Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2a, Double-Blind, Randomized, Active Controlled, Parallel Group Study Evaluating the Efficacy, Safety, and Tolerability of Bezafibrate Administered in Combination with Obeticholic Acid in Subjects with Primary Biliary Cholangitis

This research study is for people with a liver condition called primary biliary cholangitis (PBC). The study wants to find out if combining two existing medicines, bezafibrate and Ocaliva (obeticholic acid), works better than Ocaliva alone. We are looking to see if this combination helps improve liver health, specifically by checking a liver enzyme called ALP (alkaline phosphatase). Researchers will also be checking for side effects to make sure the treatment is safe and well-tolerated. This is a "Phase 2" study, meaning it's still in the earlier stages of testing to see if the treatment has a positive effect and is worth further investigation. Participants will receive either Ocaliva alone or Ocaliva with bezafibrate, but they won't know which one they are getting.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Intercept Pharmaceuticals Inc.

Enrolment target

Start

29 Jul 2024

Primary biliary cholangitis

What is this study about?

This study is for people who have a long-term liver condition called primary biliary cholangitis, or PBC. In PBC, the small bile ducts in the liver are slowly destroyed. Bile is a fluid that helps digest fats, and when the ducts are damaged, bile can build up in the liver, causing issues over time. We are investigating whether giving two medicines together, bezafibrate and Ocaliva (which contains the active ingredient obeticholic acid), could be a more effective way to help people with PBC.

The main goal of this study is to see how much a specific liver enzyme, called ALP (alkaline phosphatase), changes in people taking the combination treatment compared to those taking Ocaliva alone. ALP levels often go up when the liver isn't working as it should, so a drop in ALP can mean the liver is improving. We hope to see a significant improvement in ALP levels after 12 weeks of treatment.

Beyond ALP, the study will also look at how safe the treatment is and if people can take it without too many side effects. We will monitor other liver tests, like GGT, ALT, and AST, and check for changes in bilirubin and cholesterol levels. All these measurements help us understand how the liver is responding to the treatment and if it's generally good for your health. This valuable information will help doctors understand if this combination treatment could be a better option for people living with PBC in the future.

Key takeaways

This study is testing a new combination treatment for primary biliary cholangitis (PBC).
It aims to see if bezafibrate and Ocaliva together improve liver health more than Ocaliva alone.
The main focus is on changes in a liver enzyme called ALP.
The study also carefully checks for safety and side effects.
It's a 12-week study, and participants won't know which exact treatment they are receiving.
Joining is voluntary, and you can leave at any time.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women. The researchers want to include a wide range of people with primary biliary cholangitis to get a good understanding of how the treatment works.

There might be other specific health conditions or medications that would prevent you from joining, but the general criteria are quite broad. The doctors running the study will check if you meet all the requirements to make sure it's safe and appropriate for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with primary biliary cholangitis (PBC)?
Are you able to attend regular clinic appointments for 12 weeks?
Are you comfortable with taking study medication and having blood tests?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be assigned to one of two groups by chance, like flipping a coin. One group will take Ocaliva film-coated tablets along with bezafibrate, and the other group will take Ocaliva tablets with a dummy pill (placebo) instead of bezafibrate. You and your doctor won't know which treatment you are receiving until the study is over. You will have regular visits to the clinic over 12 weeks. At these visits, doctors will take blood samples to check your liver function and general health, and they will ask you about any side effects you might be experiencing. They will also do physical examinations. Before the study begins, and at the end, there will be assessments to get a full picture of your health. The total duration of active treatment and monitoring is 12 weeks.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that the combination treatment might be more effective at improving your liver health than current treatments. However, there's no guarantee, and the combination could also cause side effects, some of which might be unpleasant or unexpected. The doctors and nurses will monitor you very closely for any side effects and will be there to answer your questions. You always have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is primary biliary cholangitis (PBC)?

PBC is a long-lasting liver disease where the tiny bile ducts in the liver get damaged over time. This can cause bile to build up, which can harm the liver.

Why are you studying two medicines together?

We are trying to see if combining two existing medicines, bezafibrate and Ocaliva, works better to improve liver health compared to Ocaliva on its own.

What does 'Phase 2a' mean for a study?

Phase 2a means this is an earlier stage of testing a new treatment. We are looking to see if the treatment has a positive effect and is safe enough to study in more people later.

Will I know which treatment I am getting?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you are getting bezafibrate or a dummy pill along with Ocaliva.

How long will I be in the study?

The active part of the study, including treatment and monitoring, will last for 12 weeks.