Phase 2 Primary Biliary Cholangitis Trial, Completed NCT02704364 Sponsor: NGM Biopharmaceuticals, Inc Condition: Primary Biliary Cholangitis
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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 looked at a drug called NGM282 in people with a liver condition called Primary Sclerosing Cholangitis (PSC), which causes scarring of the bile ducts. A total of 62 people took part — 21 received a lower dose of NGM282 (1.0 mg), 21 received a higher dose (3.0 mg), and 20 received a placebo (a dummy treatment with no active ingredient). The trial mainly measured changes in a liver enzyme in the blood called alkaline phosphatase, which doctors often monitor in people with PSC. It also tracked several other liver-related substances in the blood. The reported data shows that for the main measure — the average change in alkaline phosphatase levels from the start of the trial — the 1.0 mg group saw an average increase of 25.6 units per litre, the 3.0 mg group saw an average decrease of 9.8 units per litre, and the placebo group saw an average decrease of 0.6 units per litre. In percentage terms, these changes were +7.1%, −4.2%, and −3.4% respectively. For two other liver enzymes (AST and ALT), the reported data shows the 3.0 mg group had larger average decreases compared to the 1.0 mg group and the placebo group, though the numbers varied across the two enzymes. For bilirubin (a substance that builds up when the liver is under stress), the 1.0 mg group showed a notable average increase, while the 3.0 mg and placebo groups showed only very small average changes. The rate-of-change data for alkaline phosphatase over time was only reported for the two NGM282 groups and was not reported for the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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

NCT02704364
Completed Phase 2

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 condition called Primary Sclerosing Cholangitis (PSC), which is a disease that causes scarring and narrowing of the bile ducts in the liver.

Who may not be able to join:

  • You have a significant liver disease caused by something other than PSC.
  • Your bile duct condition is caused by a different but similar disease, either "secondary sclerosing cholangitis" or a condition related to a protein called IgG4 (confirm with trial site).

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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Trial details

Status
Completed
Phase
Phase 2
Sponsor
NGM Biopharmaceuticals, Inc
Registry
ClinicalTrials.gov
Start date
1 March 2016
Est. completion
1 June 2017

Where this trial is recruiting

🇫🇷 France 🇳🇱 Netherlands 🇬🇧 United Kingdom 🇺🇸 United States

Primary endpoints

Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis

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Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov