NCT05400317

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
520

participants targeted

Target at P75+ for phase_3

Timeline
2mo left

Started Jul 2022

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jul 2022Jun 2026

First Submitted

Initial submission to the registry

May 27, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 1, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 27, 2022

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Expected
Last Updated

February 5, 2025

Status Verified

February 1, 2025

Enrollment Period

3.7 years

First QC Date

May 27, 2022

Last Update Submit

February 3, 2025

Conditions

Mixed Dyslipidemia

Outcome Measures

Primary Outcomes (1)

  • 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 (2)

  • Percent change (%) of non-HDL-C from baseline at week 4, 8

    from baseline at week 4,8

  • Percent change (%) of Lipid panel from baseline at week 4, 8, 12

    from baseline at week 4, 8, 12

Study Arms (2)

Active Comparator : Test group

EXPERIMENTAL

AD-218

Drug: AD-218

Active Comparator : Control group

ACTIVE COMPARATOR

AD-218A

Drug: AD-218A

Interventions

AD-218DRUG

PO, Once daily(QD), 12weeks

Active Comparator : Test group
AD-218ADRUG

PO, Once daily(QD), 12weeks

Active Comparator : Control group

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • History of Fibromyalgia, Myopathy etc (CK ≥ 2 X ULN)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yeongnam University Hospital

Daegu, Nam-gu, 42415, South Korea

RECRUITING

Study Officials

  • Kyu Chang Won, M.D., Ph.D

    Yeungnam University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Yoon

CONTACT

82-031-891-5576sryoon@addpharma.co.kr

Kyu Chang Won, M.D., Ph.D

CONTACT

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2022

First Posted

June 1, 2022

Study Start

July 27, 2022

Primary Completion

March 31, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 5, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)