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Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BFKB8488A in Otherwise Healthy Overweight and Obese Participants With Likely Insulin Resistance

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ClinicalTrials.gov Identifier: NCT02593331
Recruitment Status : Completed
First Posted : November 1, 2015
Last Update Posted : May 1, 2018
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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Brief Summary:
This study will evaluate the safety and tolerability profile of BFKB8488A following subcutaneous (SC) administration in overweight and obese participants (body mass index [BMI] greater than [>] 27 to less than or equal to [</=] 40 kilograms per square meter [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. Additionally, following the ascending fixed-dose SC cohorts, a separate cohort will open to evaluate the PK of BFKB8488A after intravenous (IV) administration.

Condition or disease Intervention/treatment Phase
Insulin Resistance Drug: BFKB8488A Other: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 79 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (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 and Intravenous BFKB8488A in Otherwise Healthy Overweight and Obese Volunteers With Likely Insulin Resistance
Actual Study Start Date : October 29, 2015
Actual Primary Completion Date : March 28, 2017
Actual Study Completion Date : March 28, 2017
Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: Placebo
Participants will receive placebo matching to BFKB8488A.
 Other: Placebo
Participants will receive a single dose of placebo on Day 1.
Experimental: BFKB8488A SC
Participants will receive single ascending SC dose of BFKB8488A in each dose escalation cohort.
 Drug: BFKB8488A
Participants will receive either a single escalated dose of BFKB8488A administered SC or a single dose of BFKB8488A administered IV on Day 1.
Experimental: BFKB8488A IV
Participants will receive single IV dose of BFKB8488A.
 Drug: BFKB8488A
Participants will receive either a single escalated dose of BFKB8488A administered SC or a single dose of BFKB8488A administered IV on Day 1.


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events [ Time Frame: From baseline up to 20 Weeks ]

Secondary Outcome Measures :
  1. Serum BFKB8488A Concentration [ Time Frame: SC Cohort: predose (Hour 0), 4, 24, 72 hours post Day 1 dose, Days 6, 8, 11, 15, 22, 29, 36, 43, 57, 85, 113; IV Cohort: end of infusion on Day 1, 1, 2, 4, 6, 8, 12, 24, 36, 48, 72 hours post Day 1 dose, Days 6, 8, 15, 22, 29, 36, 43 ]

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

Inclusion Criteria:

  • Participants with BMI >/=30 kg/m^2 and </=40 kg/m^2 or BMI >27 kg/m^2 and <30 kg/m^2 and Homeostatic Model Assessment-Insulin Resistance (HOMA-IR) >3.60 or waist circumference >100 centimeters (cm) (males) or 88 cm (females) or fasting plasma insulin >/=15 milli international unit per liter (mIU/L) or fasting plasma glucose >/=100 milligrams per deciliter (mg/dL) and <126 mg/dL or hemoglobin A1c (HbA1c) >5.6 percent (%) 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
  • Participants actively involved in a weight loss or dietary program within the last 6 months
  • History of surgical procedures for weight loss
  • History of eating disorder
  • Uncontrolled hypertension (systolic >/=140 millimeter of mercury [mmHg] or diastolic blood pressure >/=90 mmHg) either on or off therapy at screening or Day -2
  • Fasting triglycerides >500 mg/dL (5.64 millimoles per liter [mmol/L]) or low density lipoprotein (LDL) >160 mg/dL (4.14 mmol/L) at screening
  • Any serious medical condition or abnormality in clinical laboratory tests
Contacts and Locations
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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): NCT02593331


Locations
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United States, California
Profil Institute for Clinical Research Inc.
Chula Vista, California, United States, 91911
Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT02593331    
Other Study ID Numbers: GC29819
First Posted: November 1, 2015    Key Record Dates
Last Update Posted: May 1, 2018
Last Verified: April 2018
Additional relevant MeSH terms:
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Insulin Resistance
Overweight
Body Weight
 Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases