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

JRCT ID: jRCT2031230580

Registered date:22/01/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Dyslipidemia
• Date of first enrollment: 31/01/2024
• Target sample size: 375
• Countries of recruitment: Spain,Japan,Hungary,Japan,Denmark,Japan,Slovakia,Japan,Czech Republic,Japan,Canada,Japan,United States of America,Japan
• Study type: Interventional

Intervention(s)

AZD0780 arm: AZD0780 tablet administerd orally, once daily(QD). Unit dose strengths: 1mg, 3mg, 10mg or 30mg
Placebo arm: Placebo tablet matching AZD0780, administered orally, once daily (QD).

Outcome(s)

Primary Outcome

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 ]

Blood samples will be collected and LDL-C level for baseline up to week 12 assessed to evaluate the effect of different doses of AZD0780 compared to placebo, in 'ideal' scenarios in which intercurrent events would not occur.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 75age old

Include 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 or equal to 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.

Exclude 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 (eg, 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.

Related Information

• Primary Sponsor: Ageishi Yuji
• Secondary ID(s): NCT06173570