A Study to Evaluate the Efficacy and Safety of Co-administration of AD-2281 and AD-2282

February 2, 2025 updated by: Addpharma Inc.

A Randomized, Double-blind, Active-controlled, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Combined Administration of AD-2281 and AD-2282 in Patients with Primary Hypercholesterolemia.

The purpose of this study is to evaluate the efficacy and safetyof co-administration of AD-2281 and AD-2282 in patients with Primary Hypercholesterolemia

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Signed informed consent
  • Patients with Primary Hypercholesterolemia
  • Other inclusions applied

Exclusion Criteria:

  • Patients with Secondary Hypercholesterolemia
  • Other exclusions applied

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: AD-2281 + AD-2282
Drug: AD-2281
PO, Once daily, 8weeks
Drug: AD-2282
PO, Once daily, 8weeks
Active Comparator: AD-2281 + Placebo of AD-2282
Drug: AD-2281
PO, Once daily, 8weeks
Drug: Placebo of AD-2282
PO, Once daily, 8weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change rate of LDL-C
Time Frame: from baseline at 8 weeks
Percent change (%) of LDL-C from baseline at week 8
from baseline at 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Addpharma Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 1, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

December 19, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 2, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AD-228P3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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