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Obicetrapib for Liver Disease
Saint Paul, MN
Phase 1
Waitlist Available
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
Must not have
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
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
No Placebo-Only Group
Summary
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.
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.
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.
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 belowSelect...
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.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I haven't taken specific strong medications or supplements in the last 12 days.
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I am using a form of hormonal birth control.
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I haven't donated blood (except plasma) of about 1 pint in the last 60 days.
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I have or had HIV, hepatitis B, or hepatitis C.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0 (pre-dose), 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48, 72, 120, 168
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
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
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
Side effects data
From 2021 Phase 2 trial • 120 Patients • NCT047536063%
Inflammation
3%
Tendonitis
3%
Temporomandibular joint syndrome
3%
Lumbar spinal stenosis
3%
Arthralgia
3%
Somnolence
3%
Arthropod sting
3%
Glaucoma
3%
Renal impairment
3%
Headache
3%
Cardiomegaly
3%
Fatigue
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Obicetrapib 10 mg
Obicetrapib 5 mg
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
2024
Completed Phase 3
~3370
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for liver disease, such as CETP inhibitors like Obicetrapib, work by increasing HDL cholesterol and lowering LDL cholesterol, which helps manage lipid levels. Statins inhibit HMG-CoA reductase to reduce cholesterol synthesis, while ursodeoxycholic acid (UDCA) improves bile flow and reduces liver inflammation.
These mechanisms are vital for liver disease patients as they help control cholesterol levels, reduce liver damage, and improve liver function, ultimately enhancing patient outcomes.
Pharmacotherapies that specifically target ammonia for the prevention and treatment of hepatic encephalopathy in adults with cirrhosis.UPDATE OF THE BRAZILIAN SOCIETY OF HEPATOLOGY RECOMMENDATIONS FOR DIAGNOSIS AND MANAGEMENT OF AUTOIMMUNE DISEASES OF THE LIVER.Lecithin: cholesterol-acyltransferase (LCAT) activity in alcoholic liver disease.
Pharmacotherapies that specifically target ammonia for the prevention and treatment of hepatic encephalopathy in adults with cirrhosis.UPDATE OF THE BRAZILIAN SOCIETY OF HEPATOLOGY RECOMMENDATIONS FOR DIAGNOSIS AND MANAGEMENT OF AUTOIMMUNE DISEASES OF THE LIVER.Lecithin: cholesterol-acyltransferase (LCAT) activity in alcoholic liver disease.
Find a Location
Closest Location:Nucleus Network· Saint Paul, MN
Logistics
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
NewAmsterdam PharmaLead Sponsor
16 Previous Clinical Trials
13,878 Total Patients Enrolled
VeranexUNKNOWN
3 Previous Clinical Trials
58 Total Patients Enrolled