Diabetes Mellitus, Type 2Phase 1NCT03060538
A Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus and Participants With Non-Alcoholic Fatty Liver Disease
A Phase 1 study testing BFKB8488A in people with Diabetes Mellitus, Type 2 and Non-Alcoholic Fatty Liver Disease, run by Genentech, Inc. at 18 sites in 2 countries.
Trial summary
This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending-dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus (T2DM) and participants with non-alcoholic fatty liver disease(NAFLD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Non-Alcoholic Fatty Liver Disease
- 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
- 154 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 5 Mar 2017to 13 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- For T2DM Cohort only:
- Body mass index (BMI) ≥ 27 kg/m2 and ≤ 40 kg/m2.
- A confirmed diagnosis of Type 2 diabetes ≥ 6 months at screening
- Current stable treatment (at least 3 months) for diabetes
- Hemoglobin A1c (HbA1c) ≥ 6.8% and ≤ 9.0%.
- For women of childbearing potential, agreement to remain abstinent or use reliable contraception during treatment period and for at least 42 days after last dose of study drug
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- For men, agreement to remain abstinent or use reliable contraception and agree to refrain from donating sperm
- For NAFLD cohort only:
- BMI ≥ 25 kg/m2 and ≤ 40 kg/m2
- At screening, confirmed liver fat by ultrasound OR calculated Liver Fat ≥ 10% using variables from the NAFLD liver fat score
- Hepatic steatosis on magnetic resonance imaging (MRI; ≥ 10% average liver proton density fat fraction [PDFF]) prior to randomization.
Who cannot join
- Pregnant, lactating, or intending to become pregnant within 42 days after the last dose of study drug is administered
- Suspected or confirmed diagnosis of Type 1 diabetes
- Significant cardiac disease
- Any psychiatric illness that increases the risk of participation in the study
- History of severe allergic, anaphylactic, or other hypersensitivity reactions, or severe systemic bacterial, fungal, or parasitic infections
- Poor peripheral venous access
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- Received blood products within 2 months before dosing
- Donation or loss of blood within 30-56 days prior to study drug administration
- Positive for hepatitis C virus (HCV) antibody, hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibody
- Liver enzymes greater than acceptable limits
- History of eating disorders or surgical procedures for weight loss
- Active participation in a structured weight loss or dietary program
- Treatment with investigational therapy or exposure to any biological therapy
- Illicit drug use, marijuana use, or alcohol abuse
- Current use of more than one pack of cigarettes a day or equivalent nicotine- containing products
- Any serious medical condition or abnormality in clinical laboratory tests
Trial locations and contacts
18 sites in 2 countries.
18 sites in 2 countries
United States17 sites
Pinnacle Research Group Cullman
Anniston, Alabama, 36207
Pinnacle Research Group; Llc, Central
Anniston, Alabama, 36207
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012
Agile Clinical Research Trials
Atlanta, Georgia, 30328
Hassman Research Institute
Berlin, New Jersey, 08009
Southern California Research Center, Inc.
Coronado, California, 92118
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230
MD Clinical
Hallandale, Florida, 33009
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920
Premier Research Associate, Inc
Miami, Florida, 33165
MidWest Clinical Research
Overland Park, Kansas, 66209
Clinical Trials of Texas Incorporated
San Antonio, Texas, 78229
Northeast Clinical Research of San Antonio LLC
San Antonio, Texas, 78249
Consano Clinical Research
Shavano Park, Texas, 78231
Carolina Research Center at Jones Family Practice
Shelby, North Carolina, 28150
Stanford Health Care
Stanford, California, 94305
Diabetes Research Center
Tustin, California, 92780
About this study
Official title: A Phase Ib, Randomized, Blinded, Placebo-Controlled, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous BFKB8488A in Patients With Type 2 Diabetes Mellitus and Patients With Non-Alcoholic Fatty Liver Disease
This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending-dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus (T2DM) and participants with non-alcoholic fatty liver disease(NAFLD). A maximum of approximately 160 participants will be enrolled across multiple sites in the United States. Participants will be randomly assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a screening period (up to 8 weeks), a 12-week treatment period, and a 6-week follow-up period. Participants may come to clinic for an optional pre-screening visit.
- Being tested
- BFKB8488A, Placebo
- Medical subject headings
- Diabetes Mellitus, Type 2, Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BFKB8488ADrug
Also called RO7040551
Administered subcutaneously starting on Day 1 and according to dosing schedule.
PlaceboOther
Administered subcutaneously starting on Day 1 and according to dosing schedule.
| Study group | Role | What they receive |
|---|---|---|
| Multiple Ascending Dose BFKB8488A | Experimental | Participants will be randomized to receive BFKB8488A. When adequate safety data are available, a review will be done for all participants to make a dose-escalation or dose and/or regimen modification decision. This will be repeated for each cohort. Receives: Drug: BFKB8488A |
| Placebo | Placebo comparator | Participants will receive BFKB8488A-matching placebo. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events (AE)
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
Measured: Up to 18 weeks following first dose administration
Secondary outcomes (2)
Serum BFKB8488A Concentration
Measured: On multiple days during treatment period and follow-up (up to 18 weeks following first dose administration)
Change from Baseline in Percentage of Participants with Anti-Therapeutic Antibodies (ATAs)
Participants are considered to be ATA positive if they are ATA negative at baseline but develop an ATA response following study drug administration (treatment-induced ATA response), or if they are ATA positive at baseline and at least one post-baseline samples if above acceptable limits. The number and percentage of ATA-positive and ATA-negative participants will be summarized by treatment group.
Measured: On multiple days during treatment period and follow-up (up 18 weeks following first dose administration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start5 Mar 2017
- Primary completion13 Dec 2019
- Study completion13 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 154 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
- NCT03060538
- Sponsor's protocol ID
- GC39547
- Status last verified
- Mar 2020
- First submitted
- 17 Feb 2017
- Last updated
- 27 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Wong C, Dash A, Fredrickson J, Lewin-Koh N, Chen S, Yoshida K, Liu Y, Gutierrez J, Kunder R. Fibroblast growth factor receptor 1/Klothobeta agonist BFKB8488A improves lipids and liver health markers in patients with diabetes or NAFLD: A phase 1b randomized trial. Hepatology. 2023 Sep 1;78(3):847-862. doi: 10.1002/hep.32742. Epub 2022 Sep 12.
PubMed 35993161
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Randomized, Blinded, Placebo-Controlled, Multiple Ascending-Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous BFKB8488A in Patients With Type 2 Diabetes Mellitus and Patients With Non-Alcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03060538
- Acronym / sponsor ID
- GC39547
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2017 (actual)
- Primary completion
- 13 Dec 2019 (actual)
- Study completion
- 13 Dec 2019 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase Ib, randomized, blinded, placebo-controlled, multiple ascending-dose study of the safety, tolerability, pharmacokinetic (PK), and pharmacodynamic (PD) effects of BFKB8488A in participants with Type 2 diabetes mellitus (T2DM) and participants with non-alcoholic fatty liver disease(NAFLD). A maximum of approximately 160 participants will be enrolled across multiple sites in the United States. Participants will be randomly assigned to receive study drug (active BFKB8488A or placebo). The study will consist of a screening period (up to 8 weeks), a 12-week treatment period, and a 6-week follow-up period. Participants may come to clinic for an optional pre-screening visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multiple Ascending Dose BFKB8488A | Experimental | Drug: BFKB8488AParticipants will be randomized to receive BFKB8488A. When adequate safety data are available, a review will be done for all participants to make a dose-escalation or dose and/or regimen modification decision. This will be repeated for each cohort. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive BFKB8488A-matching placebo. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Body mass index (BMI) ≥ 27 kg/m2 and ≤ 40 kg/m2.
- A confirmed diagnosis of Type 2 diabetes ≥ 6 months at screening
- Current stable treatment (at least 3 months) for diabetes
- Hemoglobin A1c (HbA1c) ≥ 6.8% and ≤ 9.0%.
- For women of childbearing potential, agreement to remain abstinent or use reliable contraception during treatment period and for at least 42 days after last dose of study drug
Key exclusion criteria (16 listed)
- Pregnant, lactating, or intending to become pregnant within 42 days after the last dose of study drug is administered
- Suspected or confirmed diagnosis of Type 1 diabetes
- Significant cardiac disease
- Any psychiatric illness that increases the risk of participation in the study
- History of severe allergic, anaphylactic, or other hypersensitivity reactions, or severe systemic bacterial, fungal, or parasitic infections
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 |
|---|---|---|
| BFKB8488AAlso: RO7040551Administered subcutaneously starting on Day 1 and according to dosing schedule. | Drug | Multiple Ascending Dose BFKB8488A |
| PlaceboAdministered subcutaneously starting on Day 1 and according to dosing schedule. | Other | Placebo |
Primary outcome
Percentage of Participants with Adverse Events (AE)
Time frame: Up to 18 weeks following first dose administration
An adverse event is any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product, regardless of causal attribution.
2 secondary outcomes
Serum BFKB8488A Concentration
Time frame: On multiple days during treatment period and follow-up (up to 18 weeks following first dose administration)
Change from Baseline in Percentage of Participants with Anti-Therapeutic Antibodies (ATAs)
Time frame: On multiple days during treatment period and follow-up (up 18 weeks following first dose administration)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2020.
- Derived from this study: PubMed 35993161Wong C, Dash A, Fredrickson J, Lewin-Koh N, Chen S, Yoshida K, Liu Y, Gutierrez J, Kunder R. Fibroblast growth factor receptor 1/Klothobeta agonist BFKB8488A improves lipids and liver health markers in patients with diabetes or NAFLD: A phase 1b randomized trial. Hepatology. 2023 Sep 1;78(3):847-862. doi: 10.1002/hep.32742. Epub 2022 Sep 12.
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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
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BFKB8488A in people with Diabetes Mellitus, Type 2 and Non-Alcoholic Fatty Liver Disease, run by Genentech, Inc. at 18 sites in 2 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 11 inclusion and 16 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: finished, as of the sponsor's last update on 27 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Canada. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Percentage of Participants with Adverse Events (AE) (time frame: Up to 18 weeks following first dose administration). 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 NCT03060538, 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 27 Mar 2020.