Trial · NCT02443116
Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
NCT02443116, Phase 2, Completed, NGM Biopharmaceuticals, Inc; results first posted 2025-06-26
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH). Trials, record NCT02443116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02443116
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of NGM282 in Patients With Nonalcoholic Steatohepatitis (NASH)
- NCT number
- NCT02443116
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 254 participants, actual
- Lead sponsor
- NGM Biopharmaceuticals, Inc
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Interventions
- NGM282, Placebo
- First posted
- 2015-05-13
- Last updated
- 2025-07-23
- Results first posted
- 2025-06-26
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Absolute Liver Fat Content (Part 1) | Up to Week 12 | Absolute liver fat content was assessed using magnetic resonance imaging (MRI). |
| Primary | Change in Absolute Liver Fat Content (Part 2) | Up to Week 12 | Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF). |
| Primary | Change in Absolute Liver Fat Content (Part 3) | Up to Week 24 | Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF). |
| Secondary | Percentage Change in Liver Fat Content (Part 1) | Up to Week 12 | Percentage change in liver fat content was assessed using magnetic resonance imaging (MRI). |
| Secondary | Change in Absolute Liver Fat Content (Part 2) | Up to Week 18 | Absolute liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF). |
| Secondary | Percentage Change in Liver Fat Content (Part 2) | Up to Week 18 | Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF). |
| Secondary | Change in Absolute Liver Fat Content (Part 3) | Up to Week 30 | Absolute liver fat content was measured by magnetic resonance imaging proton density fat fraction (MRI-PDFF). |
| Secondary | Percentage Change in Liver Fat Content (Part 3) | Up to Week 30 | Percentage change in liver fat content was assessed using magnetic resonance imaging proton density fat fraction (MRI-PDFF). |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Absolute Liver Fat Content (Part 1) | Up to Week 12 | Absolute liver fat content was assessed in participants with available data in the Efficacy Population. | percent of liver fat | LEAST_SQUARES_MEAN |
| PRIMARY | Change in Absolute Liver Fat Content (Part 2) | Up to Week 12 | Absolute liver fat content was assessed in participants with available data in the Efficacy Population. | percent of liver fat | LEAST_SQUARES_MEAN |
| PRIMARY | Change in Absolute Liver Fat Content (Part 3) | Up to Week 24 | Absolute liver fat content was assessed in participants with available data in the Efficacy Population. | percent of liver fat | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change in Liver Fat Content (Part 1) | Up to Week 12 | Percentage change in liver fat content was assessed in the Efficacy Population. | percentage change of liver fat content | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Absolute Liver Fat Content (Part 2) | Up to Week 18 | Absolute liver fat content was assessed in participants with available data in the Efficacy Population. | percent of liver fat | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change in Liver Fat Content (Part 2) | Up to Week 18 | Percentage change in liver fat content was assessed in participants with available data in the Efficacy Population. | percentage change of liver fat content | LEAST_SQUARES_MEAN |
| SECONDARY | Change in Absolute Liver Fat Content (Part 3) | Up to Week 30 | Absolute liver fat content was assessed in the Efficacy Population in participants with available data. | percent of liver fat | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Change in Liver Fat Content (Part 3) | Up to Week 30 | Percentage change in liver fat content was assessed in participants with available data in the Efficacy Population. | percentage change of liver fat content | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group46
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Absolute Liver Fat Content (Part 1) | Part 1: Aldafermin 3.0 mg | -9.68 | Standard Error 0.98 | percent of liver fat | |
| Change in Absolute Liver Fat Content (Part 1) | Part 1: Aldafermin 6.0 mg | -11.91 | Standard Error 1.00 | percent of liver fat | |
| Change in Absolute Liver Fat Content (Part 1) | Part 1: Placebo | -0.85 | Standard Error 0.99 | percent of liver fat | |
| Change in Absolute Liver Fat Content (Part 2) | Part 2: Aldafermin 0.3 mg | -4.95 | Standard Error 1.07 | percent of liver fat | |
| Change in Absolute Liver Fat Content (Part 2) | Part 2: Aldafermin 1.0 mg | -10.69 | Standard Error 1.09 | percent of liver fat | |
| Change in Absolute Liver Fat Content (Part 2) | Part 2: Aldafermin 3.0 mg | -11.55 | Standard Error 1.08 | percent of liver fat | |
| Change in Absolute Liver Fat Content (Part 2) | Part 2: Aldafermin 1.0 mg (Cohort 4) | -10.85 | Standard Error 1.01 | percent of liver fat | |
| Change in Absolute Liver Fat Content (Part 3) | Part 3: Aldafermin 1.0 mg | -7.70 | Standard Error 0.82 | percent of liver fat | |
| Change in Absolute Liver Fat Content (Part 3) | Part 3: Placebo | -2.73 | Standard Error 1.29 | percent of liver fat | |
| Percentage Change in Liver Fat Content (Part 1) | Part 1: Aldafermin 3.0 mg | -47.98 | Standard Error 5.79 | percentage change of liver fat content |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 results by groupParticipant flow81
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1 | STARTED | Part 1: Aldafermin 3.0 mg | 27 | |
| Part 1 | STARTED | Part 1: Aldafermin 6.0 mg | 28 | |
| Part 1 | STARTED | Part 1: Placebo | 27 | |
| Part 1 | STARTED | Part 2: Aldafermin 0.3 mg | 0 | |
| Part 1 | STARTED | Part 2: Aldafermin 1.0 mg | 0 | |
| Part 1 | STARTED | Part 2: Aldafermin 3.0 mg | 0 | |
| Part 1 | STARTED | Part 2: Aldafermin 1.0 mg (Cohort 4) | 0 | |
| Part 1 | STARTED | Part 3: Aldafermin 1.0 mg | 0 | |
| Part 1 | STARTED | Part 3: Placebo | 0 | |
| Part 1 | COMPLETED | Part 1: Aldafermin 3.0 mg | 25 |
1 to 10 of 81Source ClinicalTrials.gov
See all 81 participant flowAdverse events729
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Loose stools | Gastrointestinal disorders | Part 1: Aldafermin 3.0 mg | 7 | 27 | |
| other | Loose stools | Gastrointestinal disorders | Part 1: Aldafermin 6.0 mg | 5 | 28 | |
| other | Loose stools | Gastrointestinal disorders | Part 1: Placebo | 2 | 27 | |
| other | Loose stools | Gastrointestinal disorders | Part 2: Aldafermin 0.3 mg | 1 | 23 | |
| other | Loose stools | Gastrointestinal disorders | Part 2: Aldafermin 1.0 mg | 3 | 21 | |
| other | Loose stools | Gastrointestinal disorders | Part 2: Aldafermin 3.0 mg | 5 | 22 | |
| other | Loose stools | Gastrointestinal disorders | Part 2: Aldafermin 1.0 mg (Cohort 4) | 6 | 28 | |
| other | Loose stools | Gastrointestinal disorders | Part 3: Aldafermin 1.0 mg | 0 | 53 | |
| other | Loose stools | Gastrointestinal disorders | Part 3: Placebo | 0 | 25 | |
| other | Nausea | Gastrointestinal disorders | Part 1: Aldafermin 3.0 mg | 8 | 27 |
1 to 10 of 729Source ClinicalTrials.gov
See all 729 adverse eventsAdverse event totals27
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Aldafermin 3.0 mg | 0 | 27 |
| Total, all-cause mortality | Part 1: Aldafermin 6.0 mg | 0 | 28 |
| Total, all-cause mortality | Part 1: Placebo | 0 | 27 |
| Total, all-cause mortality | Part 2: Aldafermin 0.3 mg | 0 | 23 |
| Total, all-cause mortality | Part 2: Aldafermin 1.0 mg | 0 | 21 |
| Total, all-cause mortality | Part 2: Aldafermin 3.0 mg | 0 | 22 |
| Total, all-cause mortality | Part 2: Aldafermin 1.0 mg (Cohort 4) | 0 | 28 |
| Total, all-cause mortality | Part 3: Aldafermin 1.0 mg | 0 | 53 |
| Total, all-cause mortality | Part 3: Placebo | 0 | 25 |
| Total, other adverse events | Part 1: Aldafermin 3.0 mg | 26 | 27 |
1 to 10 of 27Source ClinicalTrials.gov
See all 27 adverse event totalsPapers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02443116
GET https://conductscience.org/api/trials/v1/NCT02443116/results?page=2