Trial · NCT04971785
Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
NCT04971785, Phase 2, Completed, Gilead Sciences; results first posted 2025-11-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH). Trials, record NCT04971785. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04971785
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Semaglutide, and Cilofexor/Firsocostat, Alone and in Combination, in Adults With Cirrhosis Due to Nonalcoholic Steatohepatitis (NASH)
- NCT number
- NCT04971785
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 457 participants, actual
- Lead sponsor
- Gilead Sciences
- Conditions
- Nonalcoholic Steatohepatitis
- Interventions
- Semaglutide (SEMA), Cilofexor (CILO)/Firsocostat (FIR), PTM SEMA, PTM CILO/FIR
- First posted
- 2021-07-21
- Last updated
- 2025-11-26
- Other registries' IDs
- eudract:2021-001445-12
- Results first posted
- 2025-11-26
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Who Achieved ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 72 in Semaglutide (SEMA) + Cilofexor/Firsocostat (CILO/FIR) Fixed Dose Combination (FDC) Versus Placebo Groups | Week 72 | Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH clinical research network (CRN) classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off. |
| Secondary | Percentage of Participants Who Achieved ≥1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 72 in SEMA + CILO/FIR FDC Versus SEMA Alone | Week 72 | Fibrosis improvement was defined as ≥ 1-stage decrease from baseline in fibrosis according to the NASH CRN classification. Worsening of NASH was defined as ≥ 1-point increase from baseline in hepatocellular ballooning or lobular inflammation. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off. |
| Secondary | Percentage of Participants With NASH Resolution Without Worsening in Fibrosis at Week 72 in SEMA + CILO/FIR FDC Versus Placebo Groups | Week 72 | NASH resolution is defined as lobular inflammation of 0 or 1 and hepatocellular ballooning of 0. Worsening in fibrosis was defined as a change in fibrosis worsening stage as per NASH CRN criteria. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off. |
| Secondary | Percentage of Participants With NASH Resolution Without Worsening in Fibrosis In Participants Treated With SEMA + CILO/FIR FDC Versus CILO/FIR Alone Groups | Week 72 | NASH resolution is defined as lobular inflammation of 0 or 1 and hepatocellular ballooning of 0. Worsening in fibrosis was defined as a change in fibrosis worsening stage as per NASH CRN criteria. Clopper-Pearson method was used in outcome measure analysis in each arm. Percentages were rounded-off. |
Source ClinicalTrials.gov
Outcomes4
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 ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 72 in Semaglutide (SEMA) + Cilofexor/Firsocostat (CILO/FIR) Fixed Dose Combination (FDC) Versus Placebo Groups | Week 72 | Participants in the Full Analysis Set in SEMA + CILO/FIR FDC and PTM SEMA + PTM CILO/FIR were analyzed. The Full Analysis Set included all randomized participants who received at least 1 dose of study drug. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved ≥1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 72 in SEMA + CILO/FIR FDC Versus SEMA Alone | Week 72 | Participants in the Full Analysis Set in SEMA + CILO/FIR and SEMA + PTM CILO/FIR were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With NASH Resolution Without Worsening in Fibrosis at Week 72 in SEMA + CILO/FIR FDC Versus Placebo Groups | Week 72 | Participants in the Full Analysis Set in SEMA + CILO/FIR FDC and PTM SEMA + PTM CILO/FIR with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With NASH Resolution Without Worsening in Fibrosis In Participants Treated With SEMA + CILO/FIR FDC Versus CILO/FIR Alone Groups | Week 72 | Participants in the Full Analysis Set in SEMA + CILO/FIR FDC and PTM SEMA + CILO/FIR FDC with available data were analyzed. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
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 ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 72 in Semaglutide (SEMA) + Cilofexor/Firsocostat (CILO/FIR) Fixed Dose Combination (FDC) Versus Placebo Groups | SEMA + CILO/FIR FDC | 13.7 | 95% Confidence Interval 8.2 to 21.0 | percentage of participants | |
Percentage of Participants Who Achieved ≥ 1-Stage Improvement in Fibrosis Without Worsening of Nonalcoholic Steatohepatitis (NASH) at Week 72 in Semaglutide (SEMA) + Cilofexor/Firsocostat (CILO/FIR) Fixed Dose Combination (FDC) Versus Placebo Groups | PTM SEMA + PTM CILO/FIR | 8.3 | 95% Confidence Interval 3.4 to 16.4 | percentage of participants | |
| Percentage of Participants Who Achieved ≥1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 72 in SEMA + CILO/FIR FDC Versus SEMA Alone | SEMA + CILO/FIR FDC | 13.7 | 95% Confidence Interval 8.2 to 21.0 | percentage of participants | |
| Percentage of Participants Who Achieved ≥1-Stage Improvement in Fibrosis Without Worsening of NASH at Week 72 in SEMA + CILO/FIR FDC Versus SEMA Alone | SEMA + PTM CILO/FIR | 15.6 | 95% Confidence Interval 9.6 to 23.2 | percentage of participants | |
| Percentage of Participants With NASH Resolution Without Worsening in Fibrosis at Week 72 in SEMA + CILO/FIR FDC Versus Placebo Groups | SEMA + CILO/FIR FDC | 57.3 | 95% Confidence Interval 45.9 to 68.2 | percentage of participants | |
| Percentage of Participants With NASH Resolution Without Worsening in Fibrosis at Week 72 in SEMA + CILO/FIR FDC Versus Placebo Groups | PTM SEMA + PTM CILO/FIR | 22.4 | 95% Confidence Interval 11.8 to 36.6 | percentage of participants | |
| Percentage of Participants With NASH Resolution Without Worsening in Fibrosis In Participants Treated With SEMA + CILO/FIR FDC Versus CILO/FIR Alone Groups | SEMA + CILO/FIR FDC | 57.3 | 95% Confidence Interval 45.9 to 68.2 | percentage of participants | |
| Percentage of Participants With NASH Resolution Without Worsening in Fibrosis In Participants Treated With SEMA + CILO/FIR FDC Versus CILO/FIR Alone Groups | PTM SEMA + CILO/FIR FDC | 31.8 | 95% Confidence Interval 22.3 to 42.6 | percentage of participants |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | SEMA + CILO/FIR FDC | 125 | |
| Overall Study | STARTED | SEMA + PTM CILO/FIR | 124 | |
| Overall Study | STARTED | PTM SEMA + CILO/FIR FDC | 123 | |
| Overall Study | STARTED | PTM SEMA + PTM CILO/FIR | 85 | |
| Overall Study | COMPLETED | SEMA + CILO/FIR FDC | 103 | |
| Overall Study | COMPLETED | SEMA + PTM CILO/FIR | 104 | |
| Overall Study | COMPLETED | PTM SEMA + CILO/FIR FDC | 91 | |
| Overall Study | COMPLETED | PTM SEMA + PTM CILO/FIR | 65 | |
| Overall Study | NOT COMPLETED | SEMA + CILO/FIR FDC | 22 | |
| Overall Study | NOT COMPLETED | SEMA + PTM CILO/FIR | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events368
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 | SEMA + CILO/FIR FDC | 9 | 124 | |
| other | Abdominal distension | Gastrointestinal disorders | SEMA + PTM CILO/FIR | 10 | 122 | |
| other | Abdominal distension | Gastrointestinal disorders | PTM SEMA + CILO/FIR FDC | 4 | 123 | |
| other | Abdominal distension | Gastrointestinal disorders | PTM SEMA + PTM CILO/FIR | 6 | 84 | |
| other | Abdominal pain | Gastrointestinal disorders | SEMA + CILO/FIR FDC | 11 | 124 | |
| other | Abdominal pain | Gastrointestinal disorders | SEMA + PTM CILO/FIR | 10 | 122 | |
| other | Abdominal pain | Gastrointestinal disorders | PTM SEMA + CILO/FIR FDC | 6 | 123 | |
| other | Abdominal pain | Gastrointestinal disorders | PTM SEMA + PTM CILO/FIR | 11 | 84 | |
| other | Abdominal pain upper | Gastrointestinal disorders | SEMA + CILO/FIR FDC | 7 | 124 | |
| other | Abdominal pain upper | Gastrointestinal disorders | SEMA + PTM CILO/FIR | 11 | 122 |
1 to 10 of 368Source ClinicalTrials.gov
See all 368 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | SEMA + CILO/FIR FDC | 0 | 125 |
| Total, all-cause mortality | SEMA + PTM CILO/FIR | 1 | 124 |
| Total, all-cause mortality | PTM SEMA + CILO/FIR FDC | 1 | 123 |
| Total, all-cause mortality | PTM SEMA + PTM CILO/FIR | 0 | 85 |
| Total, other adverse events | SEMA + CILO/FIR FDC | 101 | 124 |
| Total, other adverse events | SEMA + PTM CILO/FIR | 97 | 122 |
| Total, other adverse events | PTM SEMA + CILO/FIR FDC | 85 | 123 |
| Total, other adverse events | PTM SEMA + PTM CILO/FIR | 60 | 84 |
| Total, serious adverse events | SEMA + CILO/FIR FDC | 17 | 124 |
| Total, serious adverse events | SEMA + PTM CILO/FIR | 13 | 122 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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/NCT04971785
GET https://conductscience.org/api/trials/v1/NCT04971785/events?page=2