Trial · NCT03987074
Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)
NCT03987074, Phase 2, Completed, Gilead Sciences; results first posted 2021-07-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH). Trials, record NCT03987074. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03987074
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety, Tolerability, and Efficacy of Monotherapy and Combination Regimens in Participants With Nonalcoholic Steatohepatitis (NASH)
- NCT number
- NCT03987074
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Nonalcoholic Steatohepatitis
- Interventions
- Semaglutide, Firsocostat, Cilofexor
- First posted
- 2019-06-14
- Last updated
- 2021-07-15
- Results first posted
- 2021-07-15
Source ClinicalTrials.gov
Registered outcomes2
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 Week 24 plus 30 days | Treatment-emergent adverse events (TEAEs) were defined as, any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug. Participants were assessed for AEs according to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Primary | Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | First dose date up to 24 weeks plus 30 days | Treatment-emergent laboratory abnormalities, defined as values that increase at least one toxicity grade from baseline at any time post-baseline up to and including the date of last dose of study drug plus 30 days, were summarized by treatment group. Graded laboratory abnormalities were defined using the grading scheme in the CTCAE 5.0. |
Source ClinicalTrials.gov
Outcomes2
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 Week 24 plus 30 days | The Safety Analysis Set included participants who received 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 24 weeks plus 30 days | Participants in the Safety Analysis Set were analyzed. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group25
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) | Semaglutide | 81.0 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Semaglutide + Firsocostat 20 mg | 86.4 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Semaglutide + Cilofexor 30 mg | 81.8 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Semaglutide + Cilofexor 100 mg | 72.7 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs) | Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg | 90.5 | percentage of participants | ||
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Semaglutide | Grade 1 | 61.9 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Semaglutide + Firsocostat 20 mg | Grade 1 | 63.6 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Semaglutide + Cilofexor 30 mg | Grade 1 | 36.4 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Semaglutide + Cilofexor 100 mg | Grade 1 | 50.0 | percentage of participants | |
| Percentage of Participants Experiencing Treatment-Emergent Laboratory Abnormalities | Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg | Grade 1 | 66.7 | percentage of participants |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Semaglutide | 21 | |
| Overall Study | STARTED | Semaglutide + Firsocostat 20 mg | 22 | |
| Overall Study | STARTED | Semaglutide + Cilofexor 30 mg | 22 | |
| Overall Study | STARTED | Semaglutide + Cilofexor 100 mg | 22 | |
| Overall Study | STARTED | Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg | 21 | |
| Overall Study | COMPLETED | Semaglutide | 18 | |
| Overall Study | COMPLETED | Semaglutide + Firsocostat 20 mg | 20 | |
| Overall Study | COMPLETED | Semaglutide + Cilofexor 30 mg | 21 | |
| Overall Study | COMPLETED | Semaglutide + Cilofexor 100 mg | 18 | |
| Overall Study | COMPLETED | Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg | 19 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events160
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 | Vision blurred | Eye disorders | Semaglutide | 0 | 21 | |
| other | Vision blurred | Eye disorders | Semaglutide + Firsocostat 20 mg | 0 | 22 | |
| other | Vision blurred | Eye disorders | Semaglutide + Cilofexor 30 mg | 2 | 22 | |
| other | Vision blurred | Eye disorders | Semaglutide + Cilofexor 100 mg | 0 | 22 | |
| other | Vision blurred | Eye disorders | Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg | 0 | 21 | |
| other | Visual impairment | Eye disorders | Semaglutide | 0 | 21 | |
| other | Visual impairment | Eye disorders | Semaglutide + Firsocostat 20 mg | 2 | 22 | |
| other | Visual impairment | Eye disorders | Semaglutide + Cilofexor 30 mg | 0 | 22 | |
| other | Visual impairment | Eye disorders | Semaglutide + Cilofexor 100 mg | 0 | 22 | |
| other | Visual impairment | Eye disorders | Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg | 0 | 21 |
1 to 10 of 160Source ClinicalTrials.gov
See all 160 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Semaglutide | 0 | 21 |
| Total, all-cause mortality | Semaglutide + Firsocostat 20 mg | 0 | 22 |
| Total, all-cause mortality | Semaglutide + Cilofexor 30 mg | 0 | 22 |
| Total, all-cause mortality | Semaglutide + Cilofexor 100 mg | 0 | 22 |
| Total, all-cause mortality | Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg | 0 | 21 |
| Total, other adverse events | Semaglutide | 16 | 21 |
| Total, other adverse events | Semaglutide + Firsocostat 20 mg | 17 | 22 |
| Total, other adverse events | Semaglutide + Cilofexor 30 mg | 18 | 22 |
| Total, other adverse events | Semaglutide + Cilofexor 100 mg | 13 | 22 |
| Total, other adverse events | Semaglutide + Firsocostat 20 mg + Cilofexor 30 mg | 17 | 21 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 35439567 | 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/NCT03987074
GET https://conductscience.org/api/trials/v1/NCT03987074/results?page=2