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CompletedNCT02704364Updated Jun 17, 2025Results posted

A Study of NGM282 in Patients With Primary Sclerosing Cholangitis

A Phase 2 interventional study of NGM282 and Placebo in Primary Sclerosing Cholangitis, sponsored by NGM Biopharmaceuticals, Inc. Completed at 38 sites in 4 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-06-17.

Sponsored by NGM Biopharmaceuticals, Inc · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 74 studies in Cholangitis, Sclerosing with a site in United States — 18 open to participants now, 21 under way, 2 of them phase 3. Cholangitis, Sclerosing · United States.

Enrollment
19th of 56
62 · median 28
Started
2016
with 6 others
Phase 2
25 of 74
5 open now
Registered
30th of 74
by date

Among the 74 studies in Cholangitis, Sclerosing with a site in United States, this one is the 19th largest by enrollment of the 56 interventional ones that give a count, is one of 7 that started in 2016, is one of 25 in phase 2, and was the 30th registered.

Cholangitis, Sclerosing

149 studies on the registry are indexed under Cholangitis, Sclerosing; 39 are open to participants now.

Browse Cholangitis, Sclerosing studies →

Open to participants now

18 of the 74 studies in Cholangitis, Sclerosing with a site in United States are open now. Recruiting first, the newest first:

13 more — sign in →

All 18 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 30 Cholangitis, Sclerosing studies recruiting now, 12 (40%) set no upper age limit and 13 (43%) stop at 75 or younger; 9 take children under 18; 9 take healthy volunteers.

This study: 18 Years to 75 Years · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 74 studies in Cholangitis, Sclerosing with a site in United States, or all of them as a file.
02

Study summary

The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in patients with Primary Sclerosing Cholangitis.

03

Conditions studied

  • Primary Sclerosing Cholangitis
04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Confirmed diagnosis of PSC

Exclusion criteria

Exclusion Criteria:

  • acute or chronic liver disease of an etiology other than PSC
  • Secondary or IgG4 related sclerosing cholangitis
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
62 participants (actual)

Study arms

  • Experimental
    NGM282 Dose 1

    NGM282 Dose 1

    Biological: NGM282

  • Experimental
    NGM282 Dose 2

    NGM282 Dose 2

    Biological: NGM282

  • Active comparator
    Placebo

    Placebo

    Other: Placebo

Interventions

06

What researchers measure

Primary outcomes

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

    Blood samples were collected to assess changes in alkaline phosphatase levels.

    Time frame: Baseline to Week 12

Secondary outcomes

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

    Blood samples were collected to assess changes in alkaline phosphatase levels.

    Time frame: Baseline to Week 12

  2. Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis

    Blood samples were collected to assess rate of change in alkaline phosphatase levels. Serum levels of alkaline phosphatase was measured in a central laboratory using standard enzymatic method. The unit of measure is U/L.

    Time frame: Baseline to Week 12

  3. Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis

    Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.

    Time frame: Baseline to Week 12

  4. Mean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis

    Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.

    Time frame: Baseline to Week 12

  5. Mean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis

    Blood samples were collected to assess changes in bilirubin (direct and total) levels.

    Time frame: Baseline to Week 12

  6. Mean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis

    Blood samples were collected to assess changes in bilirubin (direct and total) levels.

    Time frame: Baseline to Week 12

  7. Mean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis

    Blood samples were collected to assess changes in gamma glutamyl transferase levels.

    Time frame: Baseline to Week 12

  8. Mean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis

    Blood samples were collected to assess changes in gamma glutamyl transferase levels.

    Time frame: Baseline to Week 12

  9. Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis

    Blood samples were collected to assess changes in cholesterol levels.

    Time frame: Baseline to Week 12

  10. Mean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis

    Blood samples were collected to assess changes in cholesterol levels.

    Time frame: Baseline to Week 12

  11. Mean Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis

    Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.

    Time frame: Baseline to Week 12

  12. Mean Percent Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis

    Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.

    Time frame: Baseline to Week 12

  13. Mean Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis

    Blood samples were collected to assess changes in Prothrombin levels.

    Time frame: Baseline to Week 12

  14. Mean Percent Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis

    Blood samples were collected to assess changes in Prothrombin levels.

    Time frame: Baseline to Week 12

  15. Mean Change From Baseline in Calprotectin in Patients With Primary Sclerosing Cholangitis

    Blood samples were collected to assess changes in Calprotectin levels.

    Time frame: Baseline to Week 12

  16. Mean Change From Baseline in Enhanced Liver Fibrosis Score in Patients With Primary Sclerosing Cholangitis

    Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens). ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome. ELF is a score on a scale of severity assessment against biopsy-proven fibrosis. A score of \<7.7 is none to mild, \> 7.7-9.8 is moderate, \> 9.8 is severe.

    Time frame: Baseline to Week 12

  17. Severity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing Cholangitis

    Severity of inflammatory bowel disease (IBD)-associated symptoms and acute cholangitis are summarized with number and percentage. The partial Mayo IBD scale assesses stool frequency, rectal bleeding, and there is a Physician's global assessment. Each section is summed and remission is defined as a total score of 0-1, mild disease 2-4, moderate disease 5-6, and severe disease 7-9. Higher total scores indicate more severe disease. The number of participants are being presented based on the severity of their IBD symptoms.

    Time frame: Baseline to Week 12

07

Results

Posted Jun 17, 2025

Participant flow

A total of 62 participants who met all inclusion criteria and no exclusion criteria were randomized to receive treatment over a 12-week treatment period at 24 clinic sites in the United States, 5 sites in the United Kingdom, 5 sites in the Netherlands, and 1 site in France.

Participant flow — Overall Study
MilestoneNGM282 1.0 mgNGM282 3.0 mgPlacebo
Started212120
Completed191819
Not completed231
Withdrew: Adverse event110
Withdrew: Noncompliance with study drug110
Withdrew: Other011

Outcome measures

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

Blood samples were collected to assess changes in alkaline phosphatase levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · International units/Liter
Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
International units/LiterNGM282 1.0 mgNGM282 3.0 mgPlacebo
Mean Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis25.6 ± 100.3-9.8 ± 101.3-0.6 ± 79.5
Statistical analysis
  • NGM282 1.0 mg vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.434 · Hodges-lehmann estimate: -14.0 · 95% CI -68.0 to 28.0
  • NGM282 3.0 mg vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.646 · Hodges-lehmann estimate: 13.0 · 95% CI -41.0 to 71.0
SecondaryMean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in alkaline phosphatase levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · percent change
Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
percent changeNGM282 1.0 mgNGM282 3.0 mgPlacebo
Mean Percent Change From Baseline in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis7.1 ± 5.8-4.2 ± 5.9-3.4 ± 6.0
SecondaryMean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess rate of change in alkaline phosphatase levels. Serum levels of alkaline phosphatase was measured in a central laboratory using standard enzymatic method. The unit of measure is U/L.

Time frame:
Baseline to Week 12
Reported as:
Mean · U/L/Week
Mean Rate of Change in Alkaline Phosphatase in Patients With Primary Sclerosing Cholangitis
U/L/WeekNGM282 1.0 mgNGM282 3.0 mg
Weeks 1 through 4-17.7 ± 6.4-2.2 ± 6.1
Weeks 5 through 1211.9 ± 4.5-0.2 ± 2.2
SecondaryMean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · units/liter
Mean Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis
units/literNGM282 1.0 mgNGM282 3.0 mgPlacebo
Aspartate aminotransferase-0.2 ± 7.0-30.9 ± 7.0-13.3 ± 7.1
Alanine aminotransferase8.5 ± 10.2-45.1 ± 10.4-12.1 ± 10.5
SecondaryMean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in aspartate aminotransferase and alanine aminotransferase levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · percent change
Mean Percent Change From Baseline in Aspartate Aminotransferase and Alanine Aminotransferase in Patients With Primary Sclerosing Cholangitis
percent changeNGM282 1.0 mgNGM282 3.0 mgPlacebo
Aspartate aminotransferase2.6 ± 7.8-25.5 ± 7.9-7.2 ± 8.0
Alanine aminotransferase7.2 ± 8.1-29.2 ± 8.2-6.1 ± 8.3
SecondaryMean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in bilirubin (direct and total) levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · micromole/liter
Mean Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis
micromole/literNGM282 1.0 mgNGM282 3.0 mgPlacebo
Direct bilirubin9.14 ± 5.190.54 ± 5.300.55 ± 5.2
Total bilirubin9.78 ± 5.880.04 ± 6.010.83 ± 6.02
SecondaryMean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in bilirubin (direct and total) levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · percent change
Mean Percent Change From Baseline in Bilirubin (Direct and Total) in Patients With Primary Sclerosing Cholangitis
percent changeNGM282 1.0 mgNGM282 3.0 mgPlacebo
Direct bilirubin36.5 ± 16.75.7 ± 17.19.2 ± 17.1
Total bilirubin27.2 ± 17.9-3.6 ± 18.26.8 ± 18.2
SecondaryMean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in gamma glutamyl transferase levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · units/liter
Mean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis
units/literNGM282 1.0 mgNGM282 3.0 mgPlacebo
Mean Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis156.6 ± 45.7-20.3 ± 46.34.6 ± 46.5
SecondaryMean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in gamma glutamyl transferase levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · percent change
Mean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis
percent changeNGM282 1.0 mgNGM282 3.0 mgPlacebo
Mean Percent Change From Baseline in Gamma Glutamyl Transferase in Patients With Primary Sclerosing Cholangitis20.9 ± 10.56.6 ± 10.67.5 ± 10.6
SecondaryMean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in cholesterol levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · millimole/liter
Mean Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
millimole/literNGM282 1.0 mgNGM282 3.0 mgPlacebo
Total cholesterol0.14 ± 1.010.26 ± 1.100.15 ± 0.69
High-density lipoprotein0.04 ± 0.46-0.05 ± 0.50-0.06 ± 0.19
Low-density lipoprotein0.07 ± 0.850.30 ± 0.710.12 ± 0.54
Triglycerides0.01 ± 0.59-0.08 ± 0.370.10 ± 0.34
SecondaryMean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in cholesterol levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · percent change
Mean Percent Change From Baseline in Cholesterol Levels in Patients With Primary Sclerosing Cholangitis
percent changeNGM282 1.0 mgNGM282 3.0 mgPlacebo
Total cholesterol1.81 ± 16.455.67 ± 16.313.89 ± 12.17
High-density lipoprotein0.47 ± 28.94-0.36 ± 23.87-3.09 ± 10.42
Low-density lipoprotein1.36 ± 27.5610.63 ± 19.626.18 ± 19.15
Triglycerides3.47 ± 45.71-5.81 ± 27.2211.61 ± 33.32
SecondaryMean Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · nmol/Liter
Mean Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis
nmol/LiterNGM282 1.0 mgNGM282 3.0 mgPlacebo
Mean Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis6.4 ± 33.91.1 ± 30.60.7 ± 21.7
SecondaryMean Percent Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in 25-Hydroxyvitamin D levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · percent change
Mean Percent Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis
percent changeNGM282 1.0 mgNGM282 3.0 mgPlacebo
Mean Percent Change From Baseline in 25-Hydroxyvitamin D in Patients With Primary Sclerosing Cholangitis30.5 ± 97.317.0 ± 64.84.4 ± 41.6
SecondaryMean Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in Prothrombin levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · International normalized ratio
Mean Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis
International normalized ratioNGM282 1.0 mgNGM282 3.0 mgPlacebo
Mean Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis0.03 ± 0.090.01 ± 0.070.00 ± 0.08
SecondaryMean Percent Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in Prothrombin levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · percent change
Mean Percent Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis
percent changeNGM282 1.0 mgNGM282 3.0 mgPlacebo
Mean Percent Change From Baseline in Prothrombin International Normalized Ratio in Patients With Primary Sclerosing Cholangitis3.39 ± 8.020.65 ± 6.670.47 ± 6.75
SecondaryMean Change From Baseline in Calprotectin in Patients With Primary Sclerosing Cholangitis

Blood samples were collected to assess changes in Calprotectin levels.

Time frame:
Baseline to Week 12
Reported as:
Mean · microgram/gram
Mean Change From Baseline in Calprotectin in Patients With Primary Sclerosing Cholangitis
microgram/gramNGM282 1.0 mgNGM282 3.0 mgPlacebo
Mean Change From Baseline in Calprotectin in Patients With Primary Sclerosing Cholangitis353.4 ± 839.8211.8 ± 585.8-10.3 ± 457.9
SecondaryMean Change From Baseline in Enhanced Liver Fibrosis Score in Patients With Primary Sclerosing Cholangitis

Enhanced Liver Fibrosis (ELF) score is a non-invasive blood test derived from the measurement of hyaluronic acid (HA), amino terminal propeptide of type III procollagen (PIIINP), and tissue inhibitor of metalloprotease 1 (TIMP1) using a proprietary algorithm (Siemens). ELF score is a laboratory test, is unitless, and is used as a continuous variable. The minimal ELF score is zero, the maximal ELF score is unknown. The higher the ELF score, the worse the disease outcome. ELF is a score on a scale of severity assessment against biopsy-proven fibrosis. A score of \<7.7 is none to mild, \> 7.7-9.8 is moderate, \> 9.8 is severe.

Time frame:
Baseline to Week 12
Reported as:
Mean · units on a scale
Mean Change From Baseline in Enhanced Liver Fibrosis Score in Patients With Primary Sclerosing Cholangitis
units on a scaleNGM282 1.0 mgNGM282 3.0 mgPlacebo
Mean Change From Baseline in Enhanced Liver Fibrosis Score in Patients With Primary Sclerosing Cholangitis-0.22 ± 0.64-0.26 ± 0.660.05 ± 0.52
SecondarySeverity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing Cholangitis

Severity of inflammatory bowel disease (IBD)-associated symptoms and acute cholangitis are summarized with number and percentage. The partial Mayo IBD scale assesses stool frequency, rectal bleeding, and there is a Physician's global assessment. Each section is summed and remission is defined as a total score of 0-1, mild disease 2-4, moderate disease 5-6, and severe disease 7-9. Higher total scores indicate more severe disease. The number of participants are being presented based on the severity of their IBD symptoms.

Time frame:
Baseline to Week 12
Reported as:
Count of participants · Participants
Severity of Inflammatory Bowel Disease-Associated Intestinal Symptoms in Patients With Primary Sclerosing Cholangitis
ParticipantsNGM282 1.0 mgNGM282 3.0 mgPlacebo
Remission121317
Mild disease883
Moderate disease100
Severe disease000

Adverse events

Collected over Treatment-emergent adverse events were collected from Day 1 up to Week 16.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
NGM282 1.0 mg0/21 (0%)1/21 (4.8%)17/21 (81%)
NGM282 3.0 mg0/21 (0%)2/21 (9.5%)20/21 (95.2%)
Placebo0/20 (0%)0/20 (0%)18/20 (90%)
Most frequent serious events
Most frequent serious events
EventNGM282 1.0 mgNGM282 3.0 mgPlacebo
Bowel obstructionGastrointestinal disorders0/211/210/20
Cholangitis sclerosingHepatobiliary disorders1/210/210/20
Intervertebral discitisInfections and infestations0/211/210/20
Blood bilirubin increasedInvestigations1/210/210/20
Most frequent other events
Showing 10 of 41
Most frequent other events
EventNGM282 1.0 mgNGM282 3.0 mgPlacebo
Injection site erythemaGeneral disorders2/2111/211/20
DiarrheaGastrointestinal disorders5/214/210/20
NasopharyngitisInfections and infestations1/212/214/20
Loose stoolsGastrointestinal disorders4/212/211/20
HeadacheNervous system disorders0/214/213/20
Increased appetiteMetabolism and nutrition disorders4/211/210/20
NauseaGastrointestinal disorders2/212/213/20
FatigueGeneral disorders1/213/213/20
Increased stool frequencyGastrointestinal disorders1/213/210/20
Vitamin D deficiencyMetabolism and nutrition disorders3/211/211/20

Baseline characteristics

Baseline demographic characteristics were assessed in the Randomized Set.

Age, Categorical
Age, Categorical(Participants)NGM282 1.0 mgNGM282 3.0 mgPlaceboTotal
<=18 years0101
Between 18 and 65 years17201956
>=65 years4015
Age, Continuous
Age, Continuous(years)NGM282 1.0 mgNGM282 3.0 mgPlaceboTotal
Mean46.0 ± 15.940.2 ± 13.043.4 ± 12.443.2 ± 13.8
Sex: Female, Male
Sex: Female, Male(Participants)NGM282 1.0 mgNGM282 3.0 mgPlaceboTotal
Female79824
Male14121238
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)NGM282 1.0 mgNGM282 3.0 mgPlaceboTotal
White18181652
Black or African American1247
Asian1001
Other1102
08

Study locations

38 sites
  • NGM Clinical Study Site 118
    Sacramento, California, United States
  • NGM Clinical Study Site 112
    San Clemente, California, United States
  • NGM Clinical Study Site 127
    San Francisco, California, United States
  • NGM Clinical Study Site 106
    Aurora, Colorado, United States
  • NGM Clinical Study Site 115
    Washington, District of Columbia, United States
  • NGM Clinical Study Site 110
    Gainesville, Florida, United States
  • NGM Clinical Study Site 124
    Lakewood Ranch, Florida, United States
  • NGM Clinical Study Site 105
    Miami, Florida, United States
  • NGM Clinical Study Site 109
    Indianapolis, Indiana, United States
  • NGM Clinical Study Site 104
    Detroit, Michigan, United States
  • NGM Clinical Study Site 102
    Kansas City, Missouri, United States
  • NGM Clinical Study Site 107
    Saint Louis, Missouri, United States
  • NGM Clinical Study Site 103
    New York, New York, United States
  • NGM Clinical Study Site 116
    Durham, North Carolina, United States
  • NGM Clinical Study Site 120
    Cincinnati, Ohio, United States
  • NGM Clinical Study Site 114
    Nashville, Tennessee, United States
  • NGM Clinical Study Site 113
    Dallas, Texas, United States
  • NGM Clinical Study Site 117
    Dallas, Texas, United States
  • NGM Clinical Study Site 119
    Houston, Texas, United States
  • NGM Clinical Study Site 125
    Southlake, Texas, United States
  • NGM Clinical Study Site 111
    Charlottesville, Virginia, United States
  • NGM Clinical Study Site 122
    Newport News, Virginia, United States
  • NGM Clinical Study Site 101
    Norfolk, Virginia, United States
  • NGM Clinical Study Site 121
    Richmond, Virginia, United States
  • NGM Clinical Study Site 108
    Seattle, Washington, United States
  • NGM Clinical Study Site 126
    Seattle, Washington, United States
  • NGM Clinical Study Site 301
    Paris, France
  • NGM Clinical Study Site 402
    Amsterdam, Netherlands
  • NGM Clinical Study Site 407
    Amsterdam, Netherlands
  • NGM Clinical Study Site 406
    Leiden, Netherlands
  • NGM Clinical Study Site 401
    Nijmegen, Netherlands
  • NGM Clinical Study Site 404
    Rotterdam, Netherlands
  • NGM Clinical Study Site 405
    Utrecht, Netherlands
  • NGM Clinical Study Site 505
    Birmingham, United Kingdom
  • NGM Clinical Study Site 504
    Liverpool, United Kingdom
  • NGM Clinical Study Site 502
    London, United Kingdom
  • NGM Clinical Study Site 501
    Newcastle, United Kingdom
  • NGM Clinical Study Site 503
    Norwich, United Kingdom
09

References and documents

Publications

  • Sanyal AJ, Ling L, Beuers U, DePaoli AM, Lieu HD, Harrison SA, Hirschfield GM. Potent suppression of hydrophobic bile acids by aldafermin, an FGF19 analogue, across metabolic and cholestatic liver diseases. JHEP Rep. 2021 Feb 19;3(3):100255. doi: 10.1016/j.jhepr.2021.100255. eCollection 2021 Jun. PubMed 33898959 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Mar 2016 to primary completion in Jun 2017, 15 months.

Results were first posted in Jun 2025, 8 years after primary completion. A results delay was requested in Jul 2018.

Of 23 phase 2 interventional studies under Cholangitis, Sclerosing, half reached primary completion within 37 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 62. This study's 15 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 29, 2016
First posted
Mar 10, 2016
StartActual
Mar 2016
Primary completionActual
Jun 2017
CompletionActual
Jun 2017
Results delay requested
Jul 16, 2018
Results first posted
Jun 17, 2025
Last update
Jun 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02704364
Lead sponsor
NGM Biopharmaceuticals, Inc
Responsible party
Sponsor
First posted
Mar 10, 2016
Start date
Mar 2016
Primary completion
Jun 2017
Completion
Jun 2017
Results posted
Jun 17, 2025
Last update
Jun 17, 2025

Study contacts

Stephen J Rossi, PharmD
study director · NGM Biopharmaceuticals, Inc

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Aldafermin

Other studies in this condition

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Other studies from this sponsor

NGM Biopharmaceuticals, Inc →

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