Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506. (Atorf-YOOrct)

Phase 3 study to evaluate the effiacay and safety of YYC506

Study Overview

• Status: Recruiting
• Conditions: Dyslipidemias
• Intervention / Treatment: Drug: YYC506; Drug: Control Placebo; Drug: Control; Drug: YYC506 Placebo

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 Type: Interventional
• Enrollment (Anticipated): 554
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Seul Gi Ha, PM; Phone Number: 82-2-6202-7105; Email: sgha@yypharm.co.kr

Study Locations

• Korea, Republic of
  • Cheonju, Korea, Republic of
    • Recruiting
    • Chonbuk National University Hospital
  • Seongnam-si, Korea, Republic of
    • Not yet recruiting
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of
    • Not yet recruiting
    • Seoul National UniversityHospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Test Group; Take both YYC506 and Placebo(Control)	Drug: YYC506; YYC506; Drug: Control Placebo; Placebo
Active Comparator: Control Group; Take both Contral and Placebo(YYC506)	Drug: Control; Active control; Drug: YYC506 Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent change (%) of non-HDL-C from baseline	non HDL-C = TC - HDL-C	from baseline at 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yooyoung Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Hyo-soo Kim, Ph.D, Seoul National University Hospital; Principal Investigator: Hyo-soo Kim, Ph.D, Seoul National University Hospital; Principal Investigator: Soo Lim, Ph.D, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 29, 2021
• Primary Completion (Anticipated): May 31, 2021
• Study Completion (Anticipated): January 31, 2022

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Dyslipidemias
• Other Study ID Numbers: YYPCT_YYC506_301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No