Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506. | NCT04858308

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

NCT04858308

Sponsor

Yooyoung Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Apr 26, 2021Actual

Enrollment

554Estimated

Phase

Phase 3

Conditions

Dyslipidemias

Interventions

YYC506
Control
YYC506 Placebo
Control Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 29, 2021Actual

Primary Completion Date

May 31, 2021Estimated

Completion Date

Jan 31, 2022Estimated

First Submitted Date

Apr 20, 2021

First Submission Date that Met QC Criteria

Apr 21, 2021

First Posted Date

Apr 26, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 21, 2021

Last Update Posted Date

Apr 26, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

554Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Test Group	Active Comparator	Take both YYC506 and Placebo(Control)	Drug: YYC506 Drug: Control Placebo
Control Group	Active Comparator	Take both Contral and Placebo(YYC506)	Drug: Control Drug: YYC506 Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YYC506	Drug	YYC506	Test Group
Control

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Seul Gi Ha, PM	Contact	82-2-6202-7105		sgha@yypharm.co.kr

Overall Officials

Name	Affiliation	Role
Hyo-soo Kim, Ph.D	Seoul National University Hospital	Study Chair
Hyo-soo Kim, Ph.D	Seoul National University Hospital	Principal Investigator
Soo Lim, Ph.D

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Chonbuk National University Hospital	Recruiting	Cheonju			South Korea
Seoul National University Bundang Hospital

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided