Obicetrapib for Liver Disease

Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: NewAmsterdam Pharma

No Placebo Group

Trial Summary

What is the purpose of this trial?This trial is testing obicetrapib to see how it is processed and if it is safe in people with moderate liver problems compared to healthy individuals.

Eligibility Criteria

This trial is for adults who can consent to study procedures. Women must not be able to bear children or have a negative pregnancy test if they can. Participants should have a BMI of 17.5-42 kg/m2 and weigh over 50 kg (110 lb). Cohort 1 includes those with moderate liver disease, while Cohort 2 consists of healthy volunteers without liver issues.

Inclusion Criteria

I have moderate liver problems not caused by a current liver disease.

I am either a man or a woman who cannot become pregnant.

Exclusion Criteria

I haven't taken specific strong medications or supplements in the last 12 days.

I am using a form of hormonal birth control.

I haven't donated blood (except plasma) of about 1 pint in the last 60 days.

I have or had HIV, hepatitis B, or hepatitis C.

Treatment Details

The trial tests the safety and how the body processes a single oral dose of obicetrapib (10 mg) in patients with moderate liver impairment compared to healthy individuals.

2Treatment groups

Experimental Treatment

Active Control

Group I: Active Comparator: Healthy SubjectsExperimental Treatment1 Intervention

Healthy volunteers will be matched with impaired hepatic function patients

Group II: Active Comparitor: Subjects with Moderate Hepatic ImpairmentActive Control1 Intervention

8 patients with hepatic impairment of moderate Child Pugh Category