What side effects are associated with this type of intervention?

Common treatments for liver disease include ursodeoxycholic acid (UDCA), fibrates, and statins. UDCA is generally well-tolerated but can cause diarrhea and weight gain. Fibrates, such as fenofibrate, may lead to gastrointestinal disturbances and elevated liver enzymes. Statins are associated with muscle pain, liver enzyme abnormalities, and, rarely, severe liver injury. For CETP inhibitors like Obicetrapib, potential side effects include injection-site reactions and immunogenicity issues, as seen with other drugs in this class.

What prior FDA approvals exist?

The FDA has approved several treatments for liver diseases, particularly for primary biliary cholangitis (PBC). Ursodeoxycholic acid (UDCA) is a first-line treatment for PBC. For patients with an incomplete response to UDCA, obeticholic acid has been approved as a second-line therapy. Additionally, fibrates such as bezafibrate and fenofibrate, although not FDA-approved specifically for PBC, have shown efficacy in combination with UDCA in clinical trials. Statins are also used to manage hypercholesterolemia in liver disease patients. While Obicetrapib, a CETP inhibitor, is being studied, it is not yet FDA-approved for liver disease treatment.

What other types of research exist?

Promising novel alternatives to Obicetrapib for liver disease patients include: 1) Gemigliptin, a dipeptidyl peptidase-IV inhibitor, which has shown efficacy in improving hepatic steatosis and insulin resistance by inhibiting LECT2 expression through AMPK-dependent and JNK-dependent mechanisms. 2) Entecavir, an antiviral medication, which has demonstrated long-term benefits in reversing fibrosis/cirrhosis and improving histological outcomes in chronic hepatitis B patients. These alternatives offer potential therapeutic benefits for liver disease patients in 2024.

← Back to Search

Other

Obicetrapib for Liver Disease

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 below

Select...

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

Select...

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.

Select...

I am using a form of hormonal birth control.

Select...

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

Select...

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

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

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 • NCT04753606

Arthralgia

Lumbar spinal stenosis

Inflammation

Tendonitis

Temporomandibular joint syndrome

Somnolence

Arthropod sting

Glaucoma

Renal impairment

Headache

Cardiomegaly

Fatigue

100%

80%

60%

40%

20%

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

0 / 6Eligibility criteria met

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.