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

Sponsor

Genentech, Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT02593331

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance	Drug: BFKB8488A Other: Placebo	Phase 1

Study Design

Study Type:

Interventional

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 :

Oct 29, 2015

Actual Primary Completion Date :

Mar 28, 2017

Actual Study Completion Date :

Mar 28, 2017

Arms and Interventions

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.

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

Primary Outcome Measures

Percentage of Participants With Adverse Events [From baseline up to 20 Weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Profil Institute for Clinical Research Inc.	Chula Vista	California	United States	91911

Sponsors and Collaborators

Genentech, Inc.

Investigators

Study Director: Clinical Trials, Hoffmann-La Roche

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Genentech, Inc.

ClinicalTrials.gov Identifier:

NCT02593331

Other Study ID Numbers:

GC29819

First Posted:

Nov 1, 2015

Last Update Posted:

May 1, 2018

Last Verified:

Apr 1, 2018

Additional relevant MeSH terms:

Insulin Resistance

Overweight

Study Results

No Results Posted as of May 1, 2018