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

Sponsor
Yooyoung Pharmaceutical Co., Ltd. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04858308
Collaborator
(none)
554
Enrollment
3
Locations
2
Arms
12.1
Anticipated Duration (Months)
184.7
Patients Per Site
15.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Phase 3 study to evaluate the effiacay and safety of YYC506

Condition or Disease Intervention/Treatment Phase
Phase 3

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 Design

Study Type:
Interventional
Anticipated Enrollment :
554 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
A multicenter, Double-blind, Randomized, Active-controlled, Double dummy, Parelle-group comparative.A multicenter, Double-blind, Randomized, Active-controlled, Double dummy, Parelle-group comparative.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Double-blind.
Primary Purpose:
Treatment
Official Title:
Phase 3 Trial to Evaluate the Efficacy and Safety of YYC506.
Actual Study Start Date :
Jan 29, 2021
Anticipated Primary Completion Date :
May 31, 2021
Anticipated Study Completion Date :
Jan 31, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Percent change (%) of non-HDL-C from baseline [from baseline at 12 weeks]

    non HDL-C = TC - HDL-C

Secondary Outcome Measures

  1. Percent change (%) of non-HDL-C [from baseline at 4, 8, 14 weeks.]

    non HDL-C = TC - HDL-C

  2. Percent change (%) of lipid parameters [from baseline at 4, 8, 12, 24 weeks]

    TC, HDL-C, LDL-C, TG

  3. Percent change (%) of diabetes parameters [from baseline at 4, 8, 12, 24 weeks]

    FBS, HbA1c, Insulin

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chonbuk National University Hospital Cheonju Korea, Republic of
2 Seoul National University Bundang Hospital Seongnam-si Korea, Republic of
3 Seoul National UniversityHospital Seoul Korea, Republic of

Sponsors and Collaborators

  • 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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Yooyoung Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT04858308
Other Study ID Numbers:
  • YYPCT_YYC506_301
First Posted:
Apr 26, 2021
Last Update Posted:
Apr 26, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Dyslipidemias

Study Results

No Results Posted as of Apr 26, 2021