Trial · NCT02787304
Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH)
NCT02787304, Phase 2, Terminated, Mirum Pharmaceuticals, Inc.; results first posted 2019-11-25
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH). Trials, record NCT02787304. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02787304
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Volixibat (SHP626) in the Treatment of Adults With Nonalcoholic Steatohepatitis (NASH)
- NCT number
- NCT02787304
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 197 participants, actual
- Lead sponsor
- Mirum Pharmaceuticals, Inc.
- Conditions
- Non-Alcoholic Steatohepatitis
- Interventions
- SHP626, Placebo
- First posted
- 2016-06-01
- Last updated
- 2019-11-25
- Other registries' IDs
- eudract:2016-000203-82
- Results first posted
- 2019-11-25
- Limitations and caveats
At the Week 24 Interim Analysis, no differences were observed between any dose of Volixibat and placebo based on absolute change in steatosis from baseline, as assessed by MRI hepatic PDFF, and % change from baseline in ALT; the study was terminated.
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Achieving Binary Response on Liver Histology Between Volixibat (SHP626) and Placebo at Week 48 | Baseline, Week 48 | Binary response indicating (yes/no) whether a subject responded at week 48 with a reduction of at least 2 points, without worsening of fibrosis, from baseline nonalcoholic fatty liver disease (NAFLD) activity score (NAS). The NAS grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and ballooning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis(assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2). |
| Secondary | Change From Baseline to Week 48 on Liver Histology | Baseline, Week 48 | Change in liver histology will be measured by the individual NAS components (ballooning, inflammation, steatosis). The NAS grades NAFLD on liver biopsy based on the individual scoring of steatosis, inflammation and ballooning. The NAS is assessed on a scale of 0 to 8 with higher scores indicating more severe disease and lower scores indicating less severe disease. NAS is obtained by adding steatosis (assessed on a scale of 0 to 3), inflammation (assessed on a scale of 0 to 3) and ballooning (assessed on a scale of 0 to 2). |
| Secondary | Change From Baseline to Week 48 on Hepatic Steatosis | Baseline, Week 48 | Change in hepatic steatosis will be evaluated by measuring the reduction of liver fat with magnetic resonance imaging-proton density fat-fraction (MRI-PDFF) and stratified by treatment group. |
| Secondary | Change From Baseline to Week 48 on Liver Histology | Baseline, Week 48 | Change in liver histology will be measured by fibrosis stage. Fibrosis stage is assessed on a scale of 0-4 with higher scores indicating more severe disease and lower scores indicating less severe disease (F0 = no fibrosis, F4 = cirrhosis). |
| Secondary | Number of Participants With Resolution of NASH at Week 48 | Week 48 | Resolution of NASH is defined as total absence of ballooning \[score = 0\], absent or mild inflammation \[score 0-1\], steatosis can be present \[score 0-3\]) without worsening of fibrosis as assessed by liver histology at Week 48. |
| Secondary | Change From Baseline to Week 48 on Serum Liver-related Biochemistry | Baseline, Week 48 | Serum liver-related biochemistry will be analysed by measuring alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), and gamma glutamyl transferase (GGT). |
| Secondary | Change From Baseline to Week 48 on Serum Liver-related Biochemistry | Baseline, Week 48 | Serum liver-related biochemistry will be analysed by measuring total bilirubin (TB). |
| Secondary | Change From Baseline to Week 48 on Metabolic Indicators | Baseline, Week 48 | Metabolic indicators will be assessed by measuring fasting serum glucose levels and insulin levels. |
| Secondary | Change From Baseline to Week 48 on Metabolic Indicators | Baseline, Week 48 | Metabolic indicators will be assessed by measuring hemoglobin A1c (HbA1c). |
| Secondary | Change From Baseline to Week 48 on Serum Lipids | Baseline, Week 48 | Serum lipids level will be measured by calculating fasting total cholesterol, high-density lipoprotein-cholesterol (HDL-C), low-density lipoprotein-cholesterol (LDL-C), and triglycerides. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Achieving Binary Response on Liver Histology Between Volixibat (SHP626) and Placebo at Week 48 | Baseline, Week 48 | Full Analysis Set for subjects with liver biopsy at both Baseline and Week 48 (post hoc analysis) at the time of the interim analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 48 on Liver Histology | Baseline, Week 48 | Safety Analysis Set for subjects with liver biopsy at both Baseline and Week 48 (post hoc analysis) at the time of the interim analysis | score on a scale | MEAN |
| SECONDARY | Change From Baseline to Week 48 on Hepatic Steatosis | Baseline, Week 48 | Safety Analysis Set (post hoc analysis) - for subjects with Week 48 data at the time of interim analysis | absolute percentage | MEAN |
| SECONDARY | Change From Baseline to Week 48 on Liver Histology | Baseline, Week 48 | Full Analysis Set for subjects with liver biopsy at both Baseline and Week 48 (post hoc analysis) at the time of the interim analysis | units on a scale | MEAN |
| SECONDARY | Number of Participants With Resolution of NASH at Week 48 | Week 48 | Safety Analysis Set for subjects with liver biopsy at both Baseline and Week 48 (post hoc analysis) at the time of the interim analysis | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Change From Baseline to Week 48 on Serum Liver-related Biochemistry | Baseline, Week 48 | Safety Analysis Set (post hoc analysis) - for subjects with Week 48 data at the time of interim analysis | U/L | MEAN |
| SECONDARY | Change From Baseline to Week 48 on Serum Liver-related Biochemistry | Baseline, Week 48 | Safety Analysis Set (post hoc analysis) - for subjects with Week 48 data at the time of interim analysis | mg/dL | MEAN |
| SECONDARY | Change From Baseline to Week 48 on Metabolic Indicators | Baseline, Week 48 | Safety Analysis Set (post hoc analysis) - for subjects with Week 48 data at the time of interim analysis. For insulin levels, samples were collected but due to study termination for futility after the interim analysis, an analysis of this outcome measure was not performed. | mg/dL | MEAN |
| SECONDARY | Change From Baseline to Week 48 on Metabolic Indicators | Baseline, Week 48 | Safety Analysis Set (post hoc analysis) - for subjects with Week 48 data at the time of interim analysis. | percentage of glycated hemoglobin | MEAN |
| SECONDARY | Change From Baseline to Week 48 on Serum Lipids | Baseline, Week 48 | Safety Analysis Set (post hoc analysis) - for subjects with Week 48 data at the time of interim analysis | mg/dL | MEAN |
Source ClinicalTrials.gov
Results by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Achieving Binary Response on Liver Histology Between Volixibat (SHP626) and Placebo at Week 48 | SHP626 5 Milligram (mg) | 4 | Participants | ||
| Number of Subjects Achieving Binary Response on Liver Histology Between Volixibat (SHP626) and Placebo at Week 48 | SHP626 10 Milligram (mg) | 2 | Participants | ||
| Number of Subjects Achieving Binary Response on Liver Histology Between Volixibat (SHP626) and Placebo at Week 48 | SHP626 20 Milligram (mg) | 3 | Participants | ||
| Number of Subjects Achieving Binary Response on Liver Histology Between Volixibat (SHP626) and Placebo at Week 48 | Placebo (PBO) | 5 | Participants | ||
| Change From Baseline to Week 48 on Liver Histology | SHP626 5 Milligram (mg) | NAS - steatosis | -0.5 | Standard Deviation 0.82 | score on a scale |
| Change From Baseline to Week 48 on Liver Histology | SHP626 10 Milligram (mg) | NAS - steatosis | -0.2 | Standard Deviation 0.87 | score on a scale |
| Change From Baseline to Week 48 on Liver Histology | SHP626 20 Milligram (mg) | NAS - steatosis | -0.5 | Standard Deviation 0.93 | score on a scale |
| Change From Baseline to Week 48 on Liver Histology | Placebo (PBO) | NAS - steatosis | -0.3 | Standard Deviation 0.85 | score on a scale |
| Change From Baseline to Week 48 on Liver Histology | SHP626 5 Milligram (mg) | NAS - ballooning | -0.3 | Standard Deviation 0.9 | score on a scale |
| Change From Baseline to Week 48 on Liver Histology | SHP626 10 Milligram (mg) | NAS - ballooning | -0.2 | Standard Deviation 0.75 | score on a scale |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SHP626 5 Milligram (mg) | 49 | |
| Overall Study | STARTED | SHP626 10 Milligram (mg) | 50 | |
| Overall Study | STARTED | SHP626 20 Milligram (mg) | 49 | |
| Overall Study | STARTED | Placebo (PBO) | 49 | |
| Overall Study | COMPLETED | SHP626 5 Milligram (mg) | 13 | |
| Overall Study | COMPLETED | SHP626 10 Milligram (mg) | 12 | |
| Overall Study | COMPLETED | SHP626 20 Milligram (mg) | 8 | |
| Overall Study | COMPLETED | Placebo (PBO) | 15 | |
| Overall Study | NOT COMPLETED | SHP626 5 Milligram (mg) | 36 | |
| Overall Study | NOT COMPLETED | SHP626 10 Milligram (mg) | 38 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events140
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 | SHP626 5 Milligram (mg) | 38 | 49 | 43 |
| other | Diarrhoea | Gastrointestinal disorders | SHP626 10 Milligram (mg) | 35 | 49 | 46 |
| other | Diarrhoea | Gastrointestinal disorders | SHP626 20 Milligram (mg) | 35 | 49 | 47 |
| other | Diarrhoea | Gastrointestinal disorders | Placebo (PBO) | 10 | 49 | 11 |
| other | Abdominal pain | Gastrointestinal disorders | SHP626 5 Milligram (mg) | 10 | 49 | 11 |
| other | Abdominal pain | Gastrointestinal disorders | SHP626 10 Milligram (mg) | 9 | 49 | 10 |
| other | Abdominal pain | Gastrointestinal disorders | SHP626 20 Milligram (mg) | 6 | 49 | 6 |
| other | Abdominal pain | Gastrointestinal disorders | Placebo (PBO) | 3 | 49 | 3 |
| other | Nausea | Gastrointestinal disorders | SHP626 5 Milligram (mg) | 5 | 49 | 6 |
| other | Nausea | Gastrointestinal disorders | SHP626 10 Milligram (mg) | 4 | 49 | 6 |
1 to 10 of 140Source ClinicalTrials.gov
See all 140 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SHP626 5 Milligram (mg) | 0 | 49 |
| Total, all-cause mortality | SHP626 10 Milligram (mg) | 0 | 49 |
| Total, all-cause mortality | SHP626 20 Milligram (mg) | 0 | 49 |
| Total, all-cause mortality | Placebo (PBO) | 0 | 49 |
| Total, other adverse events | SHP626 5 Milligram (mg) | 44 | 49 |
| Total, other adverse events | SHP626 10 Milligram (mg) | 44 | 49 |
| Total, other adverse events | SHP626 20 Milligram (mg) | 42 | 49 |
| Total, other adverse events | Placebo (PBO) | 37 | 49 |
| Total, serious adverse events | SHP626 5 Milligram (mg) | 1 | 49 |
| Total, serious adverse events | SHP626 10 Milligram (mg) | 2 | 49 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32234329 | DERIVED |
Source PubMed
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/NCT02787304
GET https://conductscience.org/api/trials/v1/NCT02787304/results?page=2