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 tested an investigational drug called PLN-74809 across four different dose levels, compared against a placebo (a dummy treatment with no active ingredient). A total of 121 people took part — 30 in the placebo group and 91 across the four dose groups. The trial's main focus was on tracking unwanted medical events (called adverse events) that occurred or got worse after participants started taking the study drug or placebo. A secondary focus was measuring how much of the drug was present in participants' blood at certain time points. The reported data shows that, when it came to general adverse events, 21 out of 30 people in the placebo group experienced one, compared to 10, 16, 15, and 23 out of 24, 20, 20, and 27 people respectively across the four PLN-74809 dose groups. For serious adverse events — defined as events involving hospitalisation, life-threatening situations, lasting disability, or similarly significant medical concerns — one person each in the placebo group, dose level 1, dose level 2, and dose level 4 groups experienced one, while no one in dose level 3 did. Regarding blood levels of the drug two hours after a dose, the reported data shows higher concentrations at higher dose levels: approximately 639, 843, 2,036, and 3,668 nanograms per millilitre (a standard unit for measuring substance concentration in blood) at weeks 12 for the four dose groups respectively. Data at week 24 was only reported for the highest dose group, at around 3,584 nanograms per millilitre; figures for the other dose groups at that time point were not reported in the data. The trial also tracked a liver scarring (fibrosis) score called the ELF score — a blood test where a higher number indicates more severe disease. The reported data shows that at week 12, the average change from the starting score was +0.42 in the placebo group and ranged from +0.09 to +0.19 across the PLN-74809 dose groups. At week 24, only the placebo group (+0.14) and the highest dose group (+0.19) had data reported; figures for the other dose groups were not reported in the 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 41016442) ↗
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 have been diagnosed with a specific type of bile duct disease called large duct PSC, confirmed by a specialist imaging scan of the bile ducts
- There is evidence of some liver scarring (fibrosis), shown by a scan, a blood test score, or a previous liver biopsy — but not full scarring (cirrhosis)
- Your ALP blood test result is at or above the normal range (confirm with trial site)
- Your AST and ALT blood test results are not more than 5 times higher than the normal upper limit
- If you are being treated for inflammatory bowel disease (IBD), your dose has been stable since before the study screening and is expected to stay the same throughout the study
- If you are taking a medication called UDCA, your dose must be below a certain level and must have been stable for at least 3 months before screening
Who may not be able to join:
- You have another cause of liver disease, such as liver disease caused by a virus, alcohol, or a metabolic condition
- You have, or are suspected to have, a liver condition called autoimmune hepatitis alongside your PSC
- You have a form of PSC that only affects the small bile ducts, with no involvement of the large bile ducts
- You have advanced liver scarring (cirrhosis), or signs of serious liver problems such as yellowing of the skin, fluid build-up in the abdomen, bleeding from veins, or confusion caused by liver failure
- Your ALP blood test result is more than 10 times higher than the normal upper limit
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.
Contact this trial
Principal Investigator: Pliant Therapeutics Medical Monitor, Pliant Therapeutics, Inc.
Australian sites
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
7 site(s) in Australia. Confirm current status and contact details directly with the trial site.
Primary endpoints
Number of Participants With Treatment Emergent Adverse Events; Number of Participants With Serious Treatment Emergent Adverse Events
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.