A Phase 2 interventional study of NGM282 and Placebo in NASH - Nonalcoholic Steatohepatitis, sponsored by NGM Biopharmaceuticals, Inc. Completed at 37 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-07-03.
Sponsored by NGM Biopharmaceuticals, Inc · Phase 2, Interventional, and Treatment
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.
Among the 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States, this one is the 95th largest by enrollment of the 460 interventional ones that give a count, is one of 62 that started in 2019, is one of 192 in phase 2, and was the 283rd registered.
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 →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:
Regeneron Pharmaceuticals · Sites in United States
Ages 18–75
Regeneron Pharmaceuticals · Sites in United States, Puerto Rico, United Kingdom
Ages 18–75
Columbia University · Sites in United States
Ages 18–65
Regeneron Pharmaceuticals · Sites in United States
Ages 18–75
GlaxoSmithKline · Sites in United States
Ages 18–70
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 →
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.
547 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 93 · Phase 2 213 · Phase 3 36 · Phase 4 13
First in 2000; this study’s year is marked. 62 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 171 is above the median of 60 across 1,177 interventional studies indexed under Non-alcoholic Fatty Liver Disease.
Median enrollment 56 across the 460 interventional studies, 90 across the 85 observational. Of the 420 that completed or were terminated, 215 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
246 of 547 have an industry lead sponsor. The 10 most frequent:
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.
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 |
Add all 22 to your calendar (.ics) → With an account.
Among the 547 studies in Non-alcoholic Fatty Liver Disease with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a multi-center evaluation of NGM282 in a randomized, double-blind, placebo-controlled study administered for 24 weeks in participants with histologically confirmed NASH and F2/F3 Fibrosis.
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.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria could apply.
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.
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
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.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Administered by subcutaneous injection
Biological: NGM282
Administered by subcutaneous injection
Biological: NGM282
Administered by subcutaneous injection
Biological: NGM282
Administered by subcutaneous injection
Other: Placebo
NGM282
Placebo for NGM282
Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Liver biopsies were collected at baseline and Week 24 and read by a central pathologist using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) criteria. Fibrosis stages of F0, F1, F2, F3 and F4 are defined by NASH CRN criteria with F0 (minimal score) indicating no fibrosis and F4 (maximal score) indicating liver cirrhosis. Liver fibrosis response was defined as an improvement in liver fibrosis \>=1 stage with no worsening of steatohepatitis on liver biopsy at Week 24 compared with baseline.
Time frame: Baseline up to Week 24
Number of Participants With Treatment-emergent Adverse Events After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that commenced on or after the date and time of first study drug administration.
Time frame: Baseline up to Week 24
Mean Percentage of Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Mean percentage of liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).
Time frame: Baseline, Week 12, Week 24, and Week 30
Change From Baseline in Liver Fat Content in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Change from baseline in liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). Negative values indicate an improvement in liver fat content.
Time frame: Baseline to Week 12, Week 24, and Week 30
Number of Participants With Liver Fat Normalization and Response in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis
Liver fat normalization (LFC; defined as \<5%) and response (LFC decrease \>=5% from baseline and LFC relative decrease \>=30% from baseline) were assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). The responders were defined as participants with either normalization (\<5%) or response (decrease from baseline \>=5% or relative decrease from baseline \>=30%).
Time frame: Baseline to Week 12, Week 24 and Week 30
A total of 171 participants who met all inclusion criteria and no exclusion criteria were randomized to receive treatment at 37 clinic sites in the United States.
| Milestone | Aldafermin 0.3 mg | Aldafermin 1.0 mg | Aldafermin 3.0 mg | Placebo |
|---|---|---|---|---|
| Started | 43 | 42 | 43 | 43 |
| Completed | 35 | 35 | 37 | 36 |
| Not completed | 8 | 7 | 6 | 7 |
| Withdrew: Adverse event | 3 | 3 | 2 | 2 |
| Withdrew: Lost to follow-up | 3 | 2 | 1 | 2 |
| Withdrew: Withdrawal by subject | 1 | 1 | 2 | 0 |
| Withdrew: Physician decision | 1 | 0 | 0 | 3 |
| Withdrew: Other | 0 | 1 | 1 | 0 |
Liver biopsies were collected at baseline and Week 24 and read by a central pathologist using Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) criteria. Fibrosis stages of F0, F1, F2, F3 and F4 are defined by NASH CRN criteria with F0 (minimal score) indicating no fibrosis and F4 (maximal score) indicating liver cirrhosis. Liver fibrosis response was defined as an improvement in liver fibrosis \>=1 stage with no worsening of steatohepatitis on liver biopsy at Week 24 compared with baseline.
| score on a scale | Aldafermin 0.3 mg | Aldafermin 1.0 mg | Aldafermin 3.0 mg | Placebo |
|---|---|---|---|---|
| Liver Fibrosis Response After Administration With Aldafermin in Participants With Nonalcoholic Steatohepatitis and Stage 2/3 Fibrosis | 0.24 ± 0.04 | 0.25 ± 0.04 | 0.27 ± 0.07 | 0.23 ± 0.06 |
Treatment-emergent adverse events (TEAEs) were defined as adverse events (AEs) that commenced on or after the date and time of first study drug administration.
| Participants | Aldafermin 0.3 mg | Aldafermin 1.0 mg | Aldafermin 3.0 mg | Placebo |
|---|---|---|---|---|
| Any TEAE | 30 | 34 | 38 | 36 |
| Any TEAE, Grade 1 | 11 | 12 | 17 | 10 |
| Any TEAE, Grade 2 | 16 | 18 | 19 | 24 |
| Any TEAE, Grade 3 | 1 | 2 | 2 | 1 |
| Any TEAE, Grade 4 | 2 | 1 | 0 | 1 |
| Any TEAE, Grade 5 | 0 | 1 | 0 | 0 |
| Any aldafermin-related TEAE | 13 | 20 | 21 | 14 |
| Any TEAE, not related to aldafermin | 17 | 14 | 17 | 22 |
| Any TEAE, possible related to aldafermin | 10 | 8 | 7 | 11 |
| Any TEAE, probable related to aldafermin | 2 | 5 | 5 | 2 |
| Any TEAE, definite related to aldafermin | 1 | 7 | 9 | 1 |
| Any rosuvastatin-related TEAE | 13 | 4 | 9 | 8 |
| Any TEAE, not related to rosuvastatin | 17 | 30 | 29 | 28 |
| Any TEAE, possible related to rosuvastatin | 10 | 1 | 6 | 6 |
| Any TEAE, probable related to rosuvastatin | 1 | 1 | 3 | 1 |
| Any TEAE, definite related to rosuvastatin | 2 | 2 | 0 | 1 |
| Any TEAE leading to study drug withdrawal | 3 | 4 | 3 | 3 |
| Any aldafermin-related TEAE leading to study drug withdrawal | 1 | 1 | 1 | 2 |
| Any rosuvastatin-related TEAE leading to study drug withdrawal | 2 | 0 | 0 | 1 |
| Any serious TEAE | 1 | 4 | 1 | 3 |
| Any TEAEs leading to death | 0 | 1 | 0 | 0 |
Mean percentage of liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF).
| percentage of liver fat content | Aldafermin 0.3 mg | Aldafermin 1.0 mg | Aldafermin 3.0 mg | Placebo |
|---|---|---|---|---|
| Baseline | 19.13 ± 7.6 | 17.40 ± 6.4 | 18.69 ± 7.5 | 17.00 ± 6.6 |
| Week 12 | 14.43 ± 8.8 | 10.62 ± 5.6 | 7.03 ± 5.7 | 16.00 ± 7.1 |
| Week 24 | 14.85 ± 9.3 | 10.64 ± 6.2 | 6.72 ± 5.6 | 14.01 ± 6.2 |
| Week 30 | 16.30 ± 9.2 | 15.36 ± 6.5 | 13.10 ± 7.4 | 14.27 ± 7.5 |
Change from baseline in liver fat content was assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). Negative values indicate an improvement in liver fat content.
| percentage of liver fat content | Aldafermin 0.3 mg | Aldafermin 1.0 mg | Aldafermin 3.0 mg | Placebo |
|---|---|---|---|---|
| Change from baseline to Week 12 | -4.28 ± 0.83 | -7.50 ± 0.85 | -11.37 ± 0.84 | -1.49 ± 0.82 |
| Change from baseline to Week 24 | -3.73 ± 0.97 | -7.35 ± 1.04 | -11.37 ± 0.98 | -3.44 ± 0.98 |
| Mean change from baseline to Week 30 | -2.10 ± 1.08 | -2.95 ± 1.13 | -5.19 ± 1.05 | -2.92 ± 1.05 |
Liver fat normalization (LFC; defined as \<5%) and response (LFC decrease \>=5% from baseline and LFC relative decrease \>=30% from baseline) were assessed by magnetic resonance imaging-proton density fat fraction (MRI-PDFF). The responders were defined as participants with either normalization (\<5%) or response (decrease from baseline \>=5% or relative decrease from baseline \>=30%).
| Participants | Aldafermin 0.3 mg | Aldafermin 1.0 mg | Aldafermin 3.0 mg | Placebo |
|---|---|---|---|---|
| Week 12: Normalization, response | 3 | 4 | 17 | 0 |
| Week 12: Normalization, No response | 35 | 33 | 20 | 39 |
| Week 12: Decrease >=5%, Response | 19 | 24 | 33 | 7 |
| Week 12: Decrease >=5%, No response | 19 | 13 | 4 | 32 |
| Week 12: Relative decrease >=30%, Response | 19 | 25 | 33 | 7 |
| Week 12: Relative decrease >=30%, No response | 19 | 12 | 4 | 32 |
| Week 24: Normalization, response | 4 | 4 | 20 | 2 |
| Week 24: Normalization, No response | 33 | 29 | 17 | 35 |
| Week 24: Decrease >=5%, Response | 21 | 21 | 30 | 10 |
| Week 24: Decrease >=5%, No response | 16 | 12 | 7 | 27 |
| Week 24: Relative decrease >=30%, Response | 18 | 20 | 32 | 11 |
| Week 24: Relative decrease >=30%, No response | 19 | 13 | 5 | 26 |
| Week 30: Normalization, response | 4 | 1 | 4 | 4 |
| Week 30: Normalization, No response | 30 | 30 | 32 | 32 |
| Week 30: Decrease >=5%, Response | 8 | 12 | 15 | 9 |
| Week 30: Decrease >=5%, No response | 26 | 19 | 21 | 27 |
| Week 30: Relative decrease >=30%, Response | 10 | 11 | 16 | 10 |
| Week 30: Relative decrease >=30%, No response | 24 | 20 | 20 | 26 |
Collected over Treatment-emergent adverse events (TEAEs) were collected from screening up to Week 30.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Aldafermin 0.3 mg | 0/43 (0%) | 1/43 (2.3%) | 30/43 (69.8%) |
| Aldafermin 1.0 mg | 1/41 (2.4%) | 4/41 (9.8%) | 34/41 (82.9%) |
| Aldafermin 3.0 mg | 0/43 (0%) | 1/43 (2.3%) | 38/43 (88.4%) |
| Placebo | 0/43 (0%) | 3/43 (7%) | 36/43 (83.7%) |
| Event | Aldafermin 0.3 mg | Aldafermin 1.0 mg | Aldafermin 3.0 mg | Placebo |
|---|---|---|---|---|
| Suicide attemptPsychiatric disorders | 0/43 | 1/41 | 0/43 | 0/43 |
| Cardiac hypertrophyCardiac disorders | 0/43 | 1/41 | 0/43 | 0/43 |
| ObesityMetabolism and nutrition disorders | 0/43 | 1/41 | 0/43 | 0/43 |
| Small intestinal obstructionGastrointestinal disorders | 0/43 | 1/41 | 0/43 | 0/43 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/43 | 1/41 | 0/43 | 0/43 |
| Uterine cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/43 | 0/41 | 0/43 | 0/43 |
| Cholecystitis chronicHepatobiliary disorders | 0/43 | 0/41 | 1/43 | 0/43 |
| Coronary artery diseaseCardiac disorders | 0/43 | 0/41 | 0/43 | 1/43 |
| Bronchogenic cystCongenital, familial and genetic disorders | 0/43 | 0/41 | 0/43 | 1/43 |
| Endometrial adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/43 | 0/41 | 0/43 | 1/43 |
| Event | Aldafermin 0.3 mg | Aldafermin 1.0 mg | Aldafermin 3.0 mg | Placebo |
|---|---|---|---|---|
| DiarrheaGastrointestinal disorders | 3/43 | 5/41 | 10/43 | 6/43 |
| NauseaGastrointestinal disorders | 5/43 | 8/41 | 7/43 | 8/43 |
| Injection site erythemaGeneral disorders | 0/43 | 4/41 | 6/43 | 0/43 |
| HeadacheNervous system disorders | 6/43 | 2/41 | 4/43 | 4/43 |
| SinusitisInfections and infestations | 0/43 | 5/41 | 1/43 | 1/43 |
| Abdominal pain upperGastrointestinal disorders | 5/43 | 3/41 | 2/43 | 4/43 |
| ConstipationGastrointestinal disorders | 5/43 | 1/41 | 1/43 | 2/43 |
| Abdominal distensionGastrointestinal disorders | 2/43 | 2/41 | 4/43 | 1/43 |
| Frequent bowel movementsGastrointestinal disorders | 1/43 | 1/41 | 4/43 | 0/43 |
| FatigueGeneral disorders | 3/43 | 0/41 | 4/43 | 4/43 |
Baseline characteristics were assessed in the Intent-to-Treat Analysis Set.
| Age, Categorical(Participants) | Aldafermin 0.3 mg | Aldafermin 1.0 mg | Aldafermin 3.0 mg | Placebo | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 1 | 0 | 0 | 1 |
| Between 18 and 65 years | 34 | 35 | 36 | 35 | 140 |
| >=65 years | 9 | 6 | 7 | 8 | 30 |
| Age, Continuous(years) | Aldafermin 0.3 mg | Aldafermin 1.0 mg | Aldafermin 3.0 mg | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 54.3 ± 11.2 | 49.8 ± 13.2 | 52.7 ± 11.1 | 53.0 ± 10.8 | 52.5 ± 11.6 |
| Sex: Female, Male(Participants) | Aldafermin 0.3 mg | Aldafermin 1.0 mg | Aldafermin 3.0 mg | Placebo | Total |
|---|---|---|---|---|---|
| Female | 28 | 29 | 29 | 26 | 112 |
| Male | 15 | 13 | 14 | 17 | 59 |
| Race/Ethnicity, Customized(Participants) | Aldafermin 0.3 mg | Aldafermin 1.0 mg | Aldafermin 3.0 mg | Placebo | Total |
|---|---|---|---|---|---|
| White | 40 | 38 | 39 | 41 | 158 |
| Black or African American | 0 | 2 | 0 | 2 | 4 |
| Asian | 0 | 0 | 1 | 0 | 1 |
| American Indian or Alaska Native | 1 | 0 | 2 | 0 | 3 |
| Native Hawaiian or other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Other | 2 | 2 | 1 | 0 | 5 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from May 2019 to primary completion in Mar 2021, 21 months.
Results were first posted in Jul 2025, 4 years 3 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 21 months is close to 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.
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
Non-alcoholic Fatty Liver Disease →