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

Phase 3

Recruiting

• Conditions: Mixed Dyslipidemia
• Interventions: Drug: AD-218; Drug: AD-218A

• Registration Number: NCT05400317
• Lead Sponsor: Addpharma Inc.

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

Study Timeline

• Study First Submitted: 2022-05-27
• Study First Submitted QC: 2022-05-27
• Study First Posted: 2022-06-01
• Study Start: 2022-07-27
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-29
• Last Update Posted: 2024-01-31
• Primary Completion: 2025-03-31
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active Comparator : Test group	AD-218	AD-218
Active Comparator : Control group	AD-218A	AD-218A

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Yeongnam University Hospital; 🇰🇷 Daegu, Nam-gu, Korea, Republic of