Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
Trial record 1 of 2 for:    BFKB8488A
Previous Study | Return to List | Next Study

Study to Explore the Safety, Tolerability and Pharmacokinetics of Subcutaneous Administration of BFKB8488A in Otherwise Healthy Overweight and Obese Volunteers

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2016 by Genentech, Inc.
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.
ClinicalTrials.gov Identifier:
NCT02593331
First received: October 20, 2015
Last updated: November 1, 2016
Last verified: November 2016
  Purpose
This study will evaluate the safety and tolerability profile of BFKB8488A following subcutaneous (SC) administration in overweight and obese subjects (body mass index [BMI] 27-40 kg/m^2) with markers of insulin resistance. Single ascending fixed doses of BFKB8488A will be evaluated. Participants will be randomized into 7 sequential ascending fixed-dose cohorts of BFKB8488A SC or placebo and safety reviews will be performed before escalation to higher dose cohorts.

Condition Intervention Phase
Insulin Resistance
Drug: BFKB8488A
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase Ia, Randomized, Blinded, Placebo-Controlled, Ascending Single Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Subcutaneous BFKB8488A in Otherwise Healthy Overweight and Obese Volunteers With Likely Insulin Resistance

Further study details as provided by Genentech, Inc.:

Primary Outcome Measures:
  • Percentage of Participants With Adverse Events [ Time Frame: From baseline up to 20 weeks ]
  • Percentage of Participants With Clinically Significant Changes in Safety Measurements Following BFKB8488A Administration, Including Vital Signs, Physical Findings, and Clinical Laboratory Results [ Time Frame: Up to 20 weeks following first dose administration ]

Secondary Outcome Measures:
  • Serum BFKB8488A Concentration [ Time Frame: On multiple days during the follow-up period that is up to 20 weeks. ]
  • Percentage of participants with confirmed anti-BFKB8488A antibodies [ Time Frame: From baseline to end of study up to approximately 20 weeks ]

Estimated Enrollment: 70
Study Start Date: October 2015
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: March 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Control
Placebo will be administered to subjects randomized to the placebo arm of each dose escalation cohort.
Other: Placebo
Participants will receive a single dose of placebo administered subcutaneously.
Experimental: Single Ascending Dose BFKB8488A
BFKB8488A will be administered to subjects randomized to the experimental arm of each dose escalation cohort.
Drug: BFKB8488A
Participants will receive a single, escalated dose of BFKB8488A administered subcutaneously.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and women between the ages of 18 and 65.
  • BMI > 27.0 kg/m^2 and <=40 kg/m^2 AND BMI >= 32 kg/m^2 OR HOMA-IR > 3.60 OR Waist circumference >100 cm (males) or 88 cm (females) OR Fasting plasma insulin >=15 mIU/L OR Fasting plasma glucose >=100 mg/dl and <126 mg/dl OR HbA1c >5.6% and <6.5%.
  • Negative pregnancy test.

Exclusion Criteria:

  • A diagnosis of Type 2 diabetes mellitus at any time.
  • Pregnant, lactating or intending to become pregnant during the study or within 3 months after the study dose is administered.
  • Uncontrolled intercurrent illness or any psychiatric illness.
  • Actively involved in a weight loss or dietary program within the last 6 months.
  • History of surgical procedures for weight loss.
  • History of eating disorders.
  • Uncontrolled hypertension (systolic >= 140 mmHg or diastolic blood pressure >= 90 mmHg) either on or off therapy at screening or Day -2.
  • Fasting triglycerides > 500 mg/dL (5.64 mmol/L) or LDL > 160 mg/dL (4.14 mmol/L) at screening.
  • Any serious medical condition or abnormality in clinical laboratory tests.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02593331

Contacts
Contact: Reference Study ID Number: GC29819 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global.rochegenentechtrials@roche.com

Locations
United States, California
Recruiting
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Genentech, Inc.
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02593331     History of Changes
Other Study ID Numbers: GC29819
Study First Received: October 20, 2015
Last Updated: November 1, 2016

Additional relevant MeSH terms:
Overweight
Insulin Resistance
Body Weight
Signs and Symptoms
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 21, 2017