Back to resultsPhase 3 Trial to Evaluate the Efficacy and Safety of YYC506. (Atorf-YOOrct)
Primary Purpose
Dyslipidemias
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YYC506
Control
YYC506 Placebo
Control Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Dyslipidemias
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- History of Fibromyalgia, Myopathy etc (CK ≥ 2XULN)
- Uncontrolled hypo-thyroidism (TSH≥1.5XULN)
- Severe renal impairemnet (Creainine clearance < 30mL/min) etc.
Sites / Locations
- Chonbuk National University HospitalRecruiting
- Seoul National University Bundang Hospital
- Seoul National UniversityHospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Test Group
Control Group
Arm Description
Take both YYC506 and Placebo(Control)
Take both Contral and Placebo(YYC506)
Outcomes
Primary Outcome Measures
Percent change (%) of non-HDL-C from baseline
non HDL-C = TC - HDL-C
Secondary Outcome Measures
Percent change (%) of non-HDL-C
non HDL-C = TC - HDL-C
Percent change (%) of lipid parameters
TC, HDL-C, LDL-C, TG
Percent change (%) of diabetes parameters
FBS, HbA1c, Insulin
Full Information
NCT ID
NCT04858308
First Posted
April 20, 2021
Last Updated
April 21, 2021
Sponsor
Yooyoung Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT04858308
Brief Title
Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.
Acronym
Atorf-YOOrct
Official Title
Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 29, 2021 (Actual)
Primary Completion Date
May 31, 2021 (Anticipated)
Study Completion Date
January 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yooyoung Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemias
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
A multicenter, Double-blind, Randomized, Active-controlled, Double dummy, Parelle-group comparative.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind.
Allocation
Randomized
Enrollment
554 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Test Group
Arm Type
Active Comparator
Arm Description
Take both YYC506 and Placebo(Control)
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Take both Contral and Placebo(YYC506)
Intervention Type
Drug
Intervention Name(s)
YYC506
Intervention Description
YYC506
Intervention Type
Drug
Intervention Name(s)
Control
Intervention Description
Active control
Intervention Type
Drug
Intervention Name(s)
YYC506 Placebo
Intervention Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Control Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percent change (%) of non-HDL-C from baseline
Description
non HDL-C = TC - HDL-C
Time Frame
from baseline at 12 weeks
Secondary Outcome Measure Information:
Title
Percent change (%) of non-HDL-C
Description
non HDL-C = TC - HDL-C
Time Frame
from baseline at 4, 8, 14 weeks.
Title
Percent change (%) of lipid parameters
Description
TC, HDL-C, LDL-C, TG
Time Frame
from baseline at 4, 8, 12, 24 weeks
Title
Percent change (%) of diabetes parameters
Description
FBS, HbA1c, Insulin
Time Frame
from baseline at 4, 8, 12, 24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
History of Fibromyalgia, Myopathy etc (CK ≥ 2XULN)
Uncontrolled hypo-thyroidism (TSH≥1.5XULN)
Severe renal impairemnet (Creainine clearance < 30mL/min) etc.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Seul Gi Ha, PM
Phone
82-2-6202-7105
Email
sgha@yypharm.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hyo-soo Kim, Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hyo-soo Kim, Ph.D
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Soo Lim, Ph.D
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chonbuk National University Hospital
City
Cheonju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Seoul National UniversityHospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.
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