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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04270760




Registration number
NCT04270760
Ethics application status
Date submitted
13/02/2020
Date registered
17/02/2020
Date last updated
21/02/2021

Titles & IDs
Public title
Olpasiran Trials of Cardiovascular Events And LipoproteiN(a) Reduction - DOSE Finding Study
Scientific title
A Double-blind, Randomized, Placebo-controlled Phase 2 Study to Evaluate Efficacy, Safety, and Tolerability of Olpasiran (AMG 890) in Subjects With Elevated Lipoprotein(a)
Secondary ID [1] 0 0
2019-003688-23
Secondary ID [2] 0 0
20180109
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Disease 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Olpasiran
Treatment: Drugs - Placebo

Active Comparator: Arm 1 Olpasiran Dose 1 -

Active Comparator: Arm 2 Olpasiran Dose 2 -

Active Comparator: Arm 3 Olpasiran Dose 3 -

Active Comparator: Arm 4 Olpasiran Dose 4 -

Placebo Comparator: Arm 5 Placebo Dose 5 -


Treatment: Drugs: Olpasiran
Dose 1 Dose 2 Dose 3 Dose 4

Treatment: Drugs: Placebo
Dose 5

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percent change in Lp(a)
Timepoint [1] 0 0
Baseline and week 36
Secondary outcome [1] 0 0
Percentage change from baseline in Lp(a)
Timepoint [1] 0 0
Baseline and week 48
Secondary outcome [2] 0 0
Percentage change from baseline in low-density lipoprotein cholesterol (LDL-C)
Timepoint [2] 0 0
Baseline and Weeks 36 and 48
Secondary outcome [3] 0 0
Percentage change in Apolipoprotein(B) (ApoB)
Timepoint [3] 0 0
Baseline and weeks 36 and 48
Secondary outcome [4] 0 0
Maximum observed concentration (Cmax) of Olpasiran
Timepoint [4] 0 0
48 weeks
Secondary outcome [5] 0 0
Area under the concentration-time curve (AUC) of Olpasiran
Timepoint [5] 0 0
48 weeks

Eligibility
Key inclusion criteria
- Age 18 to 80 years

- Lipoprotein (a) > 150 nmol/L

- Evidence of atherosclerotic cardiovascular disease
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Research Site - Camperdown
Recruitment hospital [2] 0 0
Research Site - Milton
Recruitment hospital [3] 0 0
Research Site - Clayton
Recruitment hospital [4] 0 0
Research Site - Nedlands
Recruitment hospital [5] 0 0
Research Site - Woolloongabba
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
4064 - Milton
Recruitment postcode(s) [3] 0 0
3168 - Clayton
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment postcode(s) [5] 0 0
4102 - Woolloongabba
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
Kansas
Country [5] 0 0
United States of America
State/province [5] 0 0
Maryland
Country [6] 0 0
United States of America
State/province [6] 0 0
New York
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Ohio
Country [9] 0 0
United States of America
State/province [9] 0 0
Texas
Country [10] 0 0
Canada
State/province [10] 0 0
Ontario
Country [11] 0 0
Canada
State/province [11] 0 0
Quebec
Country [12] 0 0
Denmark
State/province [12] 0 0
Aarhus N
Country [13] 0 0
Denmark
State/province [13] 0 0
Herlev
Country [14] 0 0
Denmark
State/province [14] 0 0
Viborg
Country [15] 0 0
Iceland
State/province [15] 0 0
Kopavogur
Country [16] 0 0
Japan
State/province [16] 0 0
Chiba
Country [17] 0 0
Japan
State/province [17] 0 0
Hokkaido
Country [18] 0 0
Japan
State/province [18] 0 0
Ishikawa
Country [19] 0 0
Japan
State/province [19] 0 0
Saitama
Country [20] 0 0
Netherlands
State/province [20] 0 0
Amsterdam
Country [21] 0 0
Netherlands
State/province [21] 0 0
Arnhem
Country [22] 0 0
Netherlands
State/province [22] 0 0
The Hague
Country [23] 0 0
Netherlands
State/province [23] 0 0
Utrecht
Country [24] 0 0
Netherlands
State/province [24] 0 0
Venlo

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Amgen
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on
percent change from baseline in lipoprotein(a) (Lp[a]).
Trial website
https://clinicaltrials.gov/show/NCT04270760
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
MD
Address 0 0
Amgen
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Amgen Call Center
Address 0 0
Country 0 0
Phone 0 0
866-572-6436
Fax 0 0
Email 0 0
medinfo@amgen.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04270760