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Liver function and drug processing: a new study

NCT ID NCT05481411

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at how the drug olpasiran is processed by the body in people with mild, moderate, or severe liver problems compared to those with healthy livers. A total of 25 adults took a single dose of the drug. The goal was to understand safety and how the liver affects drug levels, not to treat a disease.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

25 people

The number who actually took part.

Started

Sep 2022

Finished

May 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female participants of nonchildbearing potential, between 18 and 75 years of age (inclusive) at the time of Screening. * Body mass index between 18.0 and 40.0 kg/m\^2 (inclusive) at the time of Screening. Participants with Normal Hepatic Function Only: • In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital signs measurements, and clinical laboratory evaluations at Screening and Check-in as assessed by the Investigator (or designee). Participants with Hepatic Impairment Only: • Child-Pugh A (Group 2), B (Group 3), or C (Group 4) classification defined by both Screening (to determine participant group) and Check-in (to confirm participant group prior to dosing) clinical laboratory values and physical examination findings. Exclusion Criteria: * History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee). * Estimated glomerular filtration rate \< 60 mL/min/1.73m\^2 (Groups 1-3) or \< 50 mL/min/1.73m\^2 (Group 4 only) by Modification of Diet in Renal Disease formula at Screening or Check-in. * Receiving or has received any investigational drug within the 30 days or 5 half-lives (whichever is longer) before receiving olpasiran. * Participants who were previously exposed to olpasiran. * Female participants with a positive pregnancy test at Screening or Check-in. Participants with Normal Hepatic Function Only: * Positive hepatitis panel. Participants whose results are compatible with prior immunization may be included. * Alanine aminotransferase and aspartate aminotransferase elevations \> 3x upper limit of normal at Screening or Check-in. Participants with Hepatic Impairment Only: * Positive for hepatitis B surface antigen. Participants with positive hepatitis B core antibody may be included if hepatitis B surface antigen is negative. Participants with positive hepatitis B surface antibody may be included (consistent with prior vaccination). * Active malignancy of any type. Participants with a history of malignancy that has been eradicated with supporting medical documentation indicating that there is no residual malignancy detected in the past 2 years will be allowed. * Values outside the normal range for liver function tests that are not consistent with their hepatic condition, as determined by the Investigator (or designee).

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Inland Empire Clinical Trials, LLC

    Rialto, California, 92377, United States

  • Orlando Clinical Research Center

    Orlando, Florida, 32809, United States

  • The Texas Liver Institute, Inc.

    San Antonio, Texas, 78215, United States

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