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A Multiple Ascending Dose Study to Evaluate Safety and Tolerability of BFKB8488A in Participants With Type 2 Diabetes Mellitus

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ClinicalTrials.gov Identifier: NCT03060538
Recruitment Status : Recruiting
First Posted : February 23, 2017
Last Update Posted : April 30, 2018
Sponsor:
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. A maximum of approximately 140 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 Drug: BFKB8488A Other: Placebo Phase 1

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 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
Actual Study Start Date : March 5, 2017
Estimated Primary Completion Date : June 7, 2019
Estimated Study Completion Date : June 7, 2019

Resource links provided by the National Library of Medicine


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.



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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
Criteria

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

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 ClinicalTrials.gov identifier (NCT number): NCT03060538


Contacts
Contact: Reference Study ID Number: GC39547 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. Only) global-roche-genentech-trials@gene.com

Locations
United States, Alabama
Pinnacle Research Group; Llc, Central Recruiting
Anniston, Alabama, United States, 36207
United States, California
Southern California Research Center, Inc. Recruiting
Coronado, California, United States, 92118
National Research Inst. Terminated
Los Angeles, California, United States, 90057
Northern California Research Terminated
Sacramento, California, United States, 95821
Stanford Health Care Recruiting
Stanford, California, United States, 94305
Diabetes Research Center Recruiting
Tustin, California, United States, 92780
United States, Florida
MD Clinical Recruiting
Hallandale Beach, Florida, United States, 33009
Premier Research Associate, Inc Recruiting
Miami, Florida, United States, 33165
United States, Georgia
Agile Clinical Research Trials Recruiting
Atlanta, Georgia, United States, 30328
United States, New Jersey
Hassman Research Institute Recruiting
Berlin, New Jersey, United States, 08009
United States, New York
Diabetes Endocrinology Center of WNY Recruiting
Buffalo, New York, United States, 14221
United States, North Carolina
Carolina Research Center at Jones Family Practice Recruiting
Shelby, North Carolina, United States, 28150
United States, Tennessee
New Orleans Center for Clinical Research Recruiting
Knoxville, Tennessee, United States, 37920
United States, Texas
Dallas Diabetes & Endocrine Center Recruiting
Dallas, Texas, United States, 75230
Northeast Clinical Research of San Antonio LLC Recruiting
San Antonio, Texas, United States, 78249
Consano Clinical Research Recruiting
Shavano Park, Texas, United States, 78231
Canada, Quebec
inVentiv Health Clinical Recruiting
Montreal, Quebec, Canada, H3X 2H9
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT03060538     History of Changes
Other Study ID Numbers: GC39547
First Posted: February 23, 2017    Key Record Dates
Last Update Posted: April 30, 2018
Last Verified: April 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases