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CompletedNCT00094146Updated Sep 22, 2009

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

A Phase 2 interventional study of Sandostatin LAR Depot in Primary Insulin Hypersecretion and Obesity, sponsored by Novartis. Completed at 3 sites in United States. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2009-09-22.

Sponsored by Novartis · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
160
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Primary Insulin Hypersecretion
  • Obesity

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Keywords

  • Primary Insulin Hypersecretion
  • PIH
  • Obesity
03

In context

Obesity

6,296 studies on the registry are indexed under Obesity; 1,692 are open to participants now.

This study's enrollment of 160 is above the median of 78 across 4,878 interventional studies indexed under Obesity.

Browse Obesity studies →

Lead sponsor

Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
160 participants

Interventions

  • DrugSandostatin LAR Depot
06

What researchers measure

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

07

Study locations

3 sites
  • New Orleans Center for Clinical Research
    New Orleans, Louisiana, United States
  • University of Tennessee
    Memphis, Tennessee 38103, United States
  • University of Wisconsin Beers-Murphy Clinical Nutrition Clinic
    Madison, Wisconsin 537052, United States
08

References and documents

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00094146
Lead sponsor
Novartis
First posted
Oct 15, 2004
Start date
Jan 2002
Completion
Dec 2002
Last update
Sep 22, 2009

Study contacts

Jennifer Hedrick, MBA
study director · Novartis
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2004. You cannot join it, but the record below documents what was studied.

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