Safety and Tolerability of BVS857 in Subjects With Insulin Resistance

A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study to Explore the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Parenterally Administered BVS857 in Healthy Subjects Without and With Insulin Resistance

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01435330

Enrollment

Registered

2011-09-16

Start date

2011-03-31

Completion date

2012-03-31

Last updated

2015-04-24

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

Conditions

Insulin Resistance

Keywords

Safety, BVS857, insulin resistance

Brief summary

The study will assess the safety, tolerability, drug label and effect in subjects with and without insulin resistance.

Interventions

DRUGBVS857

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

Healthy volunteers

Yes

Inclusion criteria

* Healthy male and female subjects with insulin resistance * Subjects with controlled hypertension and hyperlipidemia

Exclusion criteria

* Smokers * History of drug or alcohol use * Autonomic dysfunction * Significant illness or cardiovascular disease * Immunodeficiency disease Other protocol-defined inclusion/

Design outcomes

Primary

Measure	Time frame
Blood glucose	Continuously up to 48 hours

Countries

United States

Outcome results

None listed

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