Single Dose Olpasiran Normal Hepatic Function for Hepatic Impairment

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Hepatic Impairment+1 More
Olpasiran - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is looking at how well a single dose of olpasiran works in people with different levels of liver function, compared to people with normal liver function.

Eligible Conditions
  • Hepatic Impairment

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

3 Primary · 7 Secondary · Reporting Duration: Predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), Day 15, and Day 29

Day 29
Area Under the Plasma Concentration-time Curve from Time Zero to Infinity (AUCinf) of Olpasiran
Area Under the Plasma Concentration-time Curve from Time Zero to the Last Quantifiable Concentration (AUClast) of Olpasiran
Maximum Observed Serum Concentration (Cmax) of Olpasiran
Day 85
Area Under the Effect Time Curve (AUEC) of Plasma Lipoprotein a (Lp[a])
Maximum Inhibitory Effect (Imax) of Plasma Lp(a)
Time to Reach Imax of Lp(a)
Up to Day 85
Number of Participants Who Experience an Adverse Event (AE)
Number of Participants With Clinically Significant Changes 12-lead Electrocardiogram (ECG) Measurements
Number of Participants with Clinically Significant Changes in Clinical Laboratory Evaluations
Number of Participants with Clinically Significant Changes in Vital Signs

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Single Dose Olpasiran Normal Hepatic Function
1 of 2
Single Dose Olpasiran Hepatic Impairment
1 of 2

Experimental Treatment

24 Total Participants · 2 Treatment Groups

Primary Treatment: Single Dose Olpasiran Normal Hepatic Function · No Placebo Group · Phase 1

Single Dose Olpasiran Normal Hepatic Function
Drug
Experimental Group · 1 Intervention: Olpasiran · Intervention Types: Drug
Single Dose Olpasiran Hepatic Impairment
Drug
Experimental Group · 1 Intervention: Olpasiran · Intervention Types: Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olpasiran
2020
Completed Phase 2
~320

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), day 15, and day 29

Who is running the clinical trial?

AmgenLead Sponsor
1,292 Previous Clinical Trials
1,326,991 Total Patients Enrolled
2 Trials studying Hepatic Impairment
66 Patients Enrolled for Hepatic Impairment
MDStudy DirectorAmgen
835 Previous Clinical Trials
896,241 Total Patients Enrolled
2 Trials studying Hepatic Impairment
66 Patients Enrolled for Hepatic Impairment

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 21st, 2021

Last Reviewed: November 14th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.