A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
AstraZeneca
Study ID
NCT06173570
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • AZD0780 — DRUG
    AZD0780 administered orally, once daily for 12 weeks
  • Placebo — DRUG
    Placebo administered orally, once daily for 12 weeks

Study Details

The primary purpose of this study is to measure the effect of different daily doses of AZD0780 on Low-Density Lipoprotein (LDL-C) levels compared with placebo in participants with dyslipidemia. The effect of AZD0780 versus placebo on other lipid parameters and inflammatory markers is also investigated. The concentration of AZD0780 in blood at specific timepoints is measured, and the safety and tolerability of AZD0780 will be evaluated. There is a follow-up after end of treatment, but expanded access is not available. The primary hypothesis is that at least one of the investigated doses of AZD0780 is superior to placebo in lowering LDL-C level, in percent change from baseline up to week 12.

Key Dates

Start date
Jan 19, 2024
Status verified
Nov 2025
Primary completion
Sep 30, 2024
Completion
Sep 30, 2024

Study Design

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

Arms

  • Experimental: Arm A
    AZD0780, Dose 1
  • Experimental: Arm B
    AZD0780, Dose 2
  • Experimental: Arm C
    AZD0780, Dose 3
  • Experimental: Arm D
    AZD0780, Dose 4
  • Placebo Comparator: Arm E
    Placebo, matched for appearance

Primary Outcome Measure

Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Level From Baseline to Week 12 [ Time Frame: From first day of treatment up to week 12 ]

Locations (14)

FacilityCityStateZIPSite coordinators
Research SiteHuntsvilleAlabama35801-
Research SiteLincolnCalifornia95648-
Research SitePalm SpringsCalifornia92262-
Research SiteSanta AnaCalifornia92704-
Research SiteBoca RatonFlorida33434-
Research SiteHialeahFlorida33012-
Research SiteInvernessFlorida34452-
Research SiteJacksonvilleFlorida32216-
Research SiteIndianapolisIndiana46260-
Research SiteLouisvilleKentucky40213-
Research SiteNew WindsorNew York12553-
Research SiteGreensboroNorth Carolina27408-
Research SiteFargoNorth Dakota58104-
Research SiteSan MarcosTexas78666-

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By research site
Research Site· Huntsville, ALResearch Site· Lincoln, CAResearch Site· Palm Springs, CAResearch Site· Santa Ana, CAResearch Site· Boca Raton, FLResearch Site· Hialeah, FL

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