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Sandostatin LAR Depot

Phase 2

Primary Insulin Hypersecretion | Small molecule | Metabolic |Novartis AG|Last Updated: Sep 22, 2009

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindUNCONTROLLED
Total Trials1
Total Enrollment160

FDA Designations

No designations recorded

Clinical trial landscape

Sandostatin LAR Depot · 1 trial · 2 indications

Phase 2 1
NCT00094146Sandostatin LAR® Depot in Patients With Primary Insulin Hypersecretion (PIH) and at Least Moderate ObesityPrimary Insulin Hypersecretion
COMPLETED160 Analytics
PHASE2COMPLETED
Sandostatin LAR® Depot in Patients With Primary Insulin Hypersecretion (PIH) and at Least Moderate Obesity
Primary Insulin HypersecretionUnlock trial analytics

Study Endpoints

Primary Endpoints

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

Secondary Endpoints

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
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Sandostatin LAR DepotDRUG -
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Eligibility Criteria

Age Range18 Years to 70 Years
SexALL
Healthy VolunteersNo
Study Sites3

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 to...

Countries:United States
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Frequently asked questions about Sandostatin LAR Depot

What is Sandostatin LAR Depot used for?

Sandostatin LAR Depot is used for primary insulin hypersecretion (PIH), a condition of excess insulin secretion, in patients who also have at least moderate obesity. It is being investigated as a treatment for this metabolic condition.

Who makes Sandostatin LAR Depot?

Sandostatin LAR Depot is developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS.

What phase is Sandostatin LAR Depot in?

Sandostatin LAR Depot is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is Sandostatin LAR Depot in?

Sandostatin LAR Depot has one completed Phase 2 clinical trial, identified as NCT00094146. This trial enrolled 160 participants with primary insulin hypersecretion and at least moderate obesity in the United States. The trial was randomized and double-blind.

Is Sandostatin LAR Depot the same as Sandostatin?

Sandostatin LAR Depot is a long-acting release formulation of Sandostatin (octreotide). While both contain the same active ingredient, Sandostatin LAR Depot is designed for slow release over time, whereas Sandostatin is an immediate-release formulation.