Health TrialsbyHealthPanel

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

ConditionAntioxidant Absorption
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorNewAmsterdam Pharma

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Visual acuity > 20/60 in both eyes with or without corrective lenses

Disqualifiers

Type 2 diabetes

Active liver disease

Any clinically significant macular pathology

Trial design

Design model

Parallel

Treatments tested in this trial

  • Obicetrapib 10mg

    Drug

    Active Drug

  • Placebo

    Drug

    Placebo Control

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Obicetrapib 10mgExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

NewAmsterdam Pharma

Lead sponsor

MB Clinical Research and Consulting LLC

Collaborator

Source ClinicalTrials.gov
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