Trial results
AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
According to the results reported on ClinicalTrials.gov, this trial enrolled 235 people across three groups: 79 received a lower dose of a medicine called SIM at 75 mg, 77 received a higher dose of SIM at 125 mg, and 79 received a placebo (a dummy treatment with no active ingredient). The trial ran for about 96 weeks and was primarily measuring changes in something called MQC (a marker assessed from a liver biopsy — a small tissue sample taken from the liver) to see whether levels changed over time in each group. The reported data shows that, for the main outcome — change in MQC levels in liver tissue from the start of the trial to week 96 — the average change was −0.5 percentage points in the SIM 75 mg group, +0.5 percentage points in the SIM 125 mg group, and 0.0 percentage points in the placebo group. In other words, all three groups showed very little change from their starting levels. The reported data also shows that the percentage of participants who permanently stopped taking their study medication due to an unwanted side effect was 5.1% in the SIM 75 mg group, 7.8% in the SIM 125 mg group, and 10.3% in the placebo group. On average, participants were exposed to their study treatment for approximately 92 weeks (SIM 75 mg), 83.8 weeks (SIM 125 mg), and 87.4 weeks (placebo). The reported data also shows that laboratory test abnormalities — unexpected changes picked up in blood or other tests — were recorded across all three groups at various severity levels (mild, moderate, severe, and life-threatening), with figures ranging roughly from 7% to 49% of participants depending on the severity category and group. These figures were broadly similar across the SIM and placebo groups at most severity levels. Not all secondary outcome details were broken down further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.
View full results on ClinicalTrials.gov ↗ · Read the linked publication on PubMed (PMID 39996122) ↗
These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.
Phase 2 Primary Biliary Cholangitis Trial, Completed
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You are between 18 and 70 years old and have been diagnosed with a chronic (long-term) liver condition affecting bile flow for at least 6 months
- Your liver biopsy results (if done within the last 3 months) or a new biopsy are consistent with a condition called Primary Sclerosing Cholangitis (PSC)
- A special imaging scan of your bile ducts (called an MRCP) shows results consistent with PSC — if the scan looks normal, your biopsy must show signs of PSC instead
- Other causes of liver disease (such as viral hepatitis, alcohol-related liver disease, or other bile duct conditions) have been ruled out
- Your liver enzyme levels (AST and ALT) are not more than 10 times the upper limit of normal on lab tests
- Your kidney function blood test (creatinine) result is below 2.0 mg/dL
- If you are a woman who could become pregnant, you must have a negative pregnancy test before starting the trial
- If you are a woman who could become pregnant and are sexually active, you must agree to use an approved form of contraception during the study and for 90 days after your last dose
- If you are breastfeeding, you must agree to stop nursing before starting treatment
- If you are a man who has not had a vasectomy, you must agree to use a condom with spermicide during intercourse throughout the study and for 90 days after your last dose
Who may not be able to join:
- You are currently pregnant or breastfeeding
- Your liver disease has reached an advanced stage, shown by fluid build-up in the abdomen, confusion caused by liver failure, bleeding from swollen veins, or abnormal blood clotting results
- You have an active Hepatitis C infection
- You test positive for a Hepatitis B surface protein (HBsAg), indicating a Hepatitis B infection
- You test positive for a specific antibody (anti-mitochondrial antibody) associated with a different liver condition
- You drink more than 21 oz of alcohol per week (if male) or more than 14 oz per week (if female)
- You have a moderate to severe flare-up of ulcerative colitis, or are currently taking steroid tablets or certain biologic medications for bowel disease (confirm with trial site)
- You tested positive for amphetamines, cocaine, or non-prescribed opiates in a urine drug screen (some exceptions may apply — confirm with trial site)
- You have a significant heart condition
- You have a history of a type of bile duct cancer called cholangiocarcinoma
- You have had any other type of cancer (other than certain common skin cancers) within the past 5 years
- You have had a bile duct infection (ascending cholangitis) within the last 60 days
- You currently have a drain or stent in your bile duct
- You have had a known allergic reaction to the study drug or its ingredients
- You have had a serious bleeding problem within the last 6 months
- You are unable to attend follow-up visits or there are concerns about your ability to follow the study requirements
- You have taken part in another clinical drug or device trial within the last 30 days
- You have had major surgery within the last 30 days or currently have an open wound
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Change From Baseline in MQC on Liver Biopsy at Week 96
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.