Trials / Completed
CompletedNCT06742853
A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C.
A Phase 1, Randomized, Single-blind, Placebo-controlled Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 in Combination With Ezetimibe, Ezetimibe/Rosuvastatin, or Ezetimibe/Bempedoic Acid in Healthy Male and Female Participants 18 to 75 Years of Age With Elevated LDL-C.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 81 (actual)
- Sponsor
- AstraZeneca · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Accepted
Summary
The main aim of this study is to assess the effects of AZD0780 when added on top of ezetimibe or ezetimibe and rosuvastatin or ezetimibe and bempedoic acid.
Detailed description
This is a randomized, single-blind, placebo-controlled study in healthy participants with elevated low-density lipoprotein-cholesterol (LDL-C). This study will assess the pharmacokinetic (PK), safety, tolerability, and efficacy of AZD0780 in combination with ezetimibe, ezetimibe/rosuvastatin, and ezetimibe/bempedoic acid. Participants will be randomized to receive either AZD0780 or placebo (to be administered with ezetimibe, ezetimibe/rosuvastatin, or ezetimibe/bempedoic acid). The study will comprise: 1. A Screening Period of up to 28 days. 2. A Run-in Period of 28 days. 3. A Treatment Period of 28 days. 4. Two Follow-up Visits, one and two weeks after the last dose of study drug.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | AZD0780 | AZD0780 tablet will be administered orally. |
| DRUG | Ezetimibe | Ezetimibe tablet will be administered orally. |
| DRUG | Rosuvastatin | Rosuvastatin tablet will be administered orally. |
| DRUG | Bempedoic Acid | Bempedoic Acid tablet will be administered orally. |
| DRUG | Placebo | Placebo will be administered orally. |
Timeline
- Start date
- 2024-12-20
- Primary completion
- 2025-10-29
- Completion
- 2025-10-29
- First posted
- 2024-12-19
- Last updated
- 2025-11-10
Locations
3 sites across 2 countries: United States, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06742853. Inclusion in this directory is not an endorsement.