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CompletedNCT06048302Updated Sep 19, 2024

PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function

A Phase 1 interventional study of Obicetrapib in Hepatic Impairment and Healthy, sponsored by NewAmsterdam Pharma. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-19.

Sponsored by NewAmsterdam Pharma · Phase 1, Interventional, and Other

From the registry’s dates

  • Primary completion was Mar 2024, 2 years 6 months ago, and no results have been posted to the registry.
Phase
Phase 1
Study type
Interventional
Enrollment
18
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

To investigate the safety and pharmacokinetics in patients with moderate hepatic impairment compared to healthy participants after a single oral dose of obicetrapib (10 mg).

Read the detailed description

This is a Phase 1, open-label, single-dose, parallel-group study to evaluate the plasma PK and safety of obicetrapib in participants with moderate hepatic impairment relative to participants with normal hepatic function. The purpose of the study is to investigate the effect of moderate hepatic impairment on obicetrapib PK and safety in otherwise healthy participants after a single oral 10 mg dose of obicetrapib.

02

Conditions studied

  • Hepatic Impairment
  • Healthy

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03

In context

Liver Diseases

2,081 studies on the registry are indexed under Liver Diseases; 390 are open to participants now.

This study's enrollment of 18 is below the median of 50 across 1,323 interventional studies indexed under Liver Diseases.

Browse Liver Diseases studies →

Lead sponsor

NewAmsterdam Pharma is the lead sponsor of 20 studies on the registry; 3 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 8 (62%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • A male or a female of non-childbearing potential.
  • Women of childbearing potential (WOCBP) must have a negative serum beta-human chorionic gonadotropin (β-hCG) pregnancy test at the Screening Visit.
  • Body mass index (BMI) of 17.5 to 42 kg/m2; with a total body weight >50 kg (110 lb).
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
  • Willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Cohort 1: Meet the criteria for Class B (moderate hepatic impairment) of the modified CPC. A diagnosis of hepatic dysfunction due to hepatocellular disease (and not secondary to any acute ongoing hepatocellular process) documented by medical history, physical examination (PE), liver biopsy, hepatic ultrasound, computerized tomography scan, or magnetic resonance imaging.
  • Cohort 2: Will only enroll healthy volunteers with no hepatic impairment. "Healthy" is defined as no clinically relevant abnormalities identified by a detailed medical history, complete PE (including blood pressure [BP] and pulse rate measurement), 12-lead ECG or clinical laboratory tests performed during Screening.

Exclusion criteria

Exclusion Criteria:

  • Any condition possibly affecting drug absorption (e.g., gastrectomy). Uncomplicated cholecystectomy is allowed.
  • History of or current positive results for human immunodeficiency virus (HIV) infection, hepatitis B virus (HBV) or hepatitis C virus (HCV), including hepatitis B surface antigen (HbsAg) or hepatitis C Virus antibody (HCVAb).
  • Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the Investigator's judgment, make the participant inappropriate for participation in the study.
  • Participants with an estimated glomerular filtration rate (eGFR) value of ≤30 mL/min/1.73 m2, based on the 2021 Chronic Kidney Disease Epidemiology Collaboration equation during Screening. A single repeat assessment is permitted to assess eligibility, if needed.
  • Previous administration of drugs or supplements known to be strong inducers or inhibitors of CYP3A4 within 7 days of planned dosing of obicetrapib on Day 1.
  • Concurrent use of drugs or supplements that are known substrates of CYP3A that have narrow therapeutic indices (e.g., alfentanil, cyclosporine, dihydroergotamine, ergotamine, fentanyl including transdermal patch, pimozide, quinidine, sirolimus, tacrolimus) within 12 days prior to planned dosing of obicetrapib on Day 1.
  • Participants on oral contraceptives and hormonal based contraceptives including implantable, intrauterine, intravaginal, transdermal or injectable form.
  • Previous administration of an investigational drug within 30 days (or as determined by the local requirement) or within 5 half-lives of that investigational drug, prior to planned dosing of obicetrapib on Day 1.
  • Known hypersensitivity to obicetrapib or its excipients.
  • A positive urine drug test. Participants with moderate hepatic impairment (Cohort 1) will be eligible to participate if their urine drug test is positive with a drug for a prescribed condition that is not expected to interfere with the PK of obicetrapib. Positive urine drug tests for tetrahydrocannabinol (THC) will be allowed as long as the volunteer agrees to abstain from ingesting any THC-containing products for the duration of the study (including Out patient visits up to Day 28).
  • Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 60 days prior to planned dosing of obicetrapib on Day 1.
  • History of sensitivity to heparin or a history of heparin-induced thrombocytopenia.
  • Unwilling or unable to comply with the criteria in the Lifestyle considerations listed in the protocol.
05

Study design

Phase
Phase 1
Primary purpose
Other
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    Active Comparitor: Subjects with Moderate Hepatic Impairment

    8 patients with hepatic impairment of moderate Child Pugh Category

    Drug: Obicetrapib

  • Other
    Active Comparator: Healthy Subjects

    Healthy volunteers will be matched with impaired hepatic function patients

    Drug: Obicetrapib

Interventions

  • DrugObicetrapib

    1 single dose of obicetrapib

    Also known as: 10 mg tablet

06

What researchers measure

Primary outcomes

  1. Area under the curve from dosing time to infinity (AUC (0-inf)) for obicetrapib

    Blood samples collected

    Time frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168

  2. Area under curve from dosing time to last measurement (AUC (0-t)) for obicetrapib

    Blood Sample Collected

    Time frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168

  3. Observed maximum plasma concentration (Cmax) for Obicetrapib

    Blood Sample Collected

    Time frame: 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168

07

Study locations

2 sites
  • Nucleus Network
    Saint Paul, Minnesota 55114, United States
  • The American Research Corporation
    San Antonio, Texas 78215, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06048302
Lead sponsor
NewAmsterdam Pharma
Collaborators
Veranex
Responsible party
Sponsor
First posted
Sep 21, 2023
Start date
Nov 30, 2023
Primary completion
Mar 12, 2024
Completion
Mar 19, 2024
Last update
Sep 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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