placebo (for D086)

Drug: CKD-331

Drug: Placebo (for D377)

D377

Active Comparator group

Description:

D377 + placebo (for CKD-331) + placebo (for D086)

Treatment:

Drug: Placebo (for D086)

Drug: Placebo (for CKD-331)

Drug: D377

D086

Active Comparator group

Description:

D086 + placebo (for D377) + placebo (for CKD-331)

Treatment:

Drug: D086

Drug: Placebo (for CKD-331)

Drug: Placebo (for D377)