DyslipidemiasPhase 3NCT05809687

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

A Phase 3 study testing DKP21102_C, DKP21102_B and DKP21102_A in people with Dyslipidemias, run by Dongkwang Pharm. Co., Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Phase 3 study to evaluate the efficacy and safety of DKP21102_B Added on to DKP21102_A Compared with DKP21102_A Read more about this study

Who is it for?: Ages 19 years and older
Conditions the study is for: Dyslipidemias
What is being tested?: DKP21102_C, DKP21102_B and DKP21102_A
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 1 Jan 2025to 1 Dec 2027
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

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

Who cannot join

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.

About this study

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

Phase 3 study to evaluate the efficacy and safety of DKP21102_B Added on to DKP21102_A Compared with DKP21102_A

Read the 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.

Conditions: Dyslipidemias
Being tested: DKP21102_C, DKP21102_B, DKP21102_A
Medical subject headings: Dyslipidemias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DKP21102_CDrug
Placebo
DKP21102_BDrug
Treatment
DKP21102_ADrug
Active Control

Study groups in NCT05809687
Study group	Role	What they receive
Control group	Active comparator	DKP21102_A, DKP21102_C Receives: Drug: DKP21102_C; Drug: DKP21102_A
Treatment group	Experimental	DKP21102_A, DKP21102_B Receives: Drug: DKP21102_B; Drug: DKP21102_A

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent change (%) of non-HDL-C from baseline
non-HDL-C
Measured: from baseline at 12weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 20251 Dec 2027

First posted12 Apr 2023
Study start1 Jan 2025 (estimated)
Primary completion1 Dec 2026 (estimated)
Study completion1 Dec 2027 (estimated)

Why it stopped: The clinical trial was withdrawn due to a commercial decision.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for DyslipidemiasStudies 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05809687
Sponsor's protocol ID: DKP21102_301
Status last verified: Sep 2023
First submitted: 30 Mar 2023
Last updated: 24 Oct 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruitingPhase 2
Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
Dyslipidemia
Active, not recruitingObservational study
Impact of Dyslipidemia on Metabolic Health of Adults With Overweight/Obesity (IDOM): A Study at the San Raffaele Hospital Center for Metabolic Health
Dyslipidemia, Obesity & Overweight
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance

All Dyslipidemias trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluate Efficacy and Safety of DKP21102_B Added on to DKP21102_A Compared With DKP21102_A in Mixed Dyslipidemia Patients
ClinicalTrials.gov ID: NCT05809687
Acronym / sponsor ID: DKP21102_301
Conditions: Dyslipidemias
Phase: Phase 3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: The clinical trial was withdrawn due to a commercial decision.
Enrolment: 0 participants (actual)
Lead sponsor: Dongkwang Pharm. Co., Ltd.Industry (pharma, biotech, devices)
Study start: 1 Jan 2025 (estimated)
Primary completion: 1 Dec 2026 (estimated)
Study completion: 1 Dec 2027 (estimated)
First posted: 12 Apr 2023 (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.

Phase 3 study to evaluate the efficacy and safety of DKP21102_B Added on to DKP21102_A Compared with DKP21102_A

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Control group	Active comparator	Drug: DKP21102_C, Drug: DKP21102_ADKP21102_A, DKP21102_C
Treatment group	Experimental	Drug: DKP21102_B, Drug: DKP21102_ADKP21102_A, DKP21102_B

Who may qualify

Ages: 19 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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

Key exclusion criteria (3 listed)

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.

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
DKP21102_CPlacebo	Drug	Control group
DKP21102_BTreatment	Drug	Treatment group
DKP21102_AActive Control	Drug	Control group, Treatment group

Primary outcome

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

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
Individual participant dataSharing planned: No

Related trials for Dyslipidemias

Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Not yet recruitingPhase 4
Effectiveness and Tolerability of a Treat-to-Target Versus Fixed-Dose Statin Strategy in Patients With Atherosclerotic Cardiovascular Disease
Dyslipidemia, Hypercholesterolemia, Hypertriglyceridemia, Stroke (CVA) or TIA
Not yet recruitingPhase 2
Synbiotic as an Adjuvant Therapy for Dyslipidaemia and Gut Health
Dyslipidemia
Active, not recruitingObservational study
Impact of Dyslipidemia on Metabolic Health of Adults With Overweight/Obesity (IDOM): A Study at the San Raffaele Hospital Center for Metabolic Health
Dyslipidemia, Obesity & Overweight
RecruitingObservational study
Asprosin and miRNA Expression in Young Women With Metabolic Syndrome
Metabolic Syndrome, Insulin Resistance

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.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing DKP21102_C, DKP21102_B and DKP21102_A in people with Dyslipidemias, run by Dongkwang Pharm. Co., Ltd..

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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

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 was withdrawn before enrolling participants, so there are no results.

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?

Percent change (%) of non-HDL-C from baseline (time frame: from baseline at 12weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05809687.

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 24 Oct 2024; AzTrials last refreshed its copy on 6 Nov 2026.