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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-29

Study Completion Date

2017-03-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Safety Study of LLF580 in Obese Volunteers

NCT03466203

Obesity

COMPLETED PHASE1

Safety, Pharmacokinetics and Potential Activity of HE3286 in Obese Adult Subjects

NCT00555451

Insulin Resistance

COMPLETED PHASE1

A Study to Test How Well Different Doses of BI 3006337 Are Tolerated by People With Overweight or Obesity and With Fatty Liver Disease

NCT05970640

Non-alcoholic Fatty Liver Disease Obesity

COMPLETED PHASE1

Investigation of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Multiple Dosing of NNC0174-0833 in Subjects With Obesity or Overweight

NCT02958085

Metabolism and Nutrition Disorder Obesity

COMPLETED PHASE1

Efficacy and Safety of KAI-9531 Administered Once Weekly in Participants Living With Obesity or Overweight and Diabetes

NCT07284901

Obesity With Diabetes Overweight With Diabetes

RECRUITING PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Insulin Resistance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Placebo

Participants will receive placebo matching to BFKB8488A.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

BFKB8488A SC

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

Group Type EXPERIMENTAL

BFKB8488A

Intervention Type DRUG

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

BFKB8488A IV

Participants will receive single IV dose of BFKB8488A.

Group Type EXPERIMENTAL

BFKB8488A

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BFKB8488A

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

Intervention Type DRUG

Placebo

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes