LIVDELZI clinical
trial results
Ask your healthcare provider if LIVDELZI is right for you.
In the clinical trial, LIVDELZI significantly improved key primary biliary cholangitis (PBC) lab results and reduced both alkaline phosphatase (ALP) and itch.
In the clinical trial, LIVDELZI significantly improved key primary biliary cholangitis (PBC) lab results and reduced both alkaline phosphatase (ALP) and itch.
Who participated in the clinical trial?
![Icon representing the LIVDELZI® (seladelpar) arm [or group]](-/media/affinity/livdelzipatient/icons/livdelzi-results/img-desktop-livdelzi-results-three-green-people.svg){kind=icon}
![Icon representing the placebo arm [or group]](-/media/affinity/livdelzipatient/icons/livdelzi-results/img-desktop-livdelzi-results-three-gray-people.svg){kind=icon}
What did clinical researchers aim to find?
Researchers wanted to see if LIVDELZI was more effective than placebo at improving the following 3 key liver lab results after 12 months:
- ALP levels less than 1.67x the top of the normal range
- A decrease in ALP levels of at least 15% from start of trial
- Achieve normal bilirubin levels
Researchers also evaluated LIVDELZI vs placebo to see if it was more effective in 3 other key goals:
- Lower ALP levels over 12 months
- Achieve normal ALP levels (ALP at or below the top of the normal range)
- Reduce itch in people with Numerical Rating Scale (NRS) scores of 4 or higher at 6 months
LIVDELZI improved key PBC lab results in significantly more people at 1 year vs placebo
with or without ursodiol
vs
with or without ursodiol
LIVDELZI lowered ALP levels at 1 month and kept them lower at the 1-year mark
36% average
ALP reduction at 30 days with LIVDELZI
(vs 5% for placebo)
People taking LIVDELZI experienced
42% average ALP reduction at 1 year
(vs 4% for placebo)
1 in 4 people (25%) taking LIVDELZI reached
normal ALP levels at 1 year
(vs none taking placebo)
“Seeing my numbers go down was encouraging. On LIVDELZI, my ALP came down closer to normal.”
Angela
Real LIVDELZI patient
Person featured is compensated by Gilead.
![Icon representing the LIVDELZI® (seladelpar) arm [or group]](/-/media/Affinity/LivdelziPatient/Icons/Common/icon-desktop-how-livdelzi-works-user.svg){kind=icon}
![Icon representing the LIVDELZI® (seladelpar) arm [or group]](/-/media/Affinity/LivdelziPatient/Icons/Common/icon-desktop-how-livdelzi-works-magnifying-glass.svg){kind=icon}
![Icon representing the LIVDELZI® (seladelpar) arm [or group]](/-/media/Affinity/LivdelziPatient/Icons/Common/icon-desktop-how-livdelzi-works-bottle.svg){kind=icon}
Itch improvement in 1 month, with significant improvement at 6 months—a first in PBC
People who began the trial with NRS scores ≥4 saw:
Rapid itch improvement
LIVDELZI started improving itch at 30 days.
Significant itch improvement
At 6 months, people taking LIVDELZI experienced an average itch reduction from the start of the trial of about 52% vs 26% for those taking placebo (a 3.2-point decrease on the NRS vs a 1.7-point decrease for placebo). Itch reduction was maintained from months 6 to 12.
The NRS, or Numerical Rating Scale, measures itch from 0 to 10, with 0 being no itch and 10 being the worst possible itch. In LIVDELZI clinical studies, people recorded itch regularly to track how much it improved.
People evaluated in the trial who already had itch began the trial with NRS scores of ≥4; the average NRS score at the start of the trial was 6.1 for LIVDELZI (49 people) and 6.6 for placebo (23 people).
It’s important to make sure your healthcare team knows about any symptoms you are experiencing, including itch. They may be able to adjust your treatment plan to try and manage your symptoms.
Since itch can come and go, even if you aren’t experiencing itch during your appointment, it’s important to share how itch affects your day-to-day life.
You can use the NRS as part of your notes to help describe symptoms to your healthcare provider.
Tap for Important Safety Information, including serious side effects for bone fractures and changes in liver tests.
What is LIVDELZI?
LIVDELZI is a prescription medicine used to treat primary biliary cholangitis (PBC) in combination with ursodeoxycholic acid (UDCA) in adults who have not responded well to UDCA, or used alone in patients unable to tolerate UDCA.
LIVDELZI is not recommended for use in people who have advanced liver disease (decompensated cirrhosis). Symptoms of advanced liver disease may include confusion; having fluid in the stomach area (abdomen); black, tarry, or bloody stools; coughing up or vomiting blood; or having vomit that looks like “coffee grounds”.
It is not known if taking LIVDELZI will improve your chance of survival or prevent liver decompensation.
It is not known if LIVDELZI is safe and effective in children.
Important Safety Information
What are the possible side effects of LIVDELZI?
LIVDELZI can cause serious side effects, including:
- Bone fractures. Taking LIVDELZI may increase your risk of bone fractures. Tell your healthcare provider about any bone fractures, or if you develop pain, or have changes in your ability to move around.
- Changes in liver tests. Increased liver enzymes in the blood have happened when taking more LIVDELZI than prescribed. Your healthcare provider will do tests to check your liver before you start and during treatment with LIVDELZI.
Tell your healthcare provider right away if you have any of the following signs or symptoms of worsening liver problems during treatment with LIVDELZI:
- swelling of your stomach area (abdomen) from a build-up of fluid
- yellowing of your skin or the whites of your eyes
- pain on the right side of your stomach (abdomen)
- black, tarry, or bloody stools
- coughing up or vomiting blood, or your vomit looks like “coffee grounds”
- mental changes such as confusion, being sleepier than usual or harder to wake up, slurred speech, mood swings, or changes in personality
The most common side effects of LIVDELZI include headache, stomach (abdominal) pain, nausea, abdominal swelling (distension), and dizziness.
Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of LIVDELZI.
What should I tell my healthcare provider before taking LIVDELZI?
Tell your healthcare provider about all of your medical conditions, including if you:
- have advanced liver disease.
- think you may have a blockage of the bile ducts in your liver (biliary obstruction).
- are pregnant or plan to become pregnant. It is not known if LIVDELZI will harm your unborn baby.
- Pregnancy safety study. If you become pregnant while taking LIVDELZI, tell your healthcare provider right away. There is a pregnancy safety study for women who take LIVDELZI during pregnancy. Talk to your healthcare provider about providing information to the LIVDELZI pregnancy safety study. The purpose of this pregnancy safety study is to capture information about your health and your baby’s health. You or your healthcare provider can report your pregnancy by calling 1-800-445-3235.
- are breastfeeding or plan to breastfeed. It is not known if LIVDELZI passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you take LIVDELZI.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. LIVDELZI can affect the way certain medicines work. Certain other medicines may affect the way LIVDELZI works.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
Please see Important Facts about LIVDELZI.