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Sandostatin LAR® Depot in Patients With Primary Insulin Hypersecretion (PIH) and at Least Moderate Obesity

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Novartis

Status and phase

Completed
Phase 2

Conditions

Obesity
Primary Insulin Hypersecretion

Treatments

Drug: Sandostatin LAR Depot

Study type

Interventional

Funder types

Industry

Identifiers

NCT00094146
CSMS995GUS20
US20

Details and patient eligibility

About

This study is in patients with at least moderate obesity (Body Mass Index [BMI] > 30 kg/m2 or approximately 30 or more pounds overweight) and who also produce too much insulin (insulin stores sugar as fat). Sandostatin LAR® Depot suppresses insulin, and is being developed to help with weight loss in people who find it hard to lose weight on their own because they produce too much insulin.

The main purpose of the study is to find the lowest dose of Sandostatin LAR® Depot that safely helps overweight people lose weight. The study will also compare weight loss in obese patients who receive one of three different dosages of Sandostatin LAR Depot or placebo.

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

You may qualify for this study if you:

  • are between the ages of 18-70 (male or female)
  • are at least moderately obese (BMI > 30 kg/m2 or approximately 30 or more pounds overweight)
  • and pass an oral glucose tolerance test (a 3 hour test to determine if your body produces too much insulin)

Exclusion criteria

You are not qualified for this study if you:

  • have diabetes
  • have been able to lose weight with diet and exercise alone
  • have previously received Sandostatin LAR® Depot

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

Trial contacts and locations

3

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Data sourced from clinicaltrials.gov

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