DyslipidemiasPhase 3Atorf-YOOrctNCT04858308
Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.
A Phase 3 study testing YYC506 in people with Dyslipidemias, run by Yooyoung Pharmaceutical Co., Ltd. at 3 sites in South Korea.
Trial summary
Phase 3 study to evaluate the effiacay and safety of YYC506 Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Dyslipidemias
- What is being tested?
- YYC506
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 554 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 29 Jan 2021to 31 Jan 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 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- A man or woman over 19 years old.
- LDL-C properly controlled, TG, HDL-C is not properly controlled
- Sign on ICF prior to study participation
Who cannot join
- History of Fibromyalgia, Myopathy etc (CK ≥ 2XULN)
- Uncontrolled hypo-thyroidism (TSH≥1.5XULN)
- Severe renal impairemnet (Creainine clearance < 30mL/min) etc.
Trial locations and contacts
3 sites in 1 country.
South Korea3 sites, 3 recruiting
- Recruiting
Chonbuk National University Hospital
Cheonju
- Not yet recruiting
Seoul National University Bundang Hospital
Seongnam-si
- Not yet recruiting
Seoul National UniversityHospital
Seoul
About this study
Phase 3 study to evaluate the effiacay and safety of YYC506
Read the detailed description
Phase 3 study to evaluate the effiacay and safety of YYC506 in patients with complex dyslipidemia where LDL-C is properly controlled but TG and HDL-C levels are not regulated by Atorvastatin alone.
- Conditions
- Dyslipidemias
- Being tested
- YYC506, Control, YYC506 Placebo, Control Placebo
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YYC506Drug
YYC506
ControlDrug
Active control
YYC506 PlaceboDrug
Placebo
Control PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Active comparator | Take both YYC506 and Placebo(Control) Receives: Drug: YYC506; Drug: Control Placebo |
| Control Group | Active comparator | Take both Contral and Placebo(YYC506) Receives: Drug: Control; Drug: YYC506 Placebo |
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 = TC - HDL-C
Measured: from baseline at 12 weeks
Secondary outcomes (3)
Percent change (%) of non-HDL-C
non HDL-C = TC - HDL-C
Measured: from baseline at 4, 8, 14 weeks.
Percent change (%) of lipid parameters
TC, HDL-C, LDL-C, TG
Measured: from baseline at 4, 8, 12, 24 weeks
Percent change (%) of diabetes parameters
FBS, HbA1c, Insulin
Measured: from baseline at 4, 8, 12, 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start29 Jan 2021
- Primary completion31 May 2021 (estimated)
- Study completion31 Jan 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.
- 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
- Model description
- A multicenter, Double-blind, Randomized, Active-controlled, Double dummy, Parelle-group comparative.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 554 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hyo-soo Kim, Ph.D, Study chair, Seoul National University HospitalHyo-soo Kim, Ph.D, Principal investigator, Seoul National University HospitalSoo Lim, Ph.D, Principal investigator, Seoul National University Bundang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858308
- Sponsor's protocol ID
- YYPCT_YYC506_301
- Acronym
- Atorf-YOOrct
- Status last verified
- Apr 2021
- First submitted
- 20 Apr 2021
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.
- ClinicalTrials.gov ID
- NCT04858308
- Acronym / sponsor ID
- Atorf-YOOrct / YYPCT_YYC506_301
- Conditions
- Dyslipidemias
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 554 participants (estimated)
- Lead sponsor
- Yooyoung Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 29 Jan 2021 (actual)
- Primary completion
- 31 May 2021 (estimated)
- Study completion
- 31 Jan 2022 (estimated)
- First posted
- 26 Apr 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.
Phase 3 study to evaluate the effiacay and safety of YYC506
Detailed description
Phase 3 study to evaluate the effiacay and safety of YYC506 in patients with complex dyslipidemia where LDL-C is properly controlled but TG and HDL-C levels are not regulated by Atorvastatin alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A multicenter, Double-blind, Randomized, Active-controlled, Double dummy, Parelle-group comparative.
| Arm | Type | Receives |
|---|---|---|
| Test Group | Active comparator | Drug: YYC506, Drug: Control PlaceboTake both YYC506 and Placebo(Control) |
| Control Group | Active comparator | Drug: Control, Drug: YYC506 PlaceboTake both Contral and Placebo(YYC506) |
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- A man or woman over 19 years old.
- LDL-C properly controlled, TG, HDL-C is not properly controlled
- Sign on ICF prior to study participation
Key exclusion criteria (3 listed)
- History of Fibromyalgia, Myopathy etc (CK ≥ 2XULN)
- Uncontrolled hypo-thyroidism (TSH≥1.5XULN)
- Severe renal impairemnet (Creainine clearance < 30mL/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 |
|---|---|---|
| YYC506YYC506 | Drug | Test Group |
| ControlActive control | Drug | Control Group |
| YYC506 PlaceboPlacebo | Drug | Control Group |
| Control PlaceboPlacebo | Drug | Test Group |
Primary outcome
Percent change (%) of non-HDL-C from baseline
Time frame: from baseline at 12 weeks
non HDL-C = TC - HDL-C
3 secondary outcomes
Percent change (%) of non-HDL-C
Time frame: from baseline at 4, 8, 14 weeks.
Percent change (%) of lipid parameters
Time frame: from baseline at 4, 8, 12, 24 weeks
Percent change (%) of diabetes parameters
Time frame: from baseline at 4, 8, 12, 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Hyo-soo Kim, Ph.D study chair
Seoul National University Hospital
Hyo-soo Kim, Ph.D principal investigator
Seoul National University Hospital
Soo Lim, Ph.D principal investigator
Seoul National University Bundang Hospital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing YYC506 in people with Dyslipidemias, run by Yooyoung Pharmaceutical Co., Ltd. at 3 sites in South Korea.
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 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: status not confirmed, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Seul Gi Ha, PM (82-2-6202-7105, sgha@yypharm.co.kr), or a site near the patient. 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 12 weeks). 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 Apr 2021.