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OpenTrials
Completed

NCT Number: NCT00094146

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

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.

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Key information

Conditions

Primary Insulin Hypersecretion Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New Orleans Center for Clinical Research, New Orleans, Louisiana, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sandostatin LAR Depot

Drug

Primary outcomes

  1. The percent change at baseline compared to 6 months in body weight

Secondary outcomes

  1. Compare changes from baseline and at 6 months in body mass index (BMI), percentage of total body fat percentage of abdominal fat, leptin, and waist-to-hip ratio

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Important dates

Study start
2002
Study completion
2002
First posted
Oct 15, 2004
Registry last updated
Sep 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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