Overview

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

Status:
Completed

Trial end date:
2017-03-28

Target enrollment:
0

Participant gender:
All

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 [Phase: Phase 1

Accepts Healthy Volunteers?

Accepts Healthy Volunteers

Details

Lead Sponsor:

Genentech, Inc.

Criteria

Inclusion Criteria:

- Participants with BMI >/=30 kg/m^2 and 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