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

NCT06982508 | Recruiting Phase 2 FDA Drug

• 1 other identifier: TA-8995-207
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Antioxidant Absorption

Keywords

Healthy Volunteer

Outcome Measures

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.

  16 Weeks

Secondary Outcomes (1)

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

  8 and 16 weeks

Study Arms (2)

Obicetrapib 10mg

EXPERIMENTAL

Drug: Obicetrapib 10mg

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Obicetrapib 10mg DRUG

Active Drug

Obicetrapib 10mg

Placebo DRUG

Placebo Control

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Type 2 diabetes
• Active liver disease
• Any clinically significant macular pathology

Sponsors & Collaborators

• NewAmsterdam Pharma: lead
• MB Clinical Research and Consulting LLC: collaborator

Study Sites (1)

Excellence Medical Research

Miami Gardens, Florida, 33169, United States

RECRUITING

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: September 9, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 20, 2025

Record last verified: 2025-10

Locations

US (1)