A Study to Evaluate the Efficacy and Safety of AD-218 | NCT05400317

Studies
A Study to Evaluate the Efficacy and Safety of AD-218

NCT05400317

Sponsor

Addpharma Inc.

Status

Recruiting

Last Update Posted

Feb 5, 2025Actual

Enrollment

520Estimated

Phase

Phase 3

Conditions

Mixed Dyslipidemia

Interventions

AD-218
AD-218A

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

Feb 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 27, 2022Actual

Primary Completion Date

Mar 31, 2026Estimated

Completion Date

Jun 30, 2026Estimated

First Submitted Date

May 27, 2022

First Submission Date that Met QC Criteria

May 27, 2022

First Posted Date

Jun 1, 2022Actual

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

Feb 3, 2025

Last Update Posted Date

Feb 5, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of AD-218

Detailed Description

Condition or disease : Mixed Dyslipidemia Treatment Drug : AD-218, AD-218A, Placebo of AD-218, Placebo of AD-218A

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

520Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active Comparator : Test group	Experimental	AD-218	Drug: AD-218
Active Comparator : Control group	Active Comparator	AD-218A	Drug: AD-218A

Interventions

Name	Type	Description	Arm Group Labels	Other Names
AD-218	Drug	PO, Once daily(QD), 12weeks	Active Comparator : Test group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percent change (%) of non-HDL-C from baseline at week 12	non-HDL-C at week 12 compared AD-218 with AD-218A	from baseline at 12 weeks

Secondary Outcomes

Measure	Description	Time Frame
Percent change (%) of non-HDL-C from baseline at week 4, 8	non-HDL-C at week 4,8 compared AD-218 with AD-218A	from baseline at week 4,8
Percent change (%) of Lipid panel from baseline at week 4, 8, 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A man or woman over 19 years old.
Sign on ICF prior to study participation

Exclusion Criteria:

History of Fibromyalgia, Myopathy etc (CK ≥ 2 X ULN)
Other exclusions applied

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sarah Yoon	Contact	82-031-891-5576		sryoon@addpharma.co.kr
Kyu Chang Won, M.D., Ph.D	Contact

Overall Officials

Name	Affiliation	Role
Kyu Chang Won, M.D., Ph.D	Yeungnam University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yeongnam University Hospital	Recruiting	Daegu	Nam-gu	42415	South Korea

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