LIVDELZI was studied in a 12-month clinical trial in 193 people with PBC
![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}
Comparing results from people taking LIVDELZI with those taking placebo, the main goal of the clinical trial was to see if LIVDELZI helped people improve 3 key PBC lab results at 12 months:
- ALP levels less than 1.67 x the upper limit of normal (ULN)
- A decrease in ALP levels of at least 15% from start of trial
- Normal bilirubin levels
Other goals of the clinical trial were to determine if LIVDELZI could help:
- Lower ALP levels over 12 months
- Achieve normal ALP levels (ALP less than or equal to ULN)
- Reduce itch in people with
Numerical Rating Scale (NRS)
scores of 4 or higher at 6 months
Significantly more people who took LIVDELZI (62%) saw all 3 key PBC lab results improve at 1 year compared with people who took placebo (20%)
About 6 in 10 people
help lower your ALP
LIVDELZI lowered ALP levels at 1 month and kept them lower at the 1-year mark
36% average
ALP reduction at 30 days
(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)
Itch improvement at
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).
The NRS is a scale of 0 to 10 that measures itch severity, with 0 being no itch and 10 being the worst possible itch. 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).
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.