Evaluation of Obicetrapib on Antioxidant Levels in Plasma and HDL Particles of Healthy Volunteers

Phase 2RecruitingNCT06982508

NewAmsterdam Pharma100 enrolled

Overview

The goal of this clinical trial is to learn if Obicetrapib works to change antioxidant levels in HDL and plasma, as well as retinal tissue. The main questions it aims to answer are: Do Obicetrapib effect absorption of antioxidants in a person's blood or their eye tissue? Researchers will compare Obicetrapib to a placebo (a look-alike substance that contains no drug) to see if Obicetrapib helps improve a person's ability to absorb antioxidants. Participants will: Take Obicetrapib or a placebo every day for 4 months Visit the clinic once every 8 weeks for checkups and tests Have their blood taken and their eyes checked to measure antioxidant levels

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

100

Conditions

Antioxidant Absorption

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Visual acuity \> 20/60 in both eyes with or without corrective lenses Exclusion Criteria: * Type 2 diabetes * Active liver disease * Any clinically significant macular pathology

Outcomes

Primary Outcomes

Sum of Percent Change of Antioxidant Levels within HDL

The primary efficacy endpoint is the effect of obicetrapib on the sum of the percent changes in lutein, zeaxanthin, and α-tocopherol levels within HDL particles from baseline to visit 4 (week 16) compared to placebo.

Time frame: 16 Weeks

Secondary Outcomes

Effects of Obicetrapib on Percent Changes of Antioxidant Levels in Retinal Tissue, Plasma, and HDL Particles

The secondary efficacy endpoints are the effect of obicetrapib compared to placebo on the percent changes from baseline to visit 3 (week 8) and baseline to visit 4 (week 16) for the following variables: * MPOD * Plasma level of α-tocopherol * Plasma level of lutein * Plasma level of zeaxanthin * Lutein within HDL particles * Zeaxanthin within HDL particles * α-tocopherol within HDL particles * Sum of the percent changes in lutein, zeaxanthin, and α-tocopherol in plasma * Sum of the percent changes in lutein, zeaxanthin, and α-tocopherol within HDL particles from baseline to visit 3 (week 8) * LDL-C * HDL-C * Non-HDL-C * ApoA1 * ApoB * Lp(a) * TC * TG

Time frame: 8 and 16 weeks