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

Completed · Phase 1 · Has a placebo group

Conditions studied: Insulin Resistance

In brief

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.

Key facts

Study ID

NCT02593331

Run by

Genentech, Inc.

People needed

79

Starts

2015-10-29

Expected to finish

2017-03-28

Last updated by the study team

2018-05-01

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Profil Institute for Clinical Research Inc. — Chula Vista, California, United States

Full record on ClinicalTrials.gov

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