Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BFKB8488A in Otherwise Healthy Overweight and Obese Participants With Likely Insulin Resistance
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 5/3/2018 |
| Start Date: | October 29, 2015 |
| End Date: | March 28, 2017 |
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
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 [ 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.
subcutaneous (SC) administration in overweight and obese participants (body mass index [BMI]
greater than [>] 27 to less than or equal to [ 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.
Inclusion Criteria:
- Participants with BMI >/=30 kg/m^2 and 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
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