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

Primary Purpose

Insulin Resistance

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

BFKB8488A

Placebo

About this trial

This is an interventional treatment trial for Insulin Resistance

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Profil Institute for Clinical Research Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

BFKB8488A SC

BFKB8488A IV

Arm Description

Participants will receive placebo matching to BFKB8488A.

Participants will receive single ascending SC dose of BFKB8488A in each dose escalation cohort.

Participants will receive single IV dose of BFKB8488A.

Outcomes

Primary Outcome Measures

Percentage of Participants With Adverse Events

Secondary Outcome Measures

Serum BFKB8488A Concentration

Full Information

NCT ID

NCT02593331

First Posted

October 20, 2015

Last Updated

April 30, 2018

Sponsor

Genentech, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT02593331

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2018

Overall Recruitment Status

Completed

Study Start Date

October 29, 2015 (Actual)

Primary Completion Date

March 28, 2017 (Actual)

Study Completion Date

March 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Genentech, Inc.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

79 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Participants will receive placebo matching to BFKB8488A.

Arm Title

BFKB8488A SC

Arm Type

Experimental

Arm Description

Participants will receive single ascending SC dose of BFKB8488A in each dose escalation cohort.

Arm Title

BFKB8488A IV

Arm Type

Experimental

Arm Description

Participants will receive single IV dose of BFKB8488A.

Intervention Type

Drug

Intervention Name(s)

BFKB8488A

Intervention Description

Participants will receive either a single escalated dose of BFKB8488A administered SC or a single dose of BFKB8488A administered IV on Day 1.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Participants will receive a single dose of placebo on Day 1.

Primary Outcome Measure Information:

Title

Percentage of Participants With Adverse Events

Time Frame

From baseline up to 20 Weeks

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Profil Institute for Clinical Research Inc.

City

Chula Vista

State/Province

California

ZIP/Postal Code

91911

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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