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

Phase 3RecruitingNCT05400317

Addpharma Inc.520 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

520

Conditions

Mixed Dyslipidemia

Interventions

AD-218DRUG

PO, Once daily(QD), 12weeks

AD-218ADRUG

PO, Once daily(QD), 12weeks

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (1)

Yeongnam University Hospital

Daegu, Nam-gu, South Korea

RECRUITING

Outcomes

Primary Outcomes

Percent change (%) of non-HDL-C from baseline at week 12

non-HDL-C at week 12 compared AD-218 with AD-218A

Time frame: from baseline at 12 weeks

Secondary Outcomes

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

Time frame: from baseline at week 4,8

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

Lipid panel at week 4, 8, 12 compared AD-218 with AD-218A

Time frame: from baseline at week 4, 8, 12

Central Contacts

Sarah Yoon

CONTACT

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

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

CONTACT

Data from ClinicalTrials.gov

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