A Study to Investigate the Pharmacokinetics, Safety, Tolerability, and Efficacy of AZD0780 With Ezetimibe Combinations in Healthy Adults With Elevated LDL-C.

Part of paid clinical trials in Glendale, California.

Sponsor
AstraZeneca
Study ID
NCT06742853
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • AZD0780 — DRUG
    AZD0780 tablet will be administered orally.
  • Ezetimibe — DRUG
    Ezetimibe tablet will be administered orally.
  • Rosuvastatin — DRUG
    Rosuvastatin tablet will be administered orally.
  • Bempedoic Acid — DRUG
    Bempedoic Acid tablet will be administered orally.
  • Placebo — DRUG
    Placebo will be administered orally.

Study Details

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.

Key Dates

Start date
Dec 20, 2024
Status verified
Nov 2025
Primary completion
Oct 29, 2025
Completion
Oct 29, 2025

Study Design

Enrollment
81 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ezetimibe + AZD0780
    Participants will receive ezetimibe 10 mg and AZD0780 once daily (QD) for 4 weeks.
  • Experimental: Rosuvastatin + Ezetimibe + AZD0780
    Participants will receive rosuvastatin 20 mg, ezetimibe 10 mg and AZD0780 QD for 4 weeks.
  • Experimental: Bempedoic Acid + Ezetimibe + AZD0780 (Optional Cohort)
    Participants will receive bempedoic acid 180 mg, ezetimibe 10 mg and AZD0780 QD for 4 weeks.
  • Placebo Comparator: Ezetimibe + Placebo
    Participants will receive ezetimibe 10 mg and placebo QD for 4 weeks.
  • Placebo Comparator: Rosuvastatin + Ezetimibe + Placebo
    Participants will receive rosuvastatin 20 mg, ezetimibe 10 mg and placebo QD for 4 weeks.
  • Placebo Comparator: Bempedoic Acid + Ezetimibe + Placebo (Optional Cohort)
    Participants will receive bempedoic acid 180 mg, ezetimibe 10 mg and placebo QD for 4 weeks.

Primary Outcome Measure

Change from baseline in direct Low-density Lipsprotein Cholesterol (LDL-C) [ Time Frame: Week 4 ]

Locations (2)

FacilityCityStateZIPSite coordinators
Research SiteGlendaleCalifornia91206-
Research SiteBrooklynMaryland21225-

Find similar trials in Glendale, CA

By research site
Research Site· Glendale, CAResearch Site· Brooklyn, MD

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