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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03060538
Recruitment Status : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : November 28, 2019
Information provided by (Responsible Party):
Genentech, Inc.

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Non-Alcoholic Fatty Liver Disease Drug: BFKB8488A Other: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : March 5, 2017
Estimated Primary Completion Date : December 13, 2019
Estimated Study Completion Date : December 13, 2019

Arm Intervention/treatment
Experimental: 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.
Drug: BFKB8488A
Administered subcutaneously starting on Day 1 and according to dosing schedule.
Other Name: RO7040551

Placebo Comparator: Placebo
Participants will receive BFKB8488A-matching placebo.
Other: Placebo
Administered subcutaneously starting on Day 1 and according to dosing schedule.

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. Serum BFKB8488A Concentration [ Time Frame: On multiple days during treatment period and follow-up (up to 18 weeks following first dose administration) ]
  2. 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) ]
    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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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.

Exclusion Criteria:

  • 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
  • Any serious medical condition or abnormality in clinical laboratory tests

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03060538

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United States, Alabama
Pinnacle Research Group Cullman
Anniston, Alabama, United States, 36207
Pinnacle Research Group; Llc, Central
Anniston, Alabama, United States, 36207
United States, California
Southern California Research Center, Inc.
Coronado, California, United States, 92118
Inland Empire Liver Foundation
Rialto, California, United States, 92377
Stanford Health Care
Stanford, California, United States, 94305
Diabetes Research Center
Tustin, California, United States, 92780
United States, Florida
MD Clinical
Hallandale Beach, Florida, United States, 33009
Premier Research Associate, Inc
Miami, Florida, United States, 33165
United States, Georgia
Agile Clinical Research Trials
Atlanta, Georgia, United States, 30328
United States, Kansas
MidWest Clinical Research
Overland Park, Kansas, United States, 66209
United States, New Jersey
Hassman Research Institute
Berlin, New Jersey, United States, 08009
United States, North Carolina
Carolina Research Center at Jones Family Practice
Shelby, North Carolina, United States, 28150
United States, Tennessee
New Orleans Center for Clinical Research
Knoxville, Tennessee, United States, 37920
United States, Texas
Texas Clinical Research Institute, LLC
Arlington, Texas, United States, 76012
Dallas Diabetes & Endocrine Center
Dallas, Texas, United States, 75230
Clinical Trials of Texas Incorporated
San Antonio, Texas, United States, 78229
Northeast Clinical Research of San Antonio LLC
San Antonio, Texas, United States, 78249
Consano Clinical Research
Shavano Park, Texas, United States, 78231
Canada, Quebec
inVentiv Health Clinical
Montreal, Quebec, Canada, H3X 2H9
Sponsors and Collaborators
Genentech, Inc.
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Study Director: Clinical Trials Hoffmann-La Roche

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Responsible Party: Genentech, Inc. Identifier: NCT03060538     History of Changes
Other Study ID Numbers: GC39547
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: November 28, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Digestive System Diseases