Trial · NCT02912260
Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)
NCT02912260, Phase 2, Completed, Madrigal Pharmaceuticals, Inc.; results first posted 2025-12-23
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH). Trials, record NCT02912260. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02912260
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Phase 2 Study of MGL-3196 in Patients With Non-Alcoholic Steatohepatitis (NASH)
- NCT number
- NCT02912260
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 125 participants, actual
- Lead sponsor
- Madrigal Pharmaceuticals, Inc.
- Conditions
- Non-alcoholic Steatohepatitis
- Interventions
- MGL-3196, Placebo
- First posted
- 2016-09-23
- Last updated
- 2025-12-23
- Results first posted
- 2025-12-23
Source ClinicalTrials.gov
Registered outcomes42
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percent Change From Baseline To Week 12 In Hepatic Fat Fraction Assessed By Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) | Week 12 | The primary endpoint was relative change in MRI-PDFF assessed hepatic fat fraction compared with placebo at Week 12 in participants who had both a baseline and Week 12 MRI-PDFF. Least squares (LS) mean was provided for the statistical comparison of MGL-3196 versus placebo. |
| Secondary | Percentage Of Participants With Adverse Events (AEs) | Week 12 and Week 36 | An AE was defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with the treatment. A summary of serious and all other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module. |
| Secondary | Percent Change From Baseline To Week 36 In Hepatic Fat Fraction Assessed By MRI-PDFF | Week 36 | The endpoint was relative change assessed hepatic fat fraction compared with placebo at Week 36. LS mean was provided for the statistical comparison of MGL-3196 versus placebo. |
| Secondary | Change From Baseline To Week 12 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF | Week 12 | The endpoint was change in MRI-PDFF assessed absolute hepatic fat fraction compared with placebo at Week 12. LS mean was provided for the comparison of MGL-3196 versus placebo. |
| Secondary | Change From Baseline To Week 36 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF | Week 36 | The endpoint was change in assessed absolute hepatic fat fraction compared with placebo at Week 36. LS mean was provided for the comparison of MGL-3196 versus placebo. |
| Secondary | Percentage Of Participants With At Least 30% Relative Fat Reduction at Week 12 | Week 12 | The endpoint presented the percentage of participants achieving a relative fat reduction of ≥30% at Week 12. |
| Secondary | Percentage Of Participants With At Least 30% Relative Fat Reduction At Week 36 | Week 36 | The endpoint presented the percentage of participants achieving a relative fat reduction of ≥30% at Week 36. |
| Secondary | Percentage Of Participants Achieving A 1-Point Reduction In Non-alcoholic Fatty Liver Disease Activity Score (NAS) At Week 36 | Week 36 | The NAS is a histologic scale for non-alcoholic steatohepatitis (NASH) activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 1-point or greater reduction in NAS. |
| Secondary | Percentage Of Participants Achieving A 2-Point Reduction In NAS At Week 36 | Week 36 | The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 2-point or greater reduction in NAS. |
| Secondary | Percentage Of Participants Achieving A 2-Point Reduction In NAS And Either A ≥1-Point Reduction In Lobular Inflammation Or Hepatocellular Ballooning At Week 36 | Week 36 | The NAS is a histologic scale for NASH activity, which combines into a single score steatosis (Grade 0 to 3), ballooning (Grade 0 to 2), and lobular inflammation (Grade 0 to 3). The endpoint presented the percentage of participants with a 2-point or greater reduction in NAS and a 1-point or greater reduction in lobular inflammation or hepatocellular ballooning. |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 registered outcomesOutcomes42
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percent Change From Baseline To Week 12 In Hepatic Fat Fraction Assessed By Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) | Week 12 | MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Of Participants With Adverse Events (AEs) | Week 12 and Week 36 | Safety population: all randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percent Change From Baseline To Week 36 In Hepatic Fat Fraction Assessed By MRI-PDFF | Week 36 | Modified Intent-to-Treat (mITT) population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percent change | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To Week 12 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF | Week 12 | MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit. | percentage | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline To Week 36 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage Of Participants With At Least 30% Relative Fat Reduction at Week 12 | Week 12 | MRI-PDFF evaluable population: all participants who were randomized in the study, received study drug, and finished Week 12 visit, with valid MRI-PDFF measurements at both baseline and Week 12 Visit. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants With At Least 30% Relative Fat Reduction At Week 36 | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants Achieving A 1-Point Reduction In Non-alcoholic Fatty Liver Disease Activity Score (NAS) At Week 36 | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants Achieving A 2-Point Reduction In NAS At Week 36 | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage of participants | NUMBER |
| SECONDARY | Percentage Of Participants Achieving A 2-Point Reduction In NAS And Either A ≥1-Point Reduction In Lobular Inflammation Or Hepatocellular Ballooning At Week 36 | Week 36 | mITT population: all participants who were randomized in the study, received at least 1 dose of study drug, and had lipid and other efficacy measurements at Week 4 or later visits. | percentage of participants | NUMBER |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 outcomesResults by group120
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percent Change From Baseline To Week 12 In Hepatic Fat Fraction Assessed By Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) | MGL-3196 | -32.9 | Standard Error 3.0 | percent change | |
| Percent Change From Baseline To Week 12 In Hepatic Fat Fraction Assessed By Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) | Placebo | -10.4 | Standard Error 4.3 | percent change | |
| Percentage Of Participants With Adverse Events (AEs) | MGL-3196 | Week 12 | 71.4 | percentage of participants | |
| Percentage Of Participants With Adverse Events (AEs) | Placebo | Week 12 | 46.3 | percentage of participants | |
| Percentage Of Participants With Adverse Events (AEs) | MGL-3196 | Week 36 | 86.9 | percentage of participants | |
| Percentage Of Participants With Adverse Events (AEs) | Placebo | Week 36 | 68.3 | percentage of participants | |
| Percent Change From Baseline To Week 36 In Hepatic Fat Fraction Assessed By MRI-PDFF | MGL-3196 | -37.3 | Standard Error 3.7 | percent change | |
| Percent Change From Baseline To Week 36 In Hepatic Fat Fraction Assessed By MRI-PDFF | Placebo | -8.9 | Standard Error 5.4 | percent change | |
| Change From Baseline To Week 12 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF | MGL-3196 | -7.0 | Standard Error 0.6 | percentage | |
| Change From Baseline To Week 12 In Absolute Hepatic Fat Fraction Assessed By MRI-PDFF | Placebo | -2.7 | Standard Error 0.8 | percentage |
1 to 10 of 120Source ClinicalTrials.gov
See all 120 results by groupParticipant flow14
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Main Study | STARTED | MGL-3196 | 84 | |
| Main Study | STARTED | Placebo | 41 | |
| Main Study | Received at Least 1 Dose of Study Drug | MGL-3196 | 84 | |
| Main Study | Received at Least 1 Dose of Study Drug | Placebo | 41 | |
| Main Study | COMPLETED | MGL-3196 | 74 | |
| Main Study | COMPLETED | Placebo | 34 | |
| Main Study | NOT COMPLETED | MGL-3196 | 10 | |
| Main Study | NOT COMPLETED | Placebo | 7 | |
| Extension Study | STARTED | MGL-3196 | 17 | |
| Extension Study | STARTED | Placebo | 14 |
1 to 10 of 14Source ClinicalTrials.gov
See all 14 participant flowAdverse events69
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 | Diarrhoea | Gastrointestinal disorders | MGL-3196 Main Study | 31 | 84 | 49 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo Main Study | 4 | 41 | 4 |
| other | Diarrhoea | Gastrointestinal disorders | Extension Study | 2 | 31 | 6 |
| other | Nausea | Gastrointestinal disorders | MGL-3196 Main Study | 17 | 84 | 17 |
| other | Nausea | Gastrointestinal disorders | Placebo Main Study | 2 | 41 | 2 |
| other | Nausea | Gastrointestinal disorders | Extension Study | 0 | 31 | 0 |
| other | Abdominal Pain | Gastrointestinal disorders | MGL-3196 Main Study | 6 | 84 | 8 |
| other | Abdominal Pain | Gastrointestinal disorders | Placebo Main Study | 3 | 41 | 3 |
| other | Abdominal Pain | Gastrointestinal disorders | Extension Study | 0 | 31 | 0 |
| other | Abdominal Pain Upper | Gastrointestinal disorders | MGL-3196 Main Study | 7 | 84 | 9 |
1 to 10 of 69Source ClinicalTrials.gov
See all 69 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | MGL-3196 Main Study | 0 | 84 |
| Total, all-cause mortality | Placebo Main Study | 0 | 41 |
| Total, all-cause mortality | Extension Study | 0 | 31 |
| Total, other adverse events | MGL-3196 Main Study | 73 | 84 |
| Total, other adverse events | Placebo Main Study | 28 | 41 |
| Total, other adverse events | Extension Study | 6 | 31 |
| Total, serious adverse events | MGL-3196 Main Study | 5 | 84 |
| Total, serious adverse events | Placebo Main Study | 2 | 41 |
| Total, serious adverse events | Extension Study | 0 | 31 |
Source ClinicalTrials.gov
Papers4
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/NCT02912260
GET https://conductscience.org/api/trials/v1/NCT02912260/registered?page=2