Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.
Phase 3
- Conditions
- Dyslipidemias
- Interventions
- Registration Number
- NCT04858308
- Lead Sponsor
- Yooyoung Pharmaceutical Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 554
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Test Group YYC506 Take both YYC506 and Placebo(Control) Control Group Control Take both Contral and Placebo(YYC506) Control Group YYC506 Placebo Take both Contral and Placebo(YYC506) Test Group Control Placebo Take both YYC506 and Placebo(Control)
- Primary Outcome Measures
Name Time Method Percent change (%) of non-HDL-C from baseline from baseline at 12 weeks non HDL-C = TC - HDL-C
- Secondary Outcome Measures
Name Time Method Percent change (%) of diabetes parameters from baseline at 4, 8, 12, 24 weeks FBS, HbA1c, Insulin
Percent change (%) of lipid parameters from baseline at 4, 8, 12, 24 weeks TC, HDL-C, LDL-C, TG
Percent change (%) of non-HDL-C from baseline at 4, 8, 14 weeks. non HDL-C = TC - HDL-C
Trial Locations
- Locations (3)
Chonbuk National University Hospital
🇰🇷Cheonju, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Korea, Republic of
Seoul National UniversityHospital
🇰🇷Seoul, Korea, Republic of