Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study

JRCT ID: jRCT2031200367

Registered date:19/02/2021

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Cardiovascular Disease
• Date of first enrollment: 28/07/2020
• Target sample size: 240
• Countries of recruitment: Australia,Japan,Canada,Japan,Iceland,Japan,United States,Japan,Denmark,Japan,Netherlands,Japan
• Study type: Interventional

Intervention(s)

- Drug: olpasiran
Dose 1 Dose 2 Dose 3 Dose 4
- Drug: Placebo
Dose 5

Outcome(s)

Primary Outcome

1. Percentage Change From Baseline in Lipoprotein(a) (Lp[a]) at Week 36 [ Time Frame: Baseline and Week 36 ]
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.

Secondary Outcome

1. Percentage Change From Baseline in Lp(a) at Week 48 [ Time Frame: Baseline and Week 48 ]
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
2. Percentage Change From Baseline in Low Density Lipoprotein Cholesterol (LDL-C) at Week 36 and Week 48 [ Time Frame: Baseline; Week 36 and Week 48 ]
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
3. Percentage Change From Baseline in Apolipoprotein (B) (ApoB) at Week 36 and Week 48 [ Time Frame: Baseline; Week 36 and Week 48 ]
Least squares mean is from the repeated measures linear effects model which includes treatment group, stratification factors, scheduled visit and the interaction of treatment group with scheduled visit.
4. Mean Serum Olpasiran Concentrations at Day 1, Week 24 and Week 48 [ Time Frame: Pre-dose and 1, 3, 6-12, and 24-72 hours post-dose on Day 1 and Week 24; Week 48 ]
Pharmacokinetic blood draws were collected at one timepoint during the 6-12 and 24-72 hour flexible time windows and at Week 48.
Lower limit of quantification (LLOQ) = 0.400 ng/mL. Values below the LLOQ were set to zero.

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

- Age 18 to 80 years
- Lipoprotein (a) > 150 nmol/L
- Evidence of atherosclerotic cardiovascular disease

Exclude criteria

- Severe renal dysfunction
- History or clinical evidence of hepatic dysfunction
- Malignancy within the last 5 years
- Currently receiving, or less than 3 months at Day 1 since receiving > 200 mg/day Niacin

Related Information

• Primary Sponsor: Local Contact
• Secondary ID(s): NCT04270760