A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD0780 in Participants With Dy… (NCT06834932) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of AZD0780 in Participants With Dyslipidaemia
China432 participantsStarted 2024-12-06
Plain-language summary
This is a randomised, double-blind, placebo-controlled, multi-centre, sequential Phase II and Phase III study that will evaluate the efficacy, safety, and PK of AZD0780 administered orally for up to 52 weeks in participants with elevated LDL-C. The study consist of 2 separate parts (Part A and Part B) approximately 60 participants will be randomised in Part A. There will be 2 cohorts in Part B (approximately 220 participants in Cohort 1 and 100 participants in Cohort 2).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Males, and females of non-childbearing potential, 18 to 55 years of age, at the time of signing the informed consent.
✓. Diagnosis of dyslipidaemia: and with fasting LDL-C ≥ 100 mg/dL (2.6 mmol/L) and \< 190 mg/dL (4.9 mmol/L) at screening (Visit 1).
✓. Not on any LLTs for ≥ 8 weeks prior to screening (Visit 1), except for a heart-healthy lifestyle.
✓. No planned LLTs using during study participation.
✓. Body mass index ≥ 18 and ≤35 kg/m\^2 , weigh ≥50 kg and ≤120 kg.
✓. Males, and females, ≥ 18 years of age, at the time of signing the informed consent.
✓. Meets one of the ASCVD status/risk categories and has a corresponding fasted LDL-C value at screening (Visit 1) .
Exclusion criteria
✕. 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, eg, lung, liver, heart, bone marrow, renal.
✕. Homozygous familial hypercholesterolaemia, Know diagnosis of HeFH, LDL apheresis or plasma apheresis within 12 months prior to screening (Visit 1).
✕
What they're measuring
1
AZD0780 Concentrations in plasma (PART A)
Timeframe: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)
2
AZD0780 PK Parameter: AUC0-t (PART A, intensive PK subgroup).
Timeframe: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)
3
AZD0780 PK parameter: Cmax (PART A, intensive PK subgroup)
Timeframe: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)
4
AZD0780 PK parameter: AUCtau (PART A, intensive PK sub group)
Timeframe: Day 1 and Day 8: Pre-dose, 0.25,0.5,1,1.5,2,3,4,6,8,12,16 hours post-dose. Day 2, Day 9, Day 11, Day 15, Day 22, Day 29: Pre-dose (PART A)
5
Relative change in LDL-C from baseline to 12 weeks (PART B)
. QTcF \> 450 ms; high degree atrioventricular-block grade II-III and sinus node dysfunction with significant sinus pause untreated with pacemaker; and cardiac tachyarrhythmias.
✕. A LDL-C reduction that is \< 30% post rosuvastatin run-in period (Day -8).
✕. Acute ischaemic ASCVD event within 7 days prior to screening (Visit 1).
✕. Any uncontrolled or serious disease.
✕. eGFR \< 15 mL/min/1.73m2 using the CKD-EPI 2021 (age, sex) equation at screening (Visit 1).