NCT02593331

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
79

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 20, 2015

Completed
9 days until next milestone

Study Start

First participant enrolled

October 29, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 2, 2015

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2017

Completed
Last Updated

May 1, 2018

Status Verified

April 1, 2018

Enrollment Period

1.4 years

First QC Date

October 20, 2015

Last Update Submit

April 30, 2018

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants With Adverse Events

    From baseline up to 20 Weeks

Secondary Outcomes (1)

  • 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

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Participants will receive placebo matching to BFKB8488A.

Other: Placebo

BFKB8488A SC

EXPERIMENTAL

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

Drug: BFKB8488A

BFKB8488A IV

EXPERIMENTAL

Participants will receive single IV dose of BFKB8488A.

Drug: BFKB8488A

Interventions

BFKB8488ADRUG

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

BFKB8488A IVBFKB8488A SC
PlaceboOTHER

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

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Profil Institute for Clinical Research Inc.

Chula Vista, California, 91911, United States

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Clinical Trials

    Hoffmann-La Roche

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 20, 2015

First Posted

November 2, 2015

Study Start

October 29, 2015

Primary Completion

March 28, 2017

Study Completion

March 28, 2017

Last Updated

May 1, 2018

Record last verified: 2018-04

Locations

US(1)