Trial · NCT03053050
Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
NCT03053050, Phase 3, Terminated, Gilead Sciences; results first posted 2020-06-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis. Trials, record NCT03053050. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03053050
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of Selonsertib in Adults With Nonalcoholic Steatohepatitis (NASH) and Bridging (F3) Fibrosis
- NCT number
- NCT03053050
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 808 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Nonalcoholic Steatohepatitis
- Interventions
- SEL, Placebo to match SEL 6 mg, Placebo to match SEL 18 mg
- First posted
- 2017-02-14
- Last updated
- 2020-06-29
- Other registries' IDs
- eudract:2016-004374-18
- Results first posted
- 2020-06-29
- Limitations and caveats
- Based on the results of the Week 48 analysis, the study was terminated early for lack of efficacy as prespecified in the clinical study protocol.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48 | Week 48 | Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the Non-Alcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS) criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. |
| Primary | Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event | Week 240 | EFS was assessed by the time to the first clinical event, including progression to cirrhosis on liver biopsy, liver decompensation events, liver transplantation, and all-cause mortality. |
| Secondary | Percentage of Participants Who Had Progression to Cirrhosis at Week 48 | Week 48 | Progression to cirrhosis was defined as a change in NASH CRN fibrosis stage from \< 4 at baseline to 4 at Week 48. |
| Secondary | Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240 | Week 240 | Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). Worsening of NASH was defined as ≥ 1 point increase from baseline in hepatocellular ballooning or lobular inflammation according to the NAS criteria. As defined by NAS, hepatocellular ballooning ranges from 0-2 and lobular inflammation ranges from 0-3, with higher scores indicating more severe hepatocellular ballooning or lobular inflammation. |
| Secondary | Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48 | Week 48 | Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). |
| Secondary | Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 240 | Week 240 | Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. NASH CRN fibrosis stages range from 0 to 4, with higher scores indicating greater fibrosis (0=None, 4=Cirrhosis). |
| Secondary | Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 48 | Week 48 | NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN. |
| Secondary | Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 240 | Week 240 | NASH resolution was defined as lobular inflammation of 0 or 1 from ≥ 1 at baseline and hepatocellular ballooning of 1 from a value ≥ 1 at baseline; both criteria were necessary conditions. Evaluable participants had baseline lobular inflammation and hepatocellular ballooning ≥ 1. Worsening of Fibrosis was defined by an increase in Fibrosis stage from 3 to 4 as defined by NASH CRN. |
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 | Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48 | Week 48 | The Full Analysis Set included all participants who were randomized into the study and received at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Event-Free Survival (EFS) at Week 240 as Assessed by Time to First Clinical Event | Week 240 | No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint. | ||
| SECONDARY | Percentage of Participants Who Had Progression to Cirrhosis at Week 48 | Week 48 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 240 | Week 240 | No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint. | ||
| SECONDARY | Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48 | Week 48 | Participants in the Full Analysis Set were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 240 | Week 240 | No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint. | ||
| SECONDARY | Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 48 | Week 48 | Participants in the Full Analysis Set with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 240 | Week 240 | No data was analyzed as the study was terminated and no participants reached the Week 240 timepoint. |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48 | SEL 18 mg | 9.6 | 95% Confidence Interval 6.6 to 13.4 | percentage of participants | |
Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48 | SEL 6 mg | 12.1 | 95% Confidence Interval 8.8 to 16.2 | percentage of participants | |
Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis According to the Nonalcoholic Steatohepatitis (NASH) Clinical Research Network (CRN) Classification Without Worsening of NASH at Week 48 | Placebo | 13.2 | 95% Confidence Interval 8.4 to 19.5 | percentage of participants | |
| Percentage of Participants Who Had Progression to Cirrhosis at Week 48 | SEL 18 mg | 13.0 | 95% Confidence Interval 9.6 to 17.2 | percentage of participants | |
| Percentage of Participants Who Had Progression to Cirrhosis at Week 48 | SEL 6 mg | 15.6 | 95% Confidence Interval 11.8 to 20.0 | percentage of participants | |
| Percentage of Participants Who Had Progression to Cirrhosis at Week 48 | Placebo | 15.7 | 95% Confidence Interval 10.4 to 22.3 | percentage of participants | |
| Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48 | SEL 18 mg | 12.7 | 95% Confidence Interval 9.3 to 16.9 | percentage of participants | |
| Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48 | SEL 6 mg | 13.7 | 95% Confidence Interval 10.1 to 18.0 | percentage of participants | |
| Percentage of Participants Who Had a ≥ 1-Stage Improvement in Fibrosis at Week 48 | Placebo | 16.4 | 95% Confidence Interval 11.0 to 23.0 | percentage of participants | |
| Percentage of Participants Who Had NASH Resolution Without Worsening of Fibrosis at Week 48 | SEL 18 mg | 5.0 | 95% Confidence Interval 2.9 to 7.9 | percentage of participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow24
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Randomized Phase | STARTED | SEL 18 mg | 324 | |
| Randomized Phase | STARTED | SEL 6 mg | 323 | |
| Randomized Phase | STARTED | Placebo | 161 | |
| Randomized Phase | STARTED | Open-Label SEL 18 mg | 0 | |
| Randomized Phase | COMPLETED | SEL 18 mg | 0 | |
| Randomized Phase | COMPLETED | SEL 6 mg | 0 | |
| Randomized Phase | COMPLETED | Placebo | 0 | |
| Randomized Phase | COMPLETED | Open-Label SEL 18 mg | 0 | |
| Randomized Phase | NOT COMPLETED | SEL 18 mg | 324 | |
| Randomized Phase | NOT COMPLETED | SEL 6 mg | 323 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 participant flowAdverse events572
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 | Abdominal distension | Gastrointestinal disorders | SEL 18 mg | 13 | 322 | |
| other | Abdominal distension | Gastrointestinal disorders | SEL 6 mg | 12 | 321 | |
| other | Abdominal distension | Gastrointestinal disorders | Placebo | 8 | 159 | |
| other | Abdominal distension | Gastrointestinal disorders | Open-Label SEL 18 mg | 2 | 99 | |
| other | Abdominal pain | Gastrointestinal disorders | SEL 18 mg | 22 | 322 | |
| other | Abdominal pain | Gastrointestinal disorders | SEL 6 mg | 27 | 321 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 15 | 159 | |
| other | Abdominal pain | Gastrointestinal disorders | Open-Label SEL 18 mg | 3 | 99 | |
| other | Abdominal pain upper | Gastrointestinal disorders | SEL 18 mg | 33 | 322 | |
| other | Abdominal pain upper | Gastrointestinal disorders | SEL 6 mg | 26 | 321 |
1 to 10 of 572Source ClinicalTrials.gov
See all 572 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SEL 18 mg | 0 | 322 |
| Total, all-cause mortality | SEL 6 mg | 0 | 321 |
| Total, all-cause mortality | Placebo | 0 | 159 |
| Total, all-cause mortality | Open-Label SEL 18 mg | 0 | 99 |
| Total, other adverse events | SEL 18 mg | 248 | 322 |
| Total, other adverse events | SEL 6 mg | 254 | 321 |
| Total, other adverse events | Placebo | 130 | 159 |
| Total, other adverse events | Open-Label SEL 18 mg | 48 | 99 |
| Total, serious adverse events | SEL 18 mg | 47 | 322 |
| Total, serious adverse events | SEL 6 mg | 36 | 321 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 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.
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