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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.
 
ClinicalTrials.gov Identifier: NCT03060538
Recruitment Status : Active, not recruiting
First Posted : February 23, 2017
Last Update Posted : November 29, 2019
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Tracking Information
First Submitted Date  ICMJE February 17, 2017
First Posted Date  ICMJE February 23, 2017
Last Update Posted Date November 29, 2019
Actual Study Start Date  ICMJE March 5, 2017
Estimated Primary Completion Date December 13, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2017)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03060538 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2017)
  • 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) ]
    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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes Mellitus, Type 2
  • Non-Alcoholic Fatty Liver Disease
Intervention  ICMJE
  • Drug: BFKB8488A
    Administered subcutaneously starting on Day 1 and according to dosing schedule.
    Other Name: RO7040551
  • Other: Placebo
    Administered subcutaneously starting on Day 1 and according to dosing schedule.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: BFKB8488A
  • Placebo Comparator: Placebo
    Participants will receive BFKB8488A-matching placebo.
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 7, 2019)
154
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2017)
140
Estimated Study Completion Date  ICMJE December 13, 2019
Estimated Primary Completion Date December 13, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03060538
Other Study ID Numbers  ICMJE GC39547
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Genentech, Inc.
Study Sponsor  ICMJE Genentech, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Genentech, Inc.
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP