A Phase 2 interventional study of Obicetrapib 10mg and Placebo in Antioxidant Absorption, sponsored by NewAmsterdam Pharma. Recruiting at 1 site in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-20.
Sponsored by NewAmsterdam Pharma · Phase 2, Interventional, and Basic science
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
NewAmsterdam Pharma is the lead sponsor of 20 studies on the registry; 3 are open to participants now.
Of its 13 completed or terminated interventional studies of FDA-regulated products, 8 (62%) have results posted.
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Exclusion Criteria:
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Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Obicetrapib 10mg
Drug: Placebo
Active Drug
Placebo Control
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
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
Started Sep 2025 (actual). Primary completion is estimated for Sep 2026, 12 months after the start.
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Studies of the drug tested here: TA-8995
NewAmsterdam Pharma