Safety and Tolerability of BVS857 in Subjects With Insulin Resistance

Novartis

Status and phase: Completed; Phase 1

Conditions: Insulin Resistance

Treatments: Drug: Placebo; Drug: BVS857

Study type: Interventional

Funder types: Industry

Identifiers

NCT01435330

CBVS857X2101

Details and patient eligibility

About

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

Enrollment: 43 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: Accepts Healthy Volunteers

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/exclusion criteria may apply

Trial design

43 participants in 2 patient groups, including a placebo group

BVS857

Experimental group

Treatment:

Drug: BVS857

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo