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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02593331

Enrollment

Registered

2015-11-02

Start date

2015-10-29

Completion date

2017-03-28

Last updated

2018-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Insulin Resistance

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.

Interventions

DRUGBFKB8488A

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

OTHERPlacebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Percentage of Participants With Adverse Events	From baseline up to 20 Weeks

Secondary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026