CompletedNCT02443116Updated Jul 23, 2025Results posted

Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

A Phase 2 interventional study of NGM282 and Placebo in Nonalcoholic Steatohepatitis (NASH), sponsored by NGM Biopharmaceuticals, Inc. Completed at 22 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-23.

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

Phase: Phase 2
Study type: Interventional
Enrollment: 254
Allocation: Randomized
Ages: 18 Years to 75 Years
Sex: All

Where this study stands

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

Among 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States — 60 open to participants now, 93 under way, 13 of them phase 3. Non-alcoholic Fatty Liver Disease · United States.

Enrollment: 52nd of 460; 254 · median 56
Started: 2015; with 31 others
Phase 2: 192 of 547; 15 open now
Registered: 147th of 547; by date

Among the 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States, this one is the 52nd largest by enrollment of the 460 interventional ones that give a count, is one of 32 that started in 2015, is one of 192 in phase 2, and was the 147th registered.

Non-alcoholic Fatty Liver Disease

1,618 studies on the registry are indexed under Non-alcoholic Fatty Liver Disease; 323 are open to participants now.

Browse Non-alcoholic Fatty Liver Disease studies →

Open to participants now

60 of the 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States are open now. Recruiting first, the newest first:

RecruitingPhase 3NCT07854782
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Regeneron Pharmaceuticals · Sites in United States
Ages 18–75
RecruitingPhase 2NCT07631637
Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)
Regeneron Pharmaceuticals · Sites in United States, Puerto Rico, United Kingdom
Ages 18–75
RecruitingPhase 1NCT07403604
Effect of Insulin Lowering on Lipogenesis
Columbia University · Sites in United States
Ages 18–65
RecruitingPhase 2NCT07527910
A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD
Regeneron Pharmaceuticals · Sites in United States
Ages 18–75
RecruitingPhase 1NCT07358546
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
GlaxoSmithKline · Sites in United States
Ages 18–70

55 more — sign in →

All 60 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 220 Non-alcoholic Fatty Liver Disease studies recruiting now, 66 (30%) set no upper age limit and 125 (57%) stop at 75 or younger; 27 take children under 18; 55 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.

Who runs the 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States

246 of 547 have an industry lead sponsor. The 10 most frequent:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)20 · 2 open

Gilead Sciences16 · industry

Massachusetts General Hospital15 · 1 open

University of California, San Diego13 · 1 open

Columbia University11 · 3 open

Pfizer11 · industry

Yale University9 · 3 open

Bristol-Myers Squibb8 · industry

Corcept Therapeutics8 · industry

GlaxoSmithKline8 · 4 open · industry

NGM Biopharmaceuticals, Inc in Non-alcoholic Fatty Liver Disease

NGM Biopharmaceuticals, Inc is the lead sponsor of 26 studies on the registry; 1 is open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 4 (44%) have results posted.

NGM Biopharmaceuticals, Inc has 4 studies filed under Non-alcoholic Fatty Liver Disease — fewer than ten, so there is no comparison to draw.

Browse NGM Biopharmaceuticals, Inc studies →Its Non-alcoholic Fatty Liver Disease studies →

Coming up

22 of the studies in Non-alcoholic Fatty Liver Disease with a site in United States that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:

Study	Primary completion
NCT04951219Phase 3Madrigal Pharmaceuticals, Inc.A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)	2027-03
NCT04833140Phase 3Massachusetts General HospitalEstrogen Administration for the Treatment of NASH in Postmenopausal Women	2027-07-09
NCT00983463Vanderbilt UniversityAbundance and Distribution of Lipids and Proteins in Nonalcoholic Fatty Liver Disease (NAFLD)	2026-11
NCT05165706Stanford UniversityLongitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance	2026-11-30
NCT05067621Yale UniversitySemaglutide Effects in Obese Youth With Prediabetes/New Onset Type 2 Diabetes and Metabolic Dysfunction-Associated Steatotic Liver Disease	2026-12

All 22 — sign in →

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What changed since 2026-09-25

Among the 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States, from their registry updates:

Newly registered 1

NCT078547822026-10-02Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)

Started recruiting 2

NCT078547822026-11-02Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
NCT076316372026-10-26Study to Evaluate ALN-CIDEB in Adults With Fibrotic Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Stopped 1

NCT035878312026-09-30TERMINATEDVertical Sleeve Gastrectomy and Lifestyle Modification for the Treatment of Non-Alcoholic Steatohepatitis

Results posted 4

NCT058099342026-10-28A Study to Evaluate AZD2693 in Participants Who Are Carriers of the PNPLA3 148M Risk Allele With Non-cirrhotic Non-alcoholic Steatohepatitis With Fibrosis
NCT061043192026-10-27Dose Exploration Study of GSK4532990 in. Participants With NASH or Suspected NASH
NCT055005862026-10-14The Effects of Glucagon on Hepatic Metabolism
NCT057292822026-09-30Glycemic Effect of Diazoxide in NAFLD

Primary completion moved 14

NCT069200432026-11-052028-07-10 → 2028-07-03A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
NCT068366092026-11-042027-05-15 → 2027-08-17A Study to Evaluate ALN-CIDEB in Adult Participants With Metabolic Dysfunction-Associated Steatotic Liver Disease or With Metabolic Dysfunction-Associated Steatohepatitis (MASLD/MASH)
NCT048497282026-11-022027-09-30 → 2026-09-29A Phase 3 Study Evaluating Efficacy and Safety of Lanifibranor Followed by an Active Treatment Extension in Adult Patients With (NASH) and Fibrosis Stages F2 and F3 ( NATiV3 )
NCT075187842026-11-022026-06-30 → 2026-08-07Accurate Point of Care Liver Disease Diagnostics (Phase 2)
NCT038840752026-10-272027-09-03 → 2028-08-31Non-Alcoholic Fatty Liver Disease, the HEpatic Response to Oral Glucose, and the Effect of Semaglutide (NAFLD HEROES)

9 more — sign in →

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

Watch this landscape Download CSV Narrow it in search →With an account: a weekly mail of what changed among 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States, or all of them as a file.

Study summary

The purpose of this study is to determine the safety, tolerability, and efficacy of NGM282 in patients with nonalcoholic steatohepatitis.

Conditions studied

Nonalcoholic Steatohepatitis (NASH)

Browse trials for

Non-alcoholic Fatty Liver Disease 1,618

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

Males or females, between 18 and 75 years of age, inclusive
confirmed NASH diagnosis

Exclusion criteria

Exclusion Criteria:

acute or chronic liver disease
Prior liver transplantation

Terms in these criteria, in plain language(2)

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.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

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.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Triple (Participant, Care provider, Investigator)
Enrollment: 254 participants (actual)

Study arms

Placebo comparator
Cohort 1 - Placebo
Cohort 1 - Placebo
Other: Placebo
Experimental
Cohort 1 - NGM282 3mg
Cohort 1 - NGM282 3mg
Biological: NGM282
Experimental
Cohort 1 - NGM282 6mg
Cohort 1 - NGM282 6mg
Biological: NGM282
Experimental
Cohort 2 - NGM282 0.3mg
Cohort 2 - NGM282 0.3mg
Biological: NGM282
Placebo comparator
Cohort 2 - NGM282 1mg
Cohort 2 - NGM282 1mg
Biological: NGM282
Experimental
Cohort 2 - NGM282 3mg
Cohort 2 - NGM282 3mg
Biological: NGM282
Experimental
Cohort 3 - NGM282 1mg
Cohort 3 - NGM282 1mg
Biological: NGM282
Placebo comparator
Cohort 4 - Placebo
Cohort 4 - Placebo
Other: Placebo
Experimental
Cohort 4 - NGM282 1mg
Cohort 4 - NGM282 1mg
Biological: NGM282

Interventions

BiologicalNGM282
OtherPlacebo

What researchers measure

Primary outcomes

Change in Absolute Liver Fat Content (Part 1)
Absolute liver fat content was assessed using magnetic resonance imaging (MRI).
Time frame: Up to Week 12
Change in Absolute Liver Fat Content (Part 2)
Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Time frame: Up to Week 12
Change in Absolute Liver Fat Content (Part 3)
Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Time frame: Up to Week 24

Secondary outcomes

Percentage Change in Liver Fat Content (Part 1)
Percentage change in liver fat content was assessed using magnetic resonance imaging (MRI).
Time frame: Up to Week 12
Change in Absolute Liver Fat Content (Part 2)
Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Time frame: Up to Week 18
Percentage Change in Liver Fat Content (Part 2)
Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Time frame: Up to Week 18
Change in Absolute Liver Fat Content (Part 3)
Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Time frame: Up to Week 30
Percentage Change in Liver Fat Content (Part 3)
Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).
Time frame: Up to Week 30

Results

Posted Jun 26, 2025

Participant flow

A total of 254 participants who met all inclusion criteria and no exclusion criteria were enrolled in this study. This was a 3-part study where Parts 1 and 3 were randomized, placebo controlled studies and Part 2 was an open-label study.

Part 1

Participant flow — Part 1
Milestone	Part 1: Aldafermin 3.0 mg	Part 1: Aldafermin 6.0 mg	Part 1: Placebo
Started	27	28	27
Completed	25	24	23
Not completed	2	4	4
Withdrew: Adverse event	2	3	0
Withdrew: Withdrew informed consent	0	1	0
Withdrew: Lost to follow-up	0	0	2
Withdrew: Participant moved out of state	0	0	1
Withdrew: Participant enrolled in another clinical trial	0	0	1

Part 2

Participant flow — Part 2
Milestone	Part 2: Aldafermin 0.3 mg	Part 2: Aldafermin 1.0 mg	Part 2: Aldafermin 3.0 mg	Part 2: Aldafermin 1.0 mg (Cohort 4)
Started	23	21	22	28
Completed	21	20	19	25
Not completed	2	1	3	3
Withdrew: Adverse event	0	1	1	2
Withdrew: Withdrew informed consent	0	0	1	1
Withdrew: Inability to comply with protocol	1	0	0	0
Withdrew: Lost to follow-up	1	0	0	0
Withdrew: Early end of treatment secondary to cardiac arrest and subsequently lost to follow up	0	0	1	0

Part 3

Participant flow — Part 3
Milestone	Part 3: Aldafermin 1.0 mg	Part 3: Placebo
Started	53	25
Completed	49	20
Not completed	4	5
Withdrew: Adverse event	0	1
Withdrew: Withdrew informed consent	3	2
Withdrew: Lost to follow-up	1	2

Outcome measures

PrimaryChange in Absolute Liver Fat Content (Part 1)

Absolute liver fat content was assessed using magnetic resonance imaging (MRI).

Time frame:: Up to Week 12
Reported as:: Least squares mean · percent of liver fat

Change in Absolute Liver Fat Content (Part 1)
percent of liver fat	Part 1: Aldafermin 3.0 mg	Part 1: Aldafermin 6.0 mg	Part 1: Placebo
Change in Absolute Liver Fat Content (Part 1)	-9.68 ± 0.98	-11.91 ± 1.00	-0.85 ± 0.99

Statistical analysis

Part 1: Aldafermin 3.0 mg vs Part 1: Placebo · t-test, 2 sided · p = <0.001 (p-values are adjusted using a stepdown-Bonferroni method to adjust for multiple testing.) · Difference in least squares means: -8.84 · 96% CI -12.09 to -5.59
Part 1: Aldafermin 6.0 mg vs Part 1: Placebo · t-test, 2 sided · p = <0.001 (p-values are adjusted using a stepdown-Bonferroni method to adjust for multiple testing.) · Difference in least squares means: -11.06 · 96% CI -14.39 to -7.74
Part 1: Aldafermin 3.0 mg vs Part 1: Aldafermin 6.0 mg · t-test, 2 sided · p = 0.112 · Difference in least squares means: -2.22 · 96% CI -5.11 to 0.67

PrimaryChange in Absolute Liver Fat Content (Part 2)

Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Time frame:: Up to Week 12
Reported as:: Least squares mean · percent of liver fat

Change in Absolute Liver Fat Content (Part 2)
percent of liver fat	Part 2: Aldafermin 0.3 mg	Part 2: Aldafermin 1.0 mg	Part 2: Aldafermin 3.0 mg	Part 2: Aldafermin 1.0 mg (Cohort 4)
Change in Absolute Liver Fat Content (Part 2)	-4.95 ± 1.07	-10.69 ± 1.09	-11.55 ± 1.08	-10.85 ± 1.01

Statistical analysis

Part 2: Aldafermin 0.3 mg vs Part 2: Aldafermin 1.0 mg · t-test, 2 sided · p = <0.0001 · Difference in least squares means: -5.73 · 95% CI -8.48 to -2.99
Part 2: Aldafermin 0.3 mg vs Part 2: Aldafermin 3.0 mg · t-test, 2 sided · p = <0.0001 · Difference in least squares means: -6.60 · 95% CI -9.41 to -3.79
Part 2: Aldafermin 1.0 mg vs Part 2: Aldafermin 3.0 mg · t-test, 2 sided · p = 0.5467 · Difference in least squares means: -0.87 · 95% CI -3.71 to 1.98
Part 2: Aldafermin 0.3 mg vs Part 2: Aldafermin 1.0 mg (Cohort 4) · t-test, 2 sided · p = <0.0001 · Difference in least squares means: -5.90 · 95% CI -8.55 to -3.25
Part 2: Aldafermin 1.0 mg vs Part 2: Aldafermin 1.0 mg (Cohort 4) · t-test, 2 sided · p = 0.9037 · Difference in least squares means: -0.17 · 95% CI -2.89 to 2.55
Part 2: Aldafermin 3.0 mg vs Part 2: Aldafermin 1.0 mg (Cohort 4) · t-test, 2 sided · p = 0.6134 · Difference in least squares means: 0.70 · 95% CI -2.05 to 3.45

PrimaryChange in Absolute Liver Fat Content (Part 3)

Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Time frame:: Up to Week 24
Reported as:: Least squares mean · percent of liver fat

Change in Absolute Liver Fat Content (Part 3)
percent of liver fat	Part 3: Aldafermin 1.0 mg	Part 3: Placebo
Change in Absolute Liver Fat Content (Part 3)	-7.70 ± 0.82	-2.73 ± 1.29

Statistical analysis

Part 3: Aldafermin 1.0 mg vs Part 3: Placebo · t-test, 2 sided · p = 0.0018 · Difference in least squares means: -4.97 · 95% CI -8.03 to -1.91

SecondaryPercentage Change in Liver Fat Content (Part 1)

Percentage change in liver fat content was assessed using magnetic resonance imaging (MRI).

Time frame:: Up to Week 12
Reported as:: Least squares mean · percentage change of liver fat content

Percentage Change in Liver Fat Content (Part 1)
percentage change of liver fat content	Part 1: Aldafermin 3.0 mg	Part 1: Aldafermin 6.0 mg	Part 1: Placebo
Percentage Change in Liver Fat Content (Part 1)	-47.98 ± 5.79	-60.09 ± 5.92	-2.57 ± 5.85

SecondaryChange in Absolute Liver Fat Content (Part 2)

Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Time frame:: Up to Week 18
Reported as:: Least squares mean · percent of liver fat

Change in Absolute Liver Fat Content (Part 2)
percent of liver fat	Part 2: Aldafermin 0.3 mg	Part 2: Aldafermin 1.0 mg	Part 2: Aldafermin 3.0 mg	Part 2: Aldafermin 1.0 mg (Cohort 4)
Week 6	-4.15 ± 0.93	-8.21 ± 0.97	-10.38 ± 0.94	-8.36 ± 0.87
Week 18	-4.51 ± 1.17	-3.87 ± 1.14	-7.67 ± 1.15	-5.72 ± 1.07

SecondaryPercentage Change in Liver Fat Content (Part 2)

Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Time frame:: Up to Week 18
Reported as:: Least squares mean · percentage change of liver fat content

Percentage Change in Liver Fat Content (Part 2)
percentage change of liver fat content	Part 2: Aldafermin 0.3 mg	Part 2: Aldafermin 1.0 mg	Part 2: Aldafermin 3.0 mg	Part 2: Aldafermin 1.0 mg (Cohort 4)
Week 6	-24.95 ± 4.94	-42.90 ± 5.19	-58.72 ± 5.01	-45.92 ± 4.63
Week 12	-29.09 ± 5.32	-55.10 ± 5.42	-63.84 ± 5.41	-57.85 ± 5.04
Week 18	-22.58 ± 6.66	-17.70 ± 6.44	-40.79 ± 6.55	-29.03 ± 6.07

SecondaryChange in Absolute Liver Fat Content (Part 3)

Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Time frame:: Up to Week 30
Reported as:: Least squares mean · percent of liver fat

Change in Absolute Liver Fat Content (Part 3)
percent of liver fat	Part 3: Aldafermin 1.0 mg	Part 3: Placebo
Week 6	-6.54 ± 0.59	-0.93 ± 0.89
Week 12	-8.43 ± 0.74	-1.89 ± 1.14
Week 30	-3.04 ± 0.77	-2.05 ± 1.19

SecondaryPercentage Change in Liver Fat Content (Part 3)

Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF).

Time frame:: Up to Week 30
Reported as:: Least squares mean · percentage change of liver fat content

Percentage Change in Liver Fat Content (Part 3)
percentage change of liver fat content	Part 3: Aldafermin 1.0 mg	Part 3: Placebo
Week 6	-36.59 ± 3.22	-2.17 ± 4.81
Week 12	-45.27 ± 4.26	-6.88 ± 6.60
Week 24	-38.76 ± 5.03	-13.10 ± 7.89
Week 30	-11.22 ± 4.91	-9.99 ± 7.59

Adverse events

Collected over Treatment-emergent adverse events were collected from Screening (Day -28 to Day -1) up to Week 30.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Part 1: Aldafermin 3.0 mg	0/27 (0%)	1/27 (3.7%)	26/27 (96.3%)
Part 1: Aldafermin 6.0 mg	0/28 (0%)	0/28 (0%)	27/28 (96.4%)
Part 1: Placebo	0/27 (0%)	0/27 (0%)	23/27 (85.2%)
Part 2: Aldafermin 0.3 mg	0/23 (0%)	0/23 (0%)	20/23 (87%)
Part 2: Aldafermin 1.0 mg	0/21 (0%)	1/21 (4.8%)	19/21 (90.5%)
Part 2: Aldafermin 3.0 mg	0/22 (0%)	4/22 (18.2%)	21/22 (95.5%)
Part 2: Aldafermin 1.0 mg (Cohort 4)	0/28 (0%)	1/28 (3.6%)	27/28 (96.4%)
Part 3: Aldafermin 1.0 mg	0/53 (0%)	2/53 (3.8%)	46/53 (86.8%)
Part 3: Placebo	0/25 (0%)	3/25 (12%)	22/25 (88%)

Most frequent serious events

Showing 10 of 15

Most frequent serious events
Event	Part 1: Aldafermin 3.0 mg	Part 1: Aldafermin 6.0 mg	Part 1: Placebo	Part 2: Aldafermin 0.3 mg	Part 2: Aldafermin 1.0 mg	Part 2: Aldafermin 3.0 mg	Part 2: Aldafermin 1.0 mg (Cohort 4)	Part 3: Aldafermin 1.0 mg	Part 3: Placebo
Vertigo positionalEar and labyrinth disorders	0/27	0/28	0/27	0/23	1/21	0/22	0/28	0/53	0/25
HeadacheNervous system disorders	0/27	0/28	0/27	0/23	1/21	0/22	0/28	0/53	0/25
Accelerated hypertensionVascular disorders	0/27	0/28	0/27	0/23	1/21	0/22	0/28	0/53	0/25
Cardiac arrestCardiac disorders	0/27	0/28	0/27	0/23	0/21	1/22	0/28	0/53	0/25
Chest painGeneral disorders	0/27	0/28	0/27	0/23	0/21	1/22	0/28	0/53	0/25
PneumoniaInfections and infestations	0/27	0/28	0/27	0/23	0/21	1/22	0/28	0/53	0/25
PleurisyRespiratory, thoracic and mediastinal disorders	0/27	0/28	0/27	0/23	0/21	1/22	0/28	0/53	0/25
AnxietyPsychiatric disorders	0/27	0/28	0/27	0/23	0/21	0/22	0/28	0/53	1/25
Mental status changesPsychiatric disorders	0/27	0/28	0/27	0/23	0/21	0/22	0/28	0/53	1/25
Suicidal ideationPsychiatric disorders	0/27	0/28	0/27	0/23	0/21	0/22	0/28	0/53	1/25

Most frequent other events

Showing 10 of 66

Most frequent other events
Event	Part 1: Aldafermin 3.0 mg	Part 1: Aldafermin 6.0 mg	Part 1: Placebo	Part 2: Aldafermin 0.3 mg	Part 2: Aldafermin 1.0 mg	Part 2: Aldafermin 3.0 mg	Part 2: Aldafermin 1.0 mg (Cohort 4)	Part 3: Aldafermin 1.0 mg	Part 3: Placebo
Low density lipoprotein increasedInvestigations	1/27	0/28	0/27	9/23	15/21	9/22	13/28	0/53	0/25
NauseaGastrointestinal disorders	8/27	3/28	1/27	2/23	6/21	6/22	12/28	5/53	6/25
Injection site erythemaGeneral disorders	6/27	11/28	2/27	0/23	2/21	0/22	1/28	0/53	0/25
HeadacheNervous system disorders	3/27	5/28	5/27	5/23	4/21	4/22	4/28	7/53	9/25
DiarrheaGastrointestinal disorders	2/27	3/28	4/27	0/23	3/21	2/22	8/28	15/53	6/25
DiarrhoeaGastrointestinal disorders	1/27	2/28	0/27	0/23	0/21	0/22	0/28	15/53	6/25
Loose stoolsGastrointestinal disorders	7/27	5/28	2/27	1/23	3/21	5/22	6/28	0/53	0/25
Blood cholesterol increasedInvestigations	0/27	0/28	0/27	0/23	2/21	4/22	7/28	0/53	0/25
VomitingGastrointestinal disorders	2/27	5/28	0/27	2/23	3/21	2/22	6/28	3/53	1/25
FatigueGeneral disorders	0/27	2/28	2/27	3/23	3/21	1/22	6/28	3/53	4/25

Baseline characteristics

Baseline characteristics were reported from the Safety Population.

Age, Categorical
Age, Categorical(Participants)	Part 1: Aldafermin 3.0 mg	Part 1: Aldafermin 6.0 mg	Part 1: Placebo	Part 2: Aldafermin 0.3 mg	Part 2: Aldafermin 1.0 mg	Part 2: Aldafermin 3.0 mg	Part 2: Aldafermin 1.0 mg (Cohort 4)	Part 3: Aldafermin 1.0 mg	Part 3: Placebo	Total
<=18 years	0	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	26	26	23	22	17	18	26	45	23	226
>=65 years	1	2	4	1	4	4	2	8	2	28

Age, Continuous
Age, Continuous(years)	Part 1: Aldafermin 3.0 mg	Part 1: Aldafermin 6.0 mg	Part 1: Placebo	Part 2: Aldafermin 0.3 mg	Part 2: Aldafermin 1.0 mg	Part 2: Aldafermin 3.0 mg	Part 2: Aldafermin 1.0 mg (Cohort 4)	Part 3: Aldafermin 1.0 mg	Part 3: Placebo	Total
Mean	52.0 ± 7.1	56.4 ± 7.8	52.8 ± 11.3	43.0 ± 11.7	51.5 ± 11.3	51.5 ± 11.7	49.8 ± 10.0	53.2 ± 12.1	54.1 ± 9.7	51.9 ± 10.8

Sex: Female, Male
Sex: Female, Male(Participants)	Part 1: Aldafermin 3.0 mg	Part 1: Aldafermin 6.0 mg	Part 1: Placebo	Part 2: Aldafermin 0.3 mg	Part 2: Aldafermin 1.0 mg	Part 2: Aldafermin 3.0 mg	Part 2: Aldafermin 1.0 mg (Cohort 4)	Part 3: Aldafermin 1.0 mg	Part 3: Placebo	Total
Female	16	16	20	13	18	18	20	26	16	163
Male	11	12	7	10	3	4	8	27	9	91

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Part 1: Aldafermin 3.0 mg	Part 1: Aldafermin 6.0 mg	Part 1: Placebo	Part 2: Aldafermin 0.3 mg	Part 2: Aldafermin 1.0 mg	Part 2: Aldafermin 3.0 mg	Part 2: Aldafermin 1.0 mg (Cohort 4)	Part 3: Aldafermin 1.0 mg	Part 3: Placebo	Total
Asian	1	1	0	0	0	0	1	3	0	6
Black	0	0	2	0	0	0	0	1	2	5
White	25	24	25	23	21	22	26	46	22	234
Pacific Islander	0	1	0	0	0	0	0	0	0	1
Other	1	2	0	0	0	0	1	3	1	8

Study locations

22 sites

NGM Clinical Study Site 922
Chandler, Arizona 85224, United States
NGM Clinical Study Site 923
Tucson, Arizona 85712, United States
NGM Clinical Study Site 924
Los Angeles, California 90057, United States
NGM Clinical Study Site 901
San Diego, California 92103, United States
NGM Clinical Study Site 902
Denver, Colorado, United States
NGM Clinical Study Site 917
Lakewood Rch, Florida 34211, United States
NGM Clinical Study Site 906
Chicago, Illinois 60611, United States
NGM Clinical Study Site 918
Kansas City, Missouri 64131, United States
NGM Clinical Study Site 903
Durham, North Carolina 27710, United States
NGM Clinical Study Site 921
Germantown, Tennessee 38138, United States
NGM Clinical Study Site 910
Dallas, Texas 75246, United States
NGM Clinical Study Site 920
Rollingwood, Texas 78746, United States
NGM Clinical Study Site 909
San Antonio, Texas 78229, United States
NGM Clinical Study Site 905
San Antonio, Texas 78234, United States
NGM Clinical Study Site 904
Charlottesville, Virginia 22908, United States
NGM Clinical Study Site 911
Richmond, Virginia 23226, United States
NGM Clinical Study Site 908
Seattle, Washington 98122, United States
NGM Clinical Study Site 703
Sydney, New South Wales 2050, Australia
NGM Clinical Study Site 704
Adelaide, South Australia 5042, Australia
NGM Clinical Study Site 701
Melbourne, Victoria 3004, Australia
NGM Clinical Study Site 705
Melbourne, Victoria 3065, Australia
NGM Clinical Study Site 916
San Juan, 00927, Puerto Rico

References and documents

Publications

Alkhouri N, Beyer C, Shumbayawonda E, Andersson A, Yale K, Rolph T, Chung RT, Vuppalanchi R, Cusi K, Loomba R, Pansini M, Dennis A. Decreases in cT1 and liver fat content reflect treatment-induced histological improvements in MASH. J Hepatol. 2025 Mar;82(3):438-445. doi: 10.1016/j.jhep.2024.08.031. Epub 2024 Sep 25. PubMed 39326675 ↗
Nedrud MA, Chaudhry M, Middleton MS, Moylan CA, Lerebours R, Luo S, Farjat A, Guy C, Loomba R, Abdelmalek MF, Sirlin CB, Bashir MR. MRI Quantification of Placebo Effect in Nonalcoholic Steatohepatitis Clinical Trials. Radiology. 2023 Mar;306(3):e220743. doi: 10.1148/radiol.220743. Epub 2022 Nov 1. PubMed 36318027 ↗
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 ↗
Loomba R, Ling L, Dinh DM, DePaoli AM, Lieu HD, Harrison SA, Sanyal AJ. The Commensal Microbe Veillonella as a Marker for Response to an FGF19 Analog in NASH. Hepatology. 2021 Jan;73(1):126-143. doi: 10.1002/hep.31523. Epub 2020 Dec 11. PubMed 32794259 ↗
Harrison SA, Neff G, Guy CD, Bashir MR, Paredes AH, Frias JP, Younes Z, Trotter JF, Gunn NT, Moussa SE, Kohli A, Nelson K, Gottwald M, Chang WCG, Yan AZ, DePaoli AM, Ling L, Lieu HD. Efficacy and Safety of Aldafermin, an Engineered FGF19 Analog, in a Randomized, Double-Blind, Placebo-Controlled Trial of Patients With Nonalcoholic Steatohepatitis. Gastroenterology. 2021 Jan;160(1):219-231.e1. doi: 10.1053/j.gastro.2020.08.004. Epub 2020 Aug 8. PubMed 32781086 ↗
Harrison SA, Rinella ME, Abdelmalek MF, Trotter JF, Paredes AH, Arnold HL, Kugelmas M, Bashir MR, Jaros MJ, Ling L, Rossi SJ, DePaoli AM, Loomba R. NGM282 for treatment of non-alcoholic steatohepatitis: a multicentre, randomised, double-blind, placebo-controlled, phase 2 trial. Lancet. 2018 Mar 24;391(10126):1174-1185. doi: 10.1016/S0140-6736(18)30474-4. Epub 2018 Mar 5. PubMed 29519502 ↗

Study documents

Study protocol ↗ · Mar 29, 2019
Statistical analysis plan ↗ · Oct 1, 2019

PDFs hosted by the registry, ClinicalTrials.gov.

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 Jul 2015 to primary completion in Dec 2019, 52 months.

Results were first posted in Jun 2025, 5 years 6 months after primary completion.

Of 132 industry-sponsored phase 2 interventional studies under Non-alcoholic Fatty Liver Disease, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 30. This study's 52 months is above that.

Counting every sponsor, half of 185 studies reached it within 26 months; a quarter within 16 and three quarters within 36.

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

Registered: May 11, 2015
First posted: May 13, 2015
StartActual: Jul 31, 2015
Primary completionActual: Dec 6, 2019
CompletionActual: Jan 17, 2020
Results first posted: Jun 26, 2025
Last update: Jul 23, 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 Jul 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02443116
Lead sponsor: NGM Biopharmaceuticals, Inc
Collaborators: NGM Biopharmaceuticals Australia Pty Ltd
Responsible party: Sponsor
First posted: May 13, 2015
Start date: Jul 31, 2015
Primary completion: Dec 6, 2019
Completion: Jan 17, 2020
Results posted: Jun 26, 2025
Last update: Jul 23, 2025

Study contacts

NGM Study Director

study director · NGM Biopharmaceuticals, Inc

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

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Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)

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