Study identifier:D7960C00017
ClinicalTrials.gov identifier:NCT06742853
EudraCT identifier:N/A
CTIS identifier:N/A
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.
Dyslipidemia
Phase 1
Yes
AZD0780, Ezetimibe, Rosuvastatin, Bempedoic Acid, Placebo
All
48
Interventional
18 Years - 75 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: -
Primary Purpose: Treatment
Verified 01 Dec 2024 by AstraZeneca
AstraZeneca
-
No locations available
Arms | Assigned Interventions |
---|---|
Experimental: Ezetimibe + AZD0780 Participants will receive ezetimibe 10 mg and AZD0780 once daily (QD) for 4 weeks. | Drug: AZD0780 AZD0780 tablet will be administered orally. Drug: Ezetimibe Ezetimibe tablet will be administered orally. |
Experimental: Rosuvastatin + Ezetimibe + AZD0780 Participants will receive rosuvastatin 20 mg, ezetimibe 10 mg and AZD0780 QD for 4 weeks. | Drug: AZD0780 AZD0780 tablet will be administered orally. Drug: Ezetimibe Ezetimibe tablet will be administered orally. Drug: Rosuvastatin Rosuvastatin tablet will be administered orally. |
Experimental: Bempedoic Acid + Ezetimibe + AZD0780 (Optional Cohort) Participants will receive bempedoic acid 180 mg, ezetimibe 10 mg and AZD0780 QD for 4 weeks. | Drug: AZD0780 AZD0780 tablet will be administered orally. Drug: Ezetimibe Ezetimibe tablet will be administered orally. Drug: Bempedoic Acid Bempedoic Acid tablet will be administered orally. |
Placebo Comparator: Ezetimibe + Placebo Participants will receive ezetimibe 10 mg and placebo QD for 4 weeks. | Drug: Ezetimibe Ezetimibe tablet will be administered orally. Drug: Placebo Placebo will be administered orally. |
Placebo Comparator: Rosuvastatin + Ezetimibe + Placebo Participants will receive rosuvastatin 20 mg, ezetimibe 10 mg and placebo QD for 4 weeks. | Drug: Ezetimibe Ezetimibe tablet will be administered orally. Drug: Rosuvastatin Rosuvastatin tablet will be administered orally. Drug: Placebo Placebo will be administered orally. |
Placebo Comparator: Bempedoic Acid + Ezetimibe + Placebo (Optional Cohort) Participants will receive bempedoic acid 180 mg, ezetimibe 10 mg and placebo QD for 4 weeks. | Drug: Ezetimibe Ezetimibe tablet will be administered orally. Drug: Bempedoic Acid Bempedoic Acid tablet will be administered orally. Drug: Placebo Placebo will be administered orally. |