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RNAi

Single Dose Olpasiran Normal Hepatic Function for Liver Disease

Phase 1
Waitlist Available
Research Sponsored by Amgen
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), day 15, and day 29
Awards & highlights

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
  • Liver Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), day 15, and day 29
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose, 0.5, 1, 3, 6, 9, 12, 24, 36, 48, 72, 96, 144 hours (postdose), day 15, and day 29 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
Secondary outcome measures
Area Under the Effect Time Curve (AUEC) of Plasma Lipoprotein a (Lp[a])
Maximum Inhibitory Effect (Imax) of Plasma Lp(a)
Number of Participants Who Experience an Adverse Event (AE)
+4 more

Side effects data

From 2022 Phase 2 trial • 281 Patients • NCT04270760
11%
Headache
9%
Injection site pain
7%
Myalgia
7%
COVID-19
7%
Injection site erythema
7%
Non-cardiac chest pain
7%
Immunisation reaction
5%
Injection site pruritus
5%
Oedema peripheral
5%
Pain in extremity
5%
Nausea
4%
Type 2 diabetes mellitus
4%
Constipation
4%
Arthralgia
4%
Sinusitis
4%
Abdominal pain
4%
Hypertension
4%
Gastroenteritis
4%
Fatigue
2%
Atrial fibrillation
2%
Injection site reaction
2%
Diverticulitis
2%
Seizure
2%
Syncope
2%
Diarrhoea
2%
Urinary tract infection
2%
Nasopharyngitis
2%
Dizziness
2%
Anaemia
2%
Upper respiratory tract infection
2%
Campylobacter infection
2%
Urticaria
2%
Back pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 5; Treatment Period: Placebo Q12W
Group 4; Treatment Period: Olpasiran 225 mg Q24W
Group 2; Extended Safety Follow-up Period: Olpasiran 75 mg Q12W
Group 3; Extended Safety Follow-up Period: Olpasiran 225 mg Q12W
Group 1; Extended Safety Follow-up Period: Olpasiran 10 mg Q12W
Group 1; Treatment Period: Olpasiran 10 mg Q12W
Group 2; Treatment Period: Olpasiran 75 mg Q12W
Group 3; Treatment Period: Olpasiran 225 mg Q12W
Group 4; Extended Safety Follow-up Period: Olpasiran 225 mg Q24W
Group 5; Extended Safety Follow-up: Placebo Q12W

Trial Design

2Treatment groups
Experimental Treatment
Group I: Single Dose Olpasiran Normal Hepatic FunctionExperimental Treatment1 Intervention
Participants with normal hepatic function will be enrolled and will receive a single dose of olpasiran on Day 1.
Group II: Single Dose Olpasiran Hepatic ImpairmentExperimental Treatment1 Intervention
Participants will be enrolled in 1 of 3 hepatic impairment groups based on their hepatic impairment status, as determined by Child-Pugh classification. All participants will receive a single dose of olpasiran on Day 1.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Olpasiran
2020
Completed Phase 2
~370

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

AmgenLead Sponsor
1,370 Previous Clinical Trials
1,377,663 Total Patients Enrolled
MDStudy DirectorAmgen
913 Previous Clinical Trials
924,106 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA granted its imprimatur to Single Dose Olpasiran Normal Hepatic Function?

"The safety of Single Dose Olpasiran Normal Hepatic Function is tentatively classified as a 1 due to the limited clinical evidence that exists from Phase 1 trials."

Answered by AI

Does this investigation accept seniors as participants?

"In accordance with the conditions of participation, potential participants must be at least 18 and not older than 75 years old."

Answered by AI

Is participation in this experiment available to volunteers at present?

"Affirmative. As per the information hosted on clinicaltrials.gov, this medical study is currently seeking participants and was first posted on September 13th 2022. 24 individuals are sought from four different sites for enrolment in the trial, with its last update occurring November 16th of that same year."

Answered by AI

How many subjects are being observed in this research endeavor?

"Amgen, the project's sponsor, requires 24 qualified patients to run this study. Orlando Clinical Research Center and Inland Empire Clinical Trials in Florida and California respectively are two of the main research sites for this trial."

Answered by AI

Is it possible to partake in this research study?

"All participants hoping to be admitted into this research must possess hepatic impairment and fall between the ages of 18-75. Currently, there are 24 slots open for enrollment."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment
2022. "A Study to Evaluate the Pharmacokinetics, Safety, and Pharmacodynamics of Olpasiran in Participants With Various Degrees of Hepatic Impairment". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05481411.
~10 spots leftby Apr 2025
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