Trial · NCT03449446
Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
NCT03449446, Phase 2, Completed, Gilead Sciences; results first posted 2020-12-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH). Trials, record NCT03449446. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03449446
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study to Evaluate the Safety and Efficacy of Selonsertib, Firsocostat, Cilofexor, and Combinations in Participants With Bridging Fibrosis or Compensated Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
- NCT number
- NCT03449446
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 395 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Nonalcoholic Steatohepatitis
- Interventions
- SEL, FIR, CILO, Placebo to match FIR, Placebo to match CILO, Placebo to match SEL
- First posted
- 2018-02-28
- Last updated
- 2020-12-03
- Results first posted
- 2020-12-03
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 Experiencing Treatment-Emergent Adverse Events (TEAEs) | First dose date up to 48 weeks plus 30 days | |
| Primary | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | First dose date up to 48 weeks plus 30 days | Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. Participants with any laboratory abnormality were reported. |
| Primary | Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis 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 clinical research network classification (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. The 95% CI was based on the Clopper-Pearson method. |
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 Experiencing Treatment-Emergent Adverse Events (TEAEs) | First dose date up to 48 weeks plus 30 days | The Safety Analysis Set included all participants who took at least 1 dose of study drug. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | First dose date up to 48 weeks plus 30 days | Participants in the Safety Analysis Set with available data were analyzed. | percentage of participants | NUMBER |
| PRIMARY | Percentage of Participants Who Achieved a ≥ 1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 48 | Week 48 | Participants in the Full Analysis Set (included all participants who took at least 1 dose of study drug and were randomized into the study) with available data were analyzed. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group21
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Selonsertib | 84.6 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Firsocostat | 85.0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Cilofexor | 92.5 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | SEL + FIR | 88.6 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | SEL + CILO | 96.1 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | FIR + CILO | 91.0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Placebo | 79.5 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Selonsertib | 94.9 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Firsocostat | 100.0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Cilofexor | 97.5 | percentage of participants |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Selonsertib | 39 | |
| Overall Study | STARTED | Firsocostat | 40 | |
| Overall Study | STARTED | Cilofexor | 41 | |
| Overall Study | STARTED | SEL + FIR | 80 | |
| Overall Study | STARTED | SEL + CILO | 78 | |
| Overall Study | STARTED | FIR + CILO | 78 | |
| Overall Study | STARTED | Placebo | 39 | |
| Overall Study | COMPLETED | Selonsertib | 3 | |
| Overall Study | COMPLETED | Firsocostat | 33 | |
| Overall Study | COMPLETED | Cilofexor | 34 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events756
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 | Vertigo | Ear and labyrinth disorders | Selonsertib | 1 | 39 | |
| other | Vertigo | Ear and labyrinth disorders | Firsocostat | 1 | 40 | |
| other | Vertigo | Ear and labyrinth disorders | Cilofexor | 0 | 40 | |
| other | Vertigo | Ear and labyrinth disorders | SEL + FIR | 1 | 79 | |
| other | Vertigo | Ear and labyrinth disorders | SEL + CILO | 5 | 77 | |
| other | Vertigo | Ear and labyrinth disorders | FIR + CILO | 0 | 78 | |
| other | Vertigo | Ear and labyrinth disorders | Placebo | 2 | 39 | |
| other | Vision blurred | Eye disorders | Selonsertib | 0 | 39 | |
| other | Vision blurred | Eye disorders | Firsocostat | 1 | 40 | |
| other | Vision blurred | Eye disorders | Cilofexor | 0 | 40 |
1 to 10 of 756Source ClinicalTrials.gov
See all 756 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Selonsertib | 0 | 39 |
| Total, all-cause mortality | Firsocostat | 0 | 40 |
| Total, all-cause mortality | Cilofexor | 0 | 40 |
| Total, all-cause mortality | SEL + FIR | 0 | 79 |
| Total, all-cause mortality | SEL + CILO | 1 | 77 |
| Total, all-cause mortality | FIR + CILO | 0 | 78 |
| Total, all-cause mortality | Placebo | 0 | 39 |
| Total, other adverse events | Selonsertib | 30 | 39 |
| Total, other adverse events | Firsocostat | 30 | 40 |
| Total, other adverse events | Cilofexor | 34 | 40 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33169409 | 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/NCT03449446
GET https://conductscience.org/api/trials/v1/NCT03449446/results?page=2