Trials / Completed
CompletedNCT04770389
Randomized Study of Obicetrapib in Combination With Ezetimibe
A Placebo-Controlled, Double-Blind, Randomized Phase 2 Study to Evaluate the Effect of Obicetrapib in Combination With Ezetimibe in Participants With Mild Dyslipidemia
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 112 (actual)
- Sponsor
- NewAmsterdam Pharma · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study will be a placebo-controlled, double-blind, randomized, phase 2 study in participants with mild dyslipidemia to evaluate the efficacy, safety, and tolerability of obicetrapib and ezetimibe combination therapy.
Detailed description
This study will be a placebo-controlled, double-blind, randomized, phase 2 study in participants with mild dyslipidemia to evaluate the efficacy, safety, and tolerability of obicetrapib and ezetimibe combination therapy. The screening period for this study will take up to 2 weeks. Following the screening period, eligible patients will be randomized to placebo, 5 mg obicetrapib + 10 mg ezetimibe; 5 mg obicetrapib + placebo ezetimibe; or placebo obicetrapib + 10 mg ezetimibe for an 8 week treatment period. After the treatment period, patients will continue for a 4 week safety follow-up and a 8 week PK follow-up.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Obicetrapib 5mg | tablet |
| DRUG | Ezetimibe 10mg | tablet |
| OTHER | Placebo | tablet |
Timeline
- Start date
- 2021-02-23
- Primary completion
- 2021-05-07
- Completion
- 2021-06-30
- First posted
- 2021-02-25
- Last updated
- 2024-04-24
- Results posted
- 2024-04-24
Locations
9 sites across 2 countries: United States, Netherlands
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04770389. Inclusion in this directory is not an endorsement.