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

NCT06982508 — Phase 2, Recruiting, 100 participants, NewAmsterdam Pharma

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A Randomized, Double-Blind, Placebo-Controlled Parallel Trial to Assess the Effects of Obicetrapib on Levels of Antioxidants in Plasma and HDL Particles in Healthy Volunteers: The VERMEER Study

Registry	NCT06982508, acronym VERMEER
Status	Recruiting
Phase	Phase 2
Study type	Interventional; randomized, parallel, masking: double, basic science
Enrollment	100 (Estimated)
Sponsor	NewAmsterdam Pharma (Industry); collaborators: Midwest Biomedical Research
Conditions	Antioxidant Absorption
Interventions	Obicetrapib 10mg, Placebo (Drug)
Dates	start 2025-09-09, primary completion 2026-09-01 (estimated), completion 2026-12-01 (estimated), first posted 2025-05-21, last updated 2025-10-20
Locations	1 site in United States

-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

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+Arms and interventions

Arm	Type	Interventions	Description
Obicetrapib 10mg	Experimental	Drug: Obicetrapib 10mg
Placebo	Placebo comparator	Drug: Placebo

Obicetrapib 10mg (Drug): Active Drug
Placebo (Drug): Placebo Control

+Outcome measures

Primary outcomes

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 outcomes

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) * LDL-C * HDL-C * Non-HDL-C * ApoA1 * ApoB * Lp(a) * TC * TG

+Eligibility

Sex: All, ages: 18 Years to 75 Years, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Excellence Medical Research	Miami Gardens, Florida	United States	Recruiting