DyslipidemiasPhase 3NCT04772443
Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507
A Phase 3 study testing DWJ1506, DWJ1507 and DWC202011 in people with Dyslipidemias, run by Daewoong Pharmaceutical Co. LTD..
Trial summary
The purpose of this study is to determine the efficacy and safety of DWJ1506 and DWJ1507 in the patients with dyslipidemia. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- DWJ1506, DWJ1507 and DWC202011
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Feb 2021to Dec 2022
- 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
- Adults aged 19 years or over
- Patients with LDL-C levels ≤ 250 mg/dL, TG < 500 mg/dL
- Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study
Who cannot join
- Severe congestive hear failure
- Current active liver disease
- The use of prohibiterd concomitant therapies
- Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc.
- 6.Women who were of childbearing potential without contraception, pregnant, or breastfeeding
About this study
Official title: A Randomized, Double-blind, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507
The purpose of this study is to determine the efficacy and safety of DWJ1506 and DWJ1507 in the patients with dyslipidemia.
- Conditions
- Dyslipidemias
- Being tested
- DWJ1506, DWJ1507, DWC202011, DWJ1177
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DWJ1506Drug
DWJ1506
DWJ1507Drug
DWJ1507
DWC202011Drug
DWC202011
DWJ1177Drug
DWC202011
| Study group | Role | What they receive |
|---|---|---|
| DWJ1506 | Experimental | Not described Receives: Drug: DWJ1506 |
| DWJ1507 | Experimental | Not described Receives: Drug: DWJ1507 |
| DWC202011 | Active comparator | Not described Receives: Drug: DWC202011 |
| DWJ1177 | Active comparator | Not described Receives: Drug: DWJ1177 |
What is being measured
The primary outcome is the main question the study is designed to answer.
LDL-C levels at week 8
Change from baseline in LDL-C level at week 8 after administration of the IP
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study startFeb 2021 (estimated)
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
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.
- More trials run by Daewoong Pharmaceutical Co. LTD.The sponsor's other registered studies.
- 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
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772443
- Sponsor's protocol ID
- DW_DWJ1507301
- Status last verified
- Feb 2021
- First submitted
- 24 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507
- ClinicalTrials.gov ID
- NCT04772443
- Acronym / sponsor ID
- DW_DWJ1507301
- Conditions
- Dyslipidemias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Daewoong Pharmaceutical Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Feb 2021 (estimated)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 26 Feb 2021 (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.
The purpose of this study is to determine the efficacy and safety of DWJ1506 and DWJ1507 in the patients with dyslipidemia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| DWJ1506 | Experimental | Drug: DWJ1506 |
| DWJ1507 | Experimental | Drug: DWJ1507 |
| DWC202011 | Active comparator | Drug: DWC202011 |
| DWJ1177 | Active comparator | Drug: DWJ1177 |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adults aged 19 years or over
- Patients with LDL-C levels ≤ 250 mg/dL, TG < 500 mg/dL
- Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study
Key exclusion criteria (5 listed)
- Severe congestive hear failure
- Current active liver disease
- The use of prohibiterd concomitant therapies
- Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc.
- 6.Women who were of childbearing potential without contraception, pregnant, or breastfeeding
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 |
|---|---|---|
| DWJ1506DWJ1506 | Drug | DWJ1506 |
| DWJ1507DWJ1507 | Drug | DWJ1507 |
| DWC202011DWC202011 | Drug | DWC202011 |
| DWJ1177DWC202011 | Drug | DWJ1177 |
Primary outcome
LDL-C levels at week 8
Time frame: Week 8
Change from baseline in LDL-C level at week 8 after administration of the IP
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
- Individual participant dataSharing planned: Yes
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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 DWJ1506, DWJ1507 and DWC202011 in people with Dyslipidemias, run by Daewoong Pharmaceutical 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 3 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 26 Feb 2021. 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?
Results are not available in the source record.
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?
LDL-C levels at week 8 (time frame: Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Feb 2021.