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CompletedNCT01435330Updated Apr 24, 2015

Safety and Tolerability of BVS857 in Subjects With Insulin Resistance

A Phase 1 interventional study of BVS857 and Placebo in Insulin Resistance, sponsored by Novartis Pharmaceuticals. Completed at 2 sites in United States. Open to participants aged 18 Years to 64 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-24.

Sponsored by Novartis Pharmaceuticals · Phase 1 and Interventional

Phase
Phase 1
Study type
Interventional
Enrollment
43
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Insulin Resistance

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Keywords

  • Safety
  • BVS857
  • insulin resistance
03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 43 is close to the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.

Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

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

05

Study design

Phase
Phase 1
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
43 participants (actual)

Study arms

  • Experimental
    BVS857

    Drug: BVS857

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugBVS857
  • DrugPlacebo
06

What researchers measure

Primary outcomes

  1. Blood glucose

    Time frame: Continuously up to 48 hours

07

Study locations

2 sites
  • Novartis Investigative Site
    Chula Vista, California 91910, United States
  • Novartis Investigative Site
    Tacoma, Washington 98418, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01435330
Lead sponsor
Novartis Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 16, 2011
Start date
Mar 2011
Primary completion
Mar 2012
Completion
Mar 2012
Last update
Apr 24, 2015

Study contacts

Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2015. You cannot join it, but the record below documents what was studied.

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