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

Phase 1

Completed

• Conditions: Insulin Resistance
• Interventions: Other: Placebo; Drug: BFKB8488A

• Registration Number: NCT02593331
• Lead Sponsor: Genentech, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-10-20
• Study Start: 2015-10-29
• Study First Submitted QC: 2015-10-30
• Study First Posted: 2015-11-01
• Primary Completion: 2017-03-28
• Study Completion: 2017-03-28
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-30
• Last Update Posted: 2018-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 79

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Participants will receive placebo matching to BFKB8488A.
BFKB8488A SC	BFKB8488A	Participants will receive single ascending SC dose of BFKB8488A in each dose escalation cohort.
BFKB8488A IV	BFKB8488A	Participants will receive single IV dose of BFKB8488A.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Adverse Events	From baseline up to 20 Weeks

Secondary Outcome Measures

Name	Time	Method
Serum BFKB8488A Concentration	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

Trial Locations

Locations (1)

Profil Institute for Clinical Research Inc.; 🇺🇸 Chula Vista, California, United States