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NCT06005597 · ClinicalTrials.gov registry record · Phase 3
Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies
A Phase 3 study, sponsored by NewAmsterdam Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 407
- Enrollment target
NCT06005597: Completed Phase 3 study, sponsored by NewAmsterdam Pharma.
NCT06005597 is a Phase 3 study that has completed, run by NewAmsterdam Pharma. The registered enrollment target is 407 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06005597, a Phase 3 study, has completed, sponsored by NewAmsterdam Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 407 participants
- Enrollment target
Study Summary
The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg and ezetimibe 10mg fixed dose combination as an adjunct to diet and maximally tolerated lipid-lowering therapy.
Primary Outcome
LS mean percent change in low-density lipoprotein cholesterol (LDL-C) from baseline to Day 84 in the obicetrapib 10 mg/ezetimibe 10 mg fixed-dose combination (FDC) group compared to the placebo group. LDL-C level was measured by preparative ultracentrifugation (PUC).
Interventions
- COMBINATION_PRODUCT Combination Therapy
- DRUG Monotherapy obicetrapib
- DRUG Monotherapy ezetimibe
- OTHER Combination Therapy placebo
- OTHER Obicetrapib Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 407 participants |
| Start Date | 2024-03-01 |
| Est. Completion | 2024-10-16 |
| Phase | Phase 3 |
What the finished NCT06005597 record still lists
NCT06005597 is an interventional study that assigns participants to a tested intervention. The registered 407 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (47% lower).
The record links to 0 conditions, and to 5 interventions - of which Combination Therapy is the first listed.
NCT06005597 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06005597 about?
NCT06005597 is a clinical study titled "Study of Obicetrapib & Ezetimibe Fixed Dose Combination on Top of Maximum Tolerated Lipid-Modifying Therapies". The study is a placebo-controlled, double-blind, randomized, phase 3 study in participants with heterozygous familial hypercholesterolemia (HeFH) and/or atherosclerotic cardiovascular disease (ASCVD) or multiple ASCVD risk factors to evaluate the efficacy, safety and tolerability of obicetrapib 10mg...
What is the current status of trial NCT06005597?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 407 participants. The study started on 2024-03-01. Estimated completion is 2024-10-16.
What interventions are being tested in trial NCT06005597?
The interventions under investigation include: Combination Therapy (COMBINATION_PRODUCT), Monotherapy obicetrapib (DRUG), Monotherapy ezetimibe (DRUG), Combination Therapy placebo (OTHER), Obicetrapib Placebo (OTHER).
Who is sponsoring clinical trial NCT06005597?
This trial is sponsored by NewAmsterdam Pharma, which has 15 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06005597's enrollment target sits among peer trials
407 913th of 2000 higher than 1,088 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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