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
NCT ID: NCT03060538
Last Updated: 2020-03-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
154 participants
INTERVENTIONAL
2017-03-05
2019-12-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Multiple Ascending Dose BFKB8488A
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.
BFKB8488A
Administered subcutaneously starting on Day 1 and according to dosing schedule.
Placebo
Participants will receive BFKB8488A-matching placebo.
Placebo
Administered subcutaneously starting on Day 1 and according to dosing schedule.
Interventions
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BFKB8488A
Administered subcutaneously starting on Day 1 and according to dosing schedule.
Placebo
Administered subcutaneously starting on Day 1 and according to dosing schedule.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
* Any serious medical condition or abnormality in clinical laboratory tests
18 Years
75 Years
ALL
No
Sponsors
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Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Pinnacle Research Group Cullman
Anniston, Alabama, United States
Pinnacle Research Group; Llc, Central
Anniston, Alabama, United States
Southern California Research Center, Inc.
Coronado, California, United States
Stanford Health Care
Stanford, California, United States
Diabetes Research Center
Tustin, California, United States
MD Clinical
Hallandale, Florida, United States
Premier Research Associate, Inc
Miami, Florida, United States
Agile Clinical Research Trials
Atlanta, Georgia, United States
MidWest Clinical Research
Overland Park, Kansas, United States
Hassman Research Institute
Berlin, New Jersey, United States
Carolina Research Center at Jones Family Practice
Shelby, North Carolina, United States
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Texas Clinical Research Institute, LLC
Arlington, Texas, United States
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States
Clinical Trials of Texas Incorporated
San Antonio, Texas, United States
Northeast Clinical Research of San Antonio LLC
San Antonio, Texas, United States
Consano Clinical Research
Shavano Park, Texas, United States
inVentiv Health Clinical
Montreal, Quebec, Canada
Countries
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References
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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.
Other Identifiers
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GC39547
Identifier Type: -
Identifier Source: org_study_id
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