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 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
1 other identifier
interventional
154
2 countries
18
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1 diabetes-mellitus-type-2
Started Mar 2017
Longer than P75 for phase_1 diabetes-mellitus-type-2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2017
CompletedFirst Posted
Study publicly available on registry
February 23, 2017
CompletedStudy Start
First participant enrolled
March 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 13, 2019
CompletedMarch 27, 2020
March 1, 2020
2.8 years
February 17, 2017
March 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 18 weeks following first dose administration
Secondary Outcomes (2)
Serum BFKB8488A Concentration
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)
On multiple days during treatment period and follow-up (up 18 weeks following first dose administration)
Study Arms (2)
Multiple Ascending Dose BFKB8488A
EXPERIMENTALParticipants 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 COMPARATORParticipants will receive BFKB8488A-matching placebo.
Interventions
Eligibility Criteria
You may qualify if:
- 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
- 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.
You may not qualify if:
- 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
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Genentech, Inc.lead
Study Sites (18)
Pinnacle Research Group Cullman
Anniston, Alabama, 36207, United States
Pinnacle Research Group; Llc, Central
Anniston, Alabama, 36207, United States
Southern California Research Center, Inc.
Coronado, California, 92118, United States
Stanford Health Care
Stanford, California, 94305, United States
Diabetes Research Center
Tustin, California, 92780, United States
MD Clinical
Hallandale, Florida, 33009, United States
Premier Research Associate, Inc
Miami, Florida, 33165, United States
Agile Clinical Research Trials
Atlanta, Georgia, 30328, United States
MidWest Clinical Research
Overland Park, Kansas, 66209, United States
Hassman Research Institute
Berlin, New Jersey, 08009, United States
Carolina Research Center at Jones Family Practice
Shelby, North Carolina, 28150, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, 37920, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, 76012, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, 75230, United States
Clinical Trials of Texas Incorporated
San Antonio, Texas, 78229, United States
Northeast Clinical Research of San Antonio LLC
San Antonio, Texas, 78249, United States
Consano Clinical Research
Shavano Park, Texas, 78231, United States
inVentiv Health Clinical
Montreal, Quebec, H3X 2H9, Canada
Related Publications (1)
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.
PMID: 35993161DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2017
First Posted
February 23, 2017
Study Start
March 5, 2017
Primary Completion
December 13, 2019
Study Completion
December 13, 2019
Last Updated
March 27, 2020
Record last verified: 2020-03