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Peptide

Aldafermin for Primary Sclerosing Cholangitis (ALPINE-PSC Trial)

Phase 2 & 3
Recruiting
Research Sponsored by NGM Biopharmaceuticals, Inc
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of PSC based on abnormal cholangiography consistent with PSC as measured by MRCP with contrast or liver biopsy consistent with PSC
LSM by VCTE, indicative of at least F2 liver fibrosis stage
Must not have
Subjects with moderate to severe renal impairment
Clinically significant acute or chronic liver disease of an etiology other than PSC
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 96 weeks

Summary

This trial is testing a drug called aldafermin in people with Primary Sclerosing Cholangitis. It is being conducted at multiple centers and will compare the effects of aldafermin

Who is the study for?
This trial is for people with Primary Sclerosing Cholangitis, a liver condition. Participants should have at least moderate liver fibrosis, normal bilirubin levels unless they have Gilbert's Syndrome, and stable liver function tests. They must not have severe kidney or other serious liver diseases, nor recent bile duct procedures.
What is being tested?
The study is testing Aldafermin against a placebo to see if it helps with Primary Sclerosing Cholangitis. It's conducted across multiple centers where participants are randomly assigned to receive either the actual drug or a dummy drug without knowing which one they get.
What are the potential side effects?
While specific side effects of Aldafermin aren't listed here, common ones may include gastrointestinal symptoms like nausea or diarrhea, potential allergic reactions, and changes in blood tests related to liver function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My liver condition was confirmed by special imaging tests or a liver biopsy.
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My liver has been diagnosed with stage F2 fibrosis or higher.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My kidneys do not work well.
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I do not have liver disease caused by PSC.
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I have moderate to severe liver problems.
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I had a bile duct stent or drain placed within the last 3 months.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 96 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Fibrosis Biomarkers, eg, the Enhanced Liver Fibrosis (ELF) score

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: aldaferminExperimental Treatment1 Intervention
Aldafermin 3mg given subcutaneously, daily, for up to 6 years
Group II: placeboPlacebo Group1 Intervention
Placebo given subcutaneously, daily, for up to 6 years
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
aldafermin
2020
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

NGM Biopharmaceuticals, IncLead Sponsor
24 Previous Clinical Trials
2,236 Total Patients Enrolled
~200 spots leftby Dec 2028
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