Clinical trial NCT06173570: A Study to Assess the Efficacy, Safety and Tolerability of Different Doses of AZD0780 in Patients With Dyslipidemia
Official title: A Phase IIb, Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Tolerability of AZD0780 in Participants With Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dyslipidemia
Keywords: Dyslipidemia,
Low-Density Lipoprotein Cholesterol
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2023-12-15
Enrollment: 428
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized with equal distribution across 5 parallel treatment arms to either placebo or one of four AZD0780 doses.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Males, and females of non-childbearing potential 18 to 75 years of age, inclusive, at the time of signing the informed consent.
* Participants with a fasting low-density lipoprotein cholesterol (LDL-C) higher than or equal to 70 mg/dL (1.8 mmol/L) and lower than 190 mg/dL (4.9 mmol/L) at screening.
* Participants with fasting triglycerides lower than 400 mg/dL (lower than 4.52 mmol/L) at screening.
* Should be receiving moderate or high-intensity statin therapy for more than or equal to 2 months prior to screening.
* There should be no planned medication or dose change during study participation.
* Body mass index at or above 19.0 kg/m\^2.

Exclusion Criteria:

* History or presence of gastrointestinal, hepatic or renal disease or any other conditions known to interfere with absorption, distribution, metabolism, or excretion of drugs.
* Any uncontrolled or serious disease, or any medical (e.g., known major active infection or major hematological, renal, metabolic, gastrointestinal, respiratory, or endocrine dysfunction) or surgical condition that, in the opinion of the investigator, may either interfere with participation in the clinical study and/or put the participant at significant risk.
* Poorly controlled type 2 diabetes mellitus, defined as hemoglobin A1c (HbA1c) greater than 10 percent at screening.
* Acute ischemic cardiovascular event in the last 12 months.
* Heart failure with New York Heart Association (NYHA) Class III-IV.
* Malignancy (except non-melanoma skin cancers, cervical in-situ carcinoma, breast ductal carcinoma in-situ, or Stage 1 prostate carcinoma) within the last 10 years.
* Recipient of any major organ transplant, e.g., lung, liver, heart, bone marrow, renal.
* LDL or plasma apheresis within 12 months prior to randomization.
* Uncontrolled hypertension.
* Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12 lead ECG as judged by the investigator.

Primary outcomes:
measure: Percent Change in Low-Density Lipoprotein Cholesterol (LDL-C) Level from Baseline to Week 12
timeFrame: From first day of treatment up to week 12
Secondary outcomes:
measure: Percent Change from Baseline of Low-Density Lipoprotein Cholesterol (LDL-C) at Week 12
timeFrame: From first day of treatment up to week 12
measure: AZD0780 Plasma Concentrations Summarized by Sampling Timepoint
timeFrame: From week 1 up to week 12
measure: Percent Change from Baseline at Week 12 in Other Lipid Parameters and Inflammatory Markers
timeFrame: From first day of treatment up to week 12
measure: Percent Change from Baseline at Week 12 in Other Lipid Parameters and Inflammatory Markers
timeFrame: From first day of treatment up to week 12
Other outcomes:
measure: Number of Participants with Adverse Events
timeFrame: From first day of treatment up to week 14
Locations:
city: Huntsville
country: United States
facility: Research Site
state: Alabama
city: Lincoln
country: United States
facility: Research Site
state: California
city: Palm Springs
country: United States
facility: Research Site
state: California
city: Santa Ana
country: United States
facility: Research Site
state: California
city: Boca Raton
country: United States
facility: Research Site
state: Florida
city: Hialeah
country: United States
facility: Research Site
state: Florida
city: Inverness
country: United States
facility: Research Site
state: Florida
city: Jacksonville
country: United States
facility: Research Site
state: Florida
city: Indianapolis
country: United States
facility: Research Site
state: Indiana
city: Louisville
country: United States
facility: Research Site
state: Kentucky
city: New Windsor
country: United States
facility: Research Site
state: New York
city: Greensboro
country: United States
facility: Research Site
state: North Carolina
city: Fargo
country: United States
facility: Research Site
state: North Dakota
city: San Marcos
country: United States
facility: Research Site
state: Texas
city: Barrie
country: Canada
facility: Research Site
state: Ontario
city: Brampton
country: Canada
facility: Research Site
state: Ontario
city: Cambridge
country: Canada
facility: Research Site
state: Ontario
city: Concord
country: Canada
facility: Research Site
state: Ontario
city: Guelph
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Benesov
country: Czechia
facility: Research Site
city: Brandys nad Labem
country: Czechia
facility: Research Site
city: Brno
country: Czechia
facility: Research Site
city: Louny
country: Czechia
facility: Research Site
city: Nachod
country: Czechia
facility: Research Site
city: Praha
country: Czechia
facility: Research Site
city: Pribram
country: Czechia
facility: Research Site
city: Teplice
country: Czechia
facility: Research Site
city: Uherske Hradiste
country: Czechia
facility: Research Site
city: Aarhus
country: Denmark
facility: Research Site
city: Herning
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: Svendborg
country: Denmark
facility: Research Site
city: Viborg
country: Denmark
facility: Research Site
city: Budapest
country: Hungary
facility: Research Site
city: Debrecen
country: Hungary
facility: Research Site
city: Orosháza
country: Hungary
facility: Research Site
city: Pécs
country: Hungary
facility: Research Site
city: Chuo-ku
country: Japan
facility: Research Site
city: Itabashi-ku
country: Japan
facility: Research Site
city: Bratislava
country: Slovakia
facility: Research Site
city: Brezno
country: Slovakia
facility: Research Site
city: Lucenec
country: Slovakia
facility: Research Site
city: Presov
country: Slovakia
facility: Research Site
city: Roznava
country: Slovakia
facility: Research Site
city: Svidnik
country: Slovakia
facility: Research Site
city: Trebisov
country: Slovakia
facility: Research Site
city: A Coruña
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Cordoba
country: Spain
facility: Research Site
city: Ferrol
country: Spain
facility: Research Site
city: Santiago(A Coruña)
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
city: Sevilla
country: Spain
facility: Research Site
Study officials:
References: