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

NCT04858308 | Unknown Phase 3 DMC

• 1 other identifier: YYPCT_YYC506_301
• Study Type: interventional
• Target: 554
• Locations: 1 country
• Sites: 3

Brief Summary

Phase 3 study to evaluate the effiacay and safety of YYC506

Conditions

Dyslipidemias

Outcome Measures

Primary Outcomes (1)

• Percent change (%) of non-HDL-C from baseline

  non HDL-C = TC - HDL-C

  from baseline at 12 weeks

Secondary Outcomes (3)

• Percent change (%) of non-HDL-C

  from baseline at 4, 8, 14 weeks.

• Percent change (%) of lipid parameters

  from baseline at 4, 8, 12, 24 weeks

• Percent change (%) of diabetes parameters

  from baseline at 4, 8, 12, 24 weeks

Study Arms (2)

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

YYC506 DRUG

YYC506

Test Group

Control DRUG

Active control

Control Group

YYC506 Placebo DRUG

Placebo

Control Group

Control Placebo DRUG

Placebo

Test Group

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• History of Fibromyalgia, Myopathy etc (CK ≥ 2XULN)
• Uncontrolled hypo-thyroidism (TSH≥1.5XULN)
• Severe renal impairemnet (Creainine clearance \< 30mL/min) etc.

Sponsors & Collaborators

• Yooyoung Pharmaceutical Co., Ltd.: lead

Study Sites (3)

Chonbuk National University Hospital

Cheonju, South Korea

RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, South Korea

NOT YET RECRUITING

Seoul National UniversityHospital

Seoul, South Korea

NOT YET RECRUITING

MeSH Terms

Conditions

Dyslipidemias

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• 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

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seul Gi Ha, PM

CONTACT

82-2-6202-7105; sgha@yypharm.co.kr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Double-blind.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A multicenter, Double-blind, Randomized, Active-controlled, Double dummy, Parelle-group comparative.

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: April 26, 2021
• Study Start: January 29, 2021
• Primary Completion: May 31, 2021
• Study Completion: January 31, 2022
• Last Updated: April 26, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)