Non-alcoholic SteatohepatitisPhase 2BANFFNCT04171765
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Participants With Non-Alcoholic Steatohepatitis
A Phase 2 study testing BFKB8488A in people with Non-alcoholic Steatohepatitis, run by Genentech, Inc. at 53 sites in 5 countries.
Trial summary
This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Non-alcoholic Steatohepatitis
- What is being tested?
- BFKB8488A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 53 sitesin 5 countries
- Study dates
- 30 Sep 2020to 23 Jan 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed diagnosis of NASH as documented through liver biopsy performed no more than 6 months before randomization, defined according to NASH CRN criteria along with a NASH CRN fibrosis score between F2 and F3
- Hepatic steatosis on MRI (>= 8% average PDFF) prior to randomization
Who cannot join
- History of any liver disease other than NASH, except for resolved, self-limited illnesses such as Hepatitis A or E, and previous Hepatitis C
- Weight gain > 10% or loss > 5% within 3 months prior to randomization
- History of liver transplantation
- Current or history of significant alcohol consumption
Trial locations and contacts
53 sites in 5 countries.
53 sites in 5 countries
United States39 sites
Pinnacle Clinical Research - Austin
Austin, Texas, 78746
Gastroenterology Associates, LLC
Baton Rouge, Louisiana, 70809
Walter Reed Army Medical Center
Bethesda, Maryland, 20889-0001
Excel Medical Research
Boca Raton, Florida, 33434
Texas Digetive Disease Consultants - Austin
Cedar Park, Texas, 78613
Arizona Liver Health - Chandler
Chandler, Arizona, 85224
Gregory Wiener, MD
Chula Vista, California, 91910
Wexner Medical Center; Ohio State University; Investigational Drug Services; Pharmacy Department
Columbus, Ohio, 43210-1228
Avant Research Associates, LLC
Crowley, Louisiana, 70526
Cullman Clinical Trials
Cullman, Alabama, 35055
Duke Medical Center; Gen Clinic Research Ctr
Durham, North Carolina, 27710
Liver Institute at Renaissance
Edinburg, Texas, 78539
South Texas Research Institute
Edinburg, Texas, 78539
South Denver Gastroenterology
Englewood, Colorado, 80113
Texas Digestive Disease Consultant - Ft Worth (TDDC - Ft Worth)
Fort Worth, Texas, 76104
Community Cancer Institute (CCI)
Fresno, California, 93720
Liver Associates of Texas - Houston
Houston, Texas, 77030
Grand Teton Research Group, PLLC
Idaho Falls, Idaho, 83404
Kansas City Research Institute, LLC
Kansas City, Missouri, 64131
National Research Inst.
Los Angeles, California, 90057
Gastrointestinal Specialists of Georgia, PC
Marietta, Georgia, 30060
Premier Research Associate, Inc
Miami, Florida, 33165
Arkansas Gastroenterology
North Little Rock, Arkansas, 72117
Conquest Clinical Research
Orange, California, 92886
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Amici Clinical Research
Raritan, New Jersey, 08869
Virginia Commonwealth University
Richmond, Virginia, 23219-1901
Hunter Holmes McGuire V.A. Medical Center
Richmond, Virginia, 23249
Quality Research Inc
San Antonio, Texas, 78209
American Research Corporation Inc.
San Antonio, Texas, 78215
Clinical Trials of Texas, Inc
San Antonio, Texas, 78229
Pinnacle Clinical Research - San Antonio
San Antonio, Texas, 78229
UC San Diego Airway Research and Clinical Trials Center
San Diego, California, 92103
Texas Digestive Disease Consultants - San Marcos
San Marcos, Texas, 78666
National Research Institute - Panorama City
Santa Monica, California, 90402
Covenant Research
Sarasota, Florida, 34240
Arizona Liver Health - Tucson
Tucson, Arizona, 85711
Orange Grove Family Practice
Tucson, Arizona, 85741
Huron Gastroenterology Associates
Ypsilanti, Michigan, 48197
France5 sites
CHU Hopitaux de Bordeaux
CHU Hopitaux de Bordeaux, 33000
Hospices Civils de Lyon
Lyon, 69004
CHU de Nice
Nice, 06602
Hopital Pitie-Salpetriere APHP
Paris, 75013
Hôpital d'Enfants, Service d?onco-hématologie pédiatrique
Vandœuvre-lès-Nancy, 54500
Spain5 sites
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Hospital Universtiario Virgen del Rocio
Seville, 41013
Hospital Clinico Universitario de Valencia; Servicio de Anatomia Patologica
Valencia, 46010
Consorcio Hospital General Universitario de Valencia
Valencia, 46014
Hospital Universitari i Politecnic La Fe; Servicio de Neurología
Valencia, 46026
Belgium3 sites
Hospital Erasme
Brussels, 1070
Antwerp University Hospital
Edegem, 2650
Universitair Ziekenhuis Gent
Ghent, 9000
About this study
Official title: A Phase II, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Patients With Non-Alcoholic Steatohepatitis
This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).
- Conditions
- Non-alcoholic Steatohepatitis
- Being tested
- Placebo, BFKB8488A
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Participants will receive subcutaneous (SC) placebo matched to BFKB8488A.
BFKB8488ADrug
Participants will receive subcutaneous (SC) BFKB8488A.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants will receive a fixed dose of placebo matched to BFKB8488A. Receives: Drug: Placebo |
| Fixed Dose: BFKB8488A Dose A | Experimental | Participants will receive BFKB8488A. Receives: Drug: BFKB8488A |
| Fixed Dose: BFKB8488A Dose B | Experimental | Participants will receive BFKB8488A. Receives: Drug: BFKB8488A |
| Fixed Dose: BFKB8488A Dose C | Experimental | Participants will receive BFKB8488A. Receives: Drug: BFKB8488A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at 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.
Measured: Week 52
Secondary outcomes (3)
Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52
Measured: Baseline, Week 16, Week 52
Proportion of Participants With Improvement in Liver Histology From Baseline and no Worsening of Fibrosis at Week 52
Measured: Week 52
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
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2019
- Study start30 Sep 2020
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Why it stopped: The study was terminated due to strategic business reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic SteatohepatitisStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04171765
- Sponsor's protocol ID
- GC41033
- Acronym
- BANFF
- Status last verified
- Apr 2024
- First submitted
- 19 Nov 2019
- Last updated
- 16 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).
Publications
Sanyal AJ, Zou Y, Zhang L, Dash A, Fredrickson J, Gutierrez J, Yoshida K, Liu Y, Kunder R, Wilson M, Wong C. Phase 2 study of fazpilodemab, a FGFR1/Klothobeta agonist, in metabolic dysfunction-associated steatohepatitis (MASH). JHEP Rep. 2026 Oct 17:102068. doi: 10.1016/j.jhepr.2026.102068. Online ahead of print.
PubMed 42892346
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of BFKB8488A Compared With Placebo in Patients With Non-Alcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT04171765
- Acronym / sponsor ID
- BANFF / GC41033
- Conditions
- Non-alcoholic Steatohepatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated due to strategic business reasons.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2020 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 21 Nov 2019 (actual)
- Results
- Posted 16 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate the efficacy, safety, and pharmacokinetics of BFKB8488A compared to placebo in participants with non-alcoholic steatohepatitis (NASH).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a fixed dose of placebo matched to BFKB8488A. |
| Fixed Dose: BFKB8488A Dose A | Experimental | Drug: BFKB8488AParticipants will receive BFKB8488A. |
| Fixed Dose: BFKB8488A Dose B | Experimental | Drug: BFKB8488AParticipants will receive BFKB8488A. |
| Fixed Dose: BFKB8488A Dose C | Experimental | Drug: BFKB8488AParticipants will receive BFKB8488A. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed diagnosis of NASH as documented through liver biopsy performed no more than 6 months before randomization, defined according to NASH CRN criteria along with a NASH CRN fibrosis score between F2 and F3
- Hepatic steatosis on MRI (>= 8% average PDFF) prior to randomization
Key exclusion criteria (4 listed)
- History of any liver disease other than NASH, except for resolved, self-limited illnesses such as Hepatitis A or E, and previous Hepatitis C
- Weight gain > 10% or loss > 5% within 3 months prior to randomization
- History of liver transplantation
- Current or history of significant alcohol consumption
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboParticipants will receive subcutaneous (SC) placebo matched to BFKB8488A. | Drug | Placebo |
| BFKB8488AParticipants will receive subcutaneous (SC) BFKB8488A. | Drug | Fixed Dose: BFKB8488A Dose A, Fixed Dose: BFKB8488A Dose B, Fixed Dose: BFKB8488A Dose C |
Primary outcome
Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52
Time frame: 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.
3 secondary outcomes
Change From Baseline in Hepatic Fat Fraction as Assessed by Magnetic Resonance Imaging-Derived Proton Density Fat Fraction (MRI-PDFF) at Week 52
Time frame: Baseline, Week 16, Week 52
Proportion of Participants With Improvement in Liver Histology From Baseline and no Worsening of Fibrosis at Week 52
Time frame: Week 52
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
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 42892346Sanyal AJ, Zou Y, Zhang L, Dash A, Fredrickson J, Gutierrez J, Yoshida K, Liu Y, Kunder R, Wilson M, Wong C. Phase 2 study of fazpilodemab, a FGFR1/Klothobeta agonist, in metabolic dysfunction-associated steatohepatitis (MASH). JHEP Rep. 2026 Oct 17:102068. doi: 10.1016/j.jhepr.2026.102068. Online ahead of print.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
53 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing BFKB8488A in people with Non-alcoholic Steatohepatitis, run by Genentech, Inc. at 53 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 16 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, France, Spain, Belgium, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Participants With NASH Resolution on Overall Histopathological Reading Without Worsening of Fibrosis at Week 52 (time frame: Week 52). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04171765, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2024.