Trial · NCT04171765
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
NCT04171765, Phase 2, Terminated, Genentech, Inc.; results first posted 2024-04-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis. Trials, record NCT04171765. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04171765
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
- NCT number
- NCT04171765
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Genentech, Inc.
- Conditions
- Non-alcoholic Steatohepatitis
- Interventions
- Placebo, BFKB8488A
- First posted
- 2019-11-21
- Last updated
- 2024-04-16
- Results first posted
- 2024-04-16
- Limitations and caveats
- Because the study was terminated early, the interpretation of its data is limited, and early dropout may confound the results.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52 | Week 52 | Resolution of non-alcoholic steatohepatitis (NASH) is defined as a non-alcoholic fatty liver disease activity score (NAS) of 0-1 for inflammation, 0 for ballooning, and any value for steatosis as determined by a central reader. Worsening of fibrosis is defined as any increase in NASH Clinical Research Network (CRN) fibrosis stage as determined by a central reader. |
| Secondary | Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52 | Baseline, Week 16, Week 52 | |
| Secondary | Proportion of Participants With Improvement in Liver Histology From Baseline and no Worsening of Fibrosis at Week 52 | Week 52 | |
| Secondary | Proportion of Participants With Improvement in Liver Fibrosis of at Least One Stage, as Defined by NASH Clinical Research Network (CRN), and no Worsening of NASH at Week 52 | Week 52 |
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 | Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52 | Week 52 | The modified intent-to-treat (mITT) population was defined as all randomly allocated participants who received at least one dose of study drug or placebo. | Percentage of Participants | NUMBER |
| SECONDARY | Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52 | Baseline, Week 16, Week 52 | The mITT population was defined as all randomly allocated participants who received at least one dose of study drug or placebo. | percentage of hepatic fat fraction | MEAN |
| SECONDARY | Proportion of Participants With Improvement in Liver Histology From Baseline and no Worsening of Fibrosis at Week 52 | Week 52 | The mITT population was defined as all randomly allocated participants who received at least one dose of study drug or placebo. | Percentage of participants | NUMBER |
| SECONDARY | Proportion of Participants With Improvement in Liver Fibrosis of at Least One Stage, as Defined by NASH Clinical Research Network (CRN), and no Worsening of NASH at Week 52 | Week 52 | The mITT population was defined as all randomly allocated participants who received at least one dose of study drug or placebo. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52 | Placebo | 16.7 | 95% Confidence Interval 0.00 to 54.82 | Percentage of Participants | |
| Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52 | Fixed Dose 50 mg | 37.5 | 95% Confidence Interval 0.00 to 77.30 | Percentage of Participants | |
| Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52 | Fixed Dose 75 mg | 14.3 | 95% Confidence Interval 0.00 to 47.35 | Percentage of Participants | |
| Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52 | Fixed Dose 100 mg | 33.3 | 95% Confidence Interval 0.00 to 79.39 | Percentage of Participants | |
| Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52 | Placebo | Baseline | 20.15 | Standard Deviation 6.35 | percentage of hepatic fat fraction |
| Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52 | Fixed Dose 50 mg | Baseline | 20.67 | Standard Deviation 6.05 | percentage of hepatic fat fraction |
| Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52 | Fixed Dose 75 mg | Baseline | 19.30 | Standard Deviation 3.99 | percentage of hepatic fat fraction |
| Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52 | Fixed Dose 100 mg | Baseline | 18.12 | Standard Deviation 7.70 | percentage of hepatic fat fraction |
| Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52 | Placebo | Week 16 change from baseline | -3.47 | Standard Deviation 2.28 | percentage of hepatic fat fraction |
| Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52 | Fixed Dose 50 mg | Week 16 change from baseline | -8.20 | Standard Deviation 8.58 | percentage of hepatic fat fraction |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 13 | |
| Overall Study | STARTED | Fixed Dose 50 mg | 11 | |
| Overall Study | STARTED | Fixed Dose 75 mg | 11 | |
| Overall Study | STARTED | Fixed Dose 100 mg | 11 | |
| Overall Study | COMPLETED | Placebo | 8 | |
| Overall Study | COMPLETED | Fixed Dose 50 mg | 9 | |
| Overall Study | COMPLETED | Fixed Dose 75 mg | 7 | |
| Overall Study | COMPLETED | Fixed Dose 100 mg | 6 | |
| Overall Study | NOT COMPLETED | Placebo | 5 | |
| Overall Study | NOT COMPLETED | Fixed Dose 50 mg | 2 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events456
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 | Placebo | 0 | 13 | 0 |
| other | Vertigo | Ear and labyrinth disorders | Fixed Dose-50mg BFKB8488A | 1 | 11 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Fixed Dose-75mg BFKB8488A | 1 | 11 | 1 |
| other | Vertigo | Ear and labyrinth disorders | Fixed Dose-100mg BFKB8488A | 0 | 11 | 0 |
| other | Cataract | Eye disorders | Placebo | 0 | 13 | 0 |
| other | Cataract | Eye disorders | Fixed Dose-50mg BFKB8488A | 1 | 11 | 1 |
| other | Cataract | Eye disorders | Fixed Dose-75mg BFKB8488A | 0 | 11 | 0 |
| other | Cataract | Eye disorders | Fixed Dose-100mg BFKB8488A | 0 | 11 | 0 |
| other | Retinal tear | Eye disorders | Placebo | 0 | 13 | 0 |
| other | Retinal tear | Eye disorders | Fixed Dose-50mg BFKB8488A | 1 | 11 | 1 |
1 to 10 of 456Source ClinicalTrials.gov
See all 456 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 13 |
| Total, all-cause mortality | Fixed Dose-50mg BFKB8488A | 0 | 11 |
| Total, all-cause mortality | Fixed Dose-75mg BFKB8488A | 0 | 11 |
| Total, all-cause mortality | Fixed Dose-100mg BFKB8488A | 0 | 11 |
| Total, other adverse events | Placebo | 9 | 13 |
| Total, other adverse events | Fixed Dose-50mg BFKB8488A | 11 | 11 |
| Total, other adverse events | Fixed Dose-75mg BFKB8488A | 9 | 11 |
| Total, other adverse events | Fixed Dose-100mg BFKB8488A | 10 | 11 |
| Total, serious adverse events | Placebo | 0 | 13 |
| Total, serious adverse events | Fixed Dose-50mg BFKB8488A | 1 | 11 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42892346 | 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/NCT04171765
GET https://conductscience.org/api/trials/v1/NCT04171765/results?page=2