NCT05809687

Brief Summary

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

Trial Health

45
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
17mo left

Started Jan 2025

Typical duration for phase_3

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress50%
Jan 2025Dec 2027

First Submitted

Initial submission to the registry

March 30, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 12, 2023

Completed
1.7 years until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 24, 2024

Status Verified

September 1, 2023

Enrollment Period

1.9 years

First QC Date

March 30, 2023

Last Update Submit

October 22, 2024

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

  • Percent change (%) of non-HDL-C from baseline

    non-HDL-C

    from baseline at 12weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

DKP21102\_A, DKP21102\_C

Drug: DKP21102_CDrug: DKP21102_A

Treatment group

EXPERIMENTAL

DKP21102\_A, DKP21102\_B

Drug: DKP21102_BDrug: DKP21102_A

Interventions

DKP21102_CDRUG

Placebo

Control group
DKP21102_BDRUG

Treatment

Treatment group
DKP21102_ADRUG

Active Control

Control groupTreatment group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Double-blind
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2023

First Posted

April 12, 2023

Study Start

January 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

October 24, 2024

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share