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

Sponsor

Amgen (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT04270760

Collaborator

(none)

290

Enrollment

Locations

Arms

27.2

Anticipated Duration (Months)

8.1

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Evaluate the effect of olpasiran administered subcutaneously (SC) compared with placebo, on percent change from baseline in lipoprotein(a) (Lp[a]).

Condition or Disease	Intervention/Treatment	Phase
Cardiovascular Disease	Drug: Olpasiran Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

290 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official 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)

Actual Study Start Date :

Jul 28, 2020

Actual Primary Completion Date :

Dec 27, 2021

Anticipated Study Completion Date :

Nov 2, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Arm 1 Olpasiran Dose 1	Drug: Olpasiran Dose 1 Dose 2 Dose 3 Dose 4 Other Names: AMG 890
Active Comparator: Arm 2 Olpasiran Dose 2	Drug: Olpasiran Dose 1 Dose 2 Dose 3 Dose 4 Other Names: AMG 890
Active Comparator: Arm 3 Olpasiran Dose 3	Drug: Olpasiran Dose 1 Dose 2 Dose 3 Dose 4 Other Names: AMG 890
Active Comparator: Arm 4 Olpasiran Dose 4	Drug: Olpasiran Dose 1 Dose 2 Dose 3 Dose 4 Other Names: AMG 890
Placebo Comparator: Arm 5 Placebo Dose 5	Drug: Placebo Dose 5

Outcome Measures

Primary Outcome Measures

Percent change in Lp(a) [Baseline and week 36]

Secondary Outcome Measures

Percentage change from baseline in Lp(a) [Baseline and week 48]
Percentage change from baseline in low-density lipoprotein cholesterol (LDL-C) [Baseline and Weeks 36 and 48]
Percentage change in Apolipoprotein(B) (ApoB) [Baseline and weeks 36 and 48]
Maximum observed concentration (Cmax) of Olpasiran [48 weeks]
Area under the concentration-time curve (AUC) of Olpasiran [48 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westside Medical Associates of Los Angeles	Beverly Hills	California	United States	90211
2	Excel Medical Clinical Trials	Boca Raton	Florida	United States	33434
3	Piedmont Healthcare	Atlanta	Georgia	United States	30309
4	University of Kansas Medical Center	Kansas City	Kansas	United States	66160
5	Johns Hopkins	Baltimore	Maryland	United States	21287
6	New York University	New York	New York	United States	10016
7	Mount Sinai Hospital	New York	New York	United States	10029
8	Columbia University Medical Center	New York	New York	United States	10032
9	Crossroads Clinical Research Inc	Mooresville	North Carolina	United States	28117
10	Cleveland Clinic	Cleveland	Ohio	United States	44195
11	Baylor College of Medicine	Houston	Texas	United States	77030
12	Protenium Clinical Research	Hurst	Texas	United States	76054
13	Royal Prince Alfred Hospital	Camperdown	New South Wales	Australia	2050
14	Core Research Group Pty Ltd	Milton	Queensland	Australia	4064
15	Monash Medical Centre	Clayton	Victoria	Australia	3168
16	Linear Clinical Research Limited	Nedlands	Western Australia	Australia	6009
17	Dr Heart Pty Ltd	Woolloongabba		Australia	4102
18	LMC Clinical Research Incorporated	Brampton	Ontario	Canada	L6S 0C6
19	LMC Clinical Research Incorporated Thornhill	Concord	Ontario	Canada	L4K 4M2
20	Ecogene-21	Chicoutimi	Quebec	Canada	G7H 7K9
21	Research Institute of McGill University Health Center - Glen Site	Montreal	Quebec	Canada	H4A 3J1
22	Clinique des Maladies Lipidiques de Quebec Incorporated	Quebec		Canada	G1V 4W2
23	Aarhus Universitetshospital	Aarhus N		Denmark	8200
24	Herlev Gentofte Hospital	Herlev		Denmark	2730
25	Regionshospitalet Viborg	Viborg		Denmark	8800
26	Thjonustumidstod Rannsoknaverkefna	Kopavogur		Iceland	201
27	Asahi General Hospital	Asahi-shi	Chiba	Japan	289-2511
28	The Jikei University Kashiwa Hospital	Kashiwa-shi	Chiba	Japan	277-8567
29	Asahikawa City Hospital	Asahikawa-shi	Hokkaido	Japan	070-8610
30	Kanazawa Medical University Hospital	Kahoku-gun	Ishikawa	Japan	920-0293
31	Saitama Medical University Hospital	Iruma-gun	Saitama	Japan	350-0495
32	Academisch Medisch Centrum	Amsterdam		Netherlands	1105 AZ
33	Rijnstate Ziekenhuis	Arnhem		Netherlands	6815 AD
34	Haga Ziekenhuis	The Hague		Netherlands	2545 AA
35	Universitair Medisch Centrum Utrecht	Utrecht		Netherlands	3584 CX
36	VieCuri Medisch Centrum	Venlo		Netherlands	5912 BL