Trial · NCT02781584
Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)
NCT02781584, Phase 2, Completed, Gilead Sciences; results first posted 2022-02-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH). Trials, record NCT02781584. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02781584
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, and Efficacy of Selonsertib, Firsocostat, and Cilofexor in Adults With Nonalcoholic Steatohepatitis (NASH)
- NCT number
- NCT02781584
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 220 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Nonalcoholic Steatohepatitis (NASH), Nonalcoholic Fatty Liver Disease (NAFLD)
- Interventions
- SEL, FIR, CILO, FENO, VAS
- First posted
- 2016-05-24
- Last updated
- 2022-03-16
- Results first posted
- 2022-02-02
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Experienced Treatment-Emergent Adverse Events | Cohorts 1-9: First dose date up to 12 weeks plus 30 days; Cohorts 10-11: First dose date up to 26 weeks plus 30 days; Cohorts 12-13: First dose date up to 8 weeks plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. | Treatment-emergent AEs were defined as events that met 1 or both of the following criteria: * Any AEs with onset dates on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug * Any AEs leading to premature discontinuation of study drug |
| Primary | Percentage of Participants Who Experienced Treatment Emergent Serious Adverse Events | Cohorts 1-9: First dose date up to 12 weeks plus 30 days; Cohorts 10-11: First dose date up to 26 weeks plus 30 days; Cohorts 12-13: First dose date up to 8 weeks plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. | A treatment emergent serious adverse event (SAE) was defined as an event that, at any dose, results in the following: * Death * Life-threatening * In-patient hospitalization or prolongation of existing hospitalization * Persistent or significant disability/incapacity * A congenital anomaly/birth defect * A medically important event or reaction |
| Primary | Percentage of Participants Who Experienced Grade 3 or Higher Laboratory Abnormalities | Cohorts 1-9: First dose date up to 12 weeks plus 30 days; Cohorts 10-11: First dose date up to 26 weeks plus 30 days; Cohorts 12-13: First dose date up to 8 weeks plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. | Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any postbaseline time point, up to and including the date of last dose of study drug plus 30 days for subjects who permanently discontinued study drug. If baseline laboratory data were missing, then any abnormality of at least Grade 1 was considered treatment emergent. Graded laboratory abnormalities were defined using the grading scheme in the Common Terminology Criteria for Adverse Events (CTCAE) Version 4.03 for Cohorts 1-9 and CTCAE Version 5.0 for Cohorts 10-13. |
Source ClinicalTrials.gov
Outcomes3
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 Experienced Treatment-Emergent Adverse Events | Cohorts 1-9: First dose date up to 12 weeks plus 30 days; Cohorts 10-11: First dose date up to 26 weeks plus 30 days; Cohorts 12-13: First dose date up to 8 weeks plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. | The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced Treatment Emergent Serious Adverse Events | Cohorts 1-9: First dose date up to 12 weeks plus 30 days; Cohorts 10-11: First dose date up to 26 weeks plus 30 days; Cohorts 12-13: First dose date up to 8 weeks plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. | The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Experienced Grade 3 or Higher Laboratory Abnormalities | Cohorts 1-9: First dose date up to 12 weeks plus 30 days; Cohorts 10-11: First dose date up to 26 weeks plus 30 days; Cohorts 12-13: First dose date up to 8 weeks plus 30 days. For Cohorts 10-13, the first dose date included the Pre-treatment Phase. | The Safety Analysis Set included all participants who were administered at least 1 dose of the study drug. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group39
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 Experienced Treatment-Emergent Adverse Events | Cohort 1: SEL 18 mg (Non-cirrhotic) | 50 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events | Cohort 2: FIR 20 mg (Non-cirrhotic) | 60 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events | Cohort 3: CILO 30 mg (Non-cirrhotic) | 50 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events | Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic) | 25 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events | Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic) | 40 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events | Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic) | 50 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events | Cohort 7: CILO 20 mg (Cirrhotic) | 80 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events | Cohort 8: CILO 30 mg (Cirrhotic) | 70 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events | Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic) | 76.92 | percentage of participants | ||
| Percentage of Participants Who Experienced Treatment-Emergent Adverse Events | Cohort 10: FIR 20 mg + FENO 48 mg | 86.67 | percentage of participants |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 results by groupParticipant flow78
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-treatment Phase | STARTED | Cohort 1: SEL 18 mg (Non-cirrhotic) | 0 | |
| Pre-treatment Phase | STARTED | Cohort 2: FIR 20 mg (Non-cirrhotic) | 0 | |
| Pre-treatment Phase | STARTED | Cohort 3: CILO 30 mg (Non-cirrhotic) | 0 | |
| Pre-treatment Phase | STARTED | Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic) | 0 | |
| Pre-treatment Phase | STARTED | Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic) | 0 | |
| Pre-treatment Phase | STARTED | Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic) | 0 | |
| Pre-treatment Phase | STARTED | Cohort 7: CILO 20 mg (Cirrhotic) | 0 | |
| Pre-treatment Phase | STARTED | Cohort 8: CILO 30 mg (Cirrhotic) | 0 | |
| Pre-treatment Phase | STARTED | Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic) | 0 | |
| Pre-treatment Phase | STARTED | Cohort 10: FIR 20 mg + FENO 48 mg | 15 |
1 to 10 of 78Source ClinicalTrials.gov
See all 78 participant flowAdverse events1,430
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 | Anaemia | Blood and lymphatic system disorders | Cohort 1: SEL 18 mg (Non-cirrhotic) | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 2: FIR 20 mg (Non-cirrhotic) | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 3: CILO 30 mg (Non-cirrhotic) | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic) | 0 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic) | 0 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic) | 0 | 20 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 7: CILO 20 mg (Cirrhotic) | 2 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 8: CILO 30 mg (Cirrhotic) | 0 | 10 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic) | 0 | 13 | |
| other | Anaemia | Blood and lymphatic system disorders | Cohort 10: FIR 20 mg + FENO 48 mg | 0 | 15 |
1 to 10 of 1,430Source ClinicalTrials.gov
See all 1,430 adverse eventsAdverse event totals39
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1: SEL 18 mg (Non-cirrhotic) | 0 | 10 |
| Total, all-cause mortality | Cohort 2: FIR 20 mg (Non-cirrhotic) | 0 | 10 |
| Total, all-cause mortality | Cohort 3: CILO 30 mg (Non-cirrhotic) | 0 | 10 |
| Total, all-cause mortality | Cohort 4: SEL 18 mg + CILO 30 mg (Non-cirrhotic) | 0 | 20 |
| Total, all-cause mortality | Cohort 5: SEL 18 mg + FIR 20 mg (Non-cirrhotic) | 0 | 20 |
| Total, all-cause mortality | Cohort 6: CILO 30 mg + FIR 20 mg (Non-cirrhotic) | 0 | 20 |
| Total, all-cause mortality | Cohort 7: CILO 20 mg (Cirrhotic) | 0 | 10 |
| Total, all-cause mortality | Cohort 8: CILO 30 mg (Cirrhotic) | 0 | 10 |
| Total, all-cause mortality | Cohort 9: SEL 18 mg + FIR 20 mg + CILO 30 mg (Non-cirrhotic) | 0 | 13 |
| Total, all-cause mortality | Cohort 10: FIR 20 mg + FENO 48 mg | 0 | 15 |
1 to 10 of 39Source ClinicalTrials.gov
See all 39 adverse event totalsPapers2
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/NCT02781584
GET https://conductscience.org/api/trials/v1/NCT02781584/results?page=2