Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.

Dyslipidemias Clinical Trial

— Atorf-YOOrct  

Official title:

Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04858308
• Other study ID #: YYPCT_YYC506_301
• Status: Recruiting
• Phase: Phase 3
• Start date: January 29, 2021
• Est. completion date: January 31, 2022

Study information

• Verified date: April 2021
• Source: Yooyoung Pharmaceutical Co., Ltd.
• Contact: Seul Gi Ha, PM
• Phone: 82-2-6202-7105
• Email: sgha[@]yypharm.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase 3 study to evaluate the effiacay and safety of YYC506

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 information / eligibility

• Status: Recruiting
• Enrollment: 554
• Est. completion date: January 31, 2022
• Est. primary completion date: May 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Dyslipidemias

Intervention

Drug:
• YYC506
YYC506
• Control
Active control
• YYC506 Placebo
Placebo
• Control Placebo
Placebo

Locations

Country	Name	City	State
Korea, Republic of	Chonbuk National University Hospital	Cheonju
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si
Korea, Republic of	Seoul National UniversityHospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yooyoung Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent change (%) of non-HDL-C from baseline	non HDL-C = TC - HDL-C	from baseline at 12 weeks
Secondary	Percent change (%) of non-HDL-C	non HDL-C = TC - HDL-C	from baseline at 4, 8, 14 weeks.
Secondary	Percent change (%) of lipid parameters	TC, HDL-C, LDL-C, TG	from baseline at 4, 8, 12, 24 weeks
Secondary	Percent change (%) of diabetes parameters	FBS, HbA1c, Insulin	from baseline at 4, 8, 12, 24 weeks