Trial · NCT02856555
Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis
NCT02856555, Phase 2, Completed, Gilead Sciences; results first posted 2020-07-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis. Trials, record NCT02856555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02856555
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study to Evaluate Safety, Tolerability, and Efficacy of GS-0976 in Adults With Nonalcoholic Steatohepatitis
- NCT number
- NCT02856555
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 127 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Nonalcoholic Steatohepatitis (NASH)
- Interventions
- Firsocostat, Placebo
- First posted
- 2016-08-05
- Last updated
- 2020-07-24
- Results first posted
- 2020-07-24
Source ClinicalTrials.gov
Registered outcomes1
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 | First Dose date up to last dose (Week 12) plus 30 days |
Source ClinicalTrials.gov
Outcomes1
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 | First Dose date up to last dose (Week 12) plus 30 days | The Safety Analysis Set included participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group3
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 | Firsocostat 5 mg | 70.6 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Firsocostat 20 mg | 71.4 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events | Placebo | 61.5 | percentage of participants |
Source ClinicalTrials.gov
Participant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Firsocostat 5 mg | 51 | |
| Overall Study | STARTED | Firsocostat 20 mg | 50 | |
| Overall Study | STARTED | Placebo | 26 | |
| Overall Study | COMPLETED | Firsocostat 5 mg | 46 | |
| Overall Study | COMPLETED | Firsocostat 20 mg | 46 | |
| Overall Study | COMPLETED | Placebo | 26 | |
| Overall Study | NOT COMPLETED | Firsocostat 5 mg | 5 | |
| Overall Study | NOT COMPLETED | Firsocostat 20 mg | 4 | |
| Overall Study | NOT COMPLETED | Placebo | 0 |
Source ClinicalTrials.gov
Adverse events66
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 | Nausea | Gastrointestinal disorders | Firsocostat 5 mg | 4 | 51 | |
| other | Nausea | Gastrointestinal disorders | Firsocostat 20 mg | 7 | 49 | |
| other | Nausea | Gastrointestinal disorders | Placebo | 2 | 26 | |
| other | Diarrhoea | Gastrointestinal disorders | Firsocostat 5 mg | 5 | 51 | |
| other | Diarrhoea | Gastrointestinal disorders | Firsocostat 20 mg | 6 | 49 | |
| other | Diarrhoea | Gastrointestinal disorders | Placebo | 0 | 26 | |
| other | Abdominal pain | Gastrointestinal disorders | Firsocostat 5 mg | 2 | 51 | |
| other | Abdominal pain | Gastrointestinal disorders | Firsocostat 20 mg | 5 | 49 | |
| other | Abdominal pain | Gastrointestinal disorders | Placebo | 1 | 26 | |
| other | Abdominal pain upper | Gastrointestinal disorders | Firsocostat 5 mg | 2 | 51 |
1 to 10 of 66Source ClinicalTrials.gov
See all 66 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Firsocostat 5 mg | 0 | 51 |
| Total, all-cause mortality | Firsocostat 20 mg | 0 | 49 |
| Total, all-cause mortality | Placebo | 0 | 26 |
| Total, other adverse events | Firsocostat 5 mg | 26 | 51 |
| Total, other adverse events | Firsocostat 20 mg | 29 | 49 |
| Total, other adverse events | Placebo | 11 | 26 |
| Total, serious adverse events | Firsocostat 5 mg | 2 | 51 |
| Total, serious adverse events | Firsocostat 20 mg | 2 | 49 |
| Total, serious adverse events | Placebo | 0 | 26 |
Source ClinicalTrials.gov
Papers2
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/NCT02856555
GET https://conductscience.org/api/trials/v1/NCT02856555/events?page=2