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Obicetrapib for Liver Disease

Phase 1
Recruiting
Research Sponsored by NewAmsterdam Pharma
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
A male or a female of non-childbearing potential
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168
Awards & highlights

Study Summary

This trial looks at how safe and effective a drug is for people with moderate liver problems, compared to healthy people.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not detailed here but generally could include reactions related to drug metabolism changes due to hepatic impairment, such as gastrointestinal disturbances, fatigue, or allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have moderate liver problems not caused by a current liver disease.
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I am either a man or a woman who cannot become pregnant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168 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 curve from dosing time to last measurement (AUC (0-t)) for obicetrapib
Area under the curve from dosing time to infinity (AUC (0-inf)) for obicetrapib
Observed maximum plasma concentration (Cmax) for Obicetrapib

Trial Design

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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Obicetrapib
2022
Completed Phase 2
~440

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

NewAmsterdam PharmaLead Sponsor
14 Previous Clinical Trials
13,156 Total Patients Enrolled
VeranexUNKNOWN
1 Previous Clinical Trials
10 Total Patients Enrolled

Frequently Asked Questions

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

Is the age restriction for participation in this experiment limited to 45 years or younger?

"This trial is enrolling participants who are of mature age, ranging from 18 to 75 years old."

Answered by AI

Do I meet the criteria to partake in this medical study?

"Qualified applicants for this trial must be aged 18-75, suffer from liver disease, and the recruitment process is seeking a total of 16 participants."

Answered by AI

Can you assess the level of risk associated with Active Comparator: Healthy Subjects?

"The safety of Active Comparator: Healthy Subjects has been estimated to be 1, due to the fact that is a Phase 1 trial and so there are only scarce data affirming its efficacy and safety."

Answered by AI

Is enrollment for this research endeavor currently accessible to participants?

"This clinical trial is no longer open for recruitment, as indicated on the clinicaltrials.gov website. It was initially posted on September 18th 2023 and last updated three days later. However, there are 1097 other studies actively seeking participants currently available."

Answered by AI

Who else is applying?

What site did they apply to?
Nucleus Network
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria

Why did patients apply to this trial?

It has room for for healthy volunteers.
PatientReceived 1 prior treatment
Recent research and studies
clinicaltrials.govStudy
PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function
2023. "PK and Safety in Participants Taking Obicetrapib With Moderate Hepatic Impairment Relative to Normal Hepatic Function". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06048302.
~3 spots leftby May 2024
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