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

Phase 2

Not yet recruiting

• Conditions: Antioxidant Absorption
• Interventions: Drug: Obicetrapib 10mg; Drug: Placebo

• Registration Number: NCT06982508
• Lead Sponsor: NewAmsterdam Pharma

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-13
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-08
• Primary Completion: 2026-04
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obicetrapib 10mg	Obicetrapib 10mg	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Sum of Percent Change of Antioxidant Levels within HDL	16 Weeks	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.

Secondary Outcome Measures

Name	Time	Method
Effects of Obicetrapib on Percent Changes of Antioxidant Levels in Retinal Tissue, Plasma, and HDL Particles	8 and 16 weeks	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)