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Sponsored by: |
Nastech Pharmaceutical Company, Inc. |
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Information provided by: | Nastech Pharmaceutical Company, Inc. |
ClinicalTrials.gov Identifier: | NCT00537420 |
The purpose of this study is to determine the effect of nasal PYY3-36 on weight loss post 24 weeks of treatment.
Condition | Intervention | Phase |
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Obesity |
Drug: Nasal Placebo Drug: Placebo Capsule Drug: PYY3-36 Drug: Sibutramine |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study |
Official Title: | A 24-Week, Blinded, Randomized, Placebo-Controlled Dose-Ranging Trial of Nasal PYY3-36 for Weight Loss in Healthy Obese Patients |
Enrollment: | 551 |
Study Start Date: | October 2007 |
Study Completion Date: | September 2008 |
Primary Completion Date: | July 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Nasal Placebo
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Drug: Nasal Placebo
Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.
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2: Placebo Comparator
Capsule Placebo
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Drug: Placebo Capsule
Placebo capsules will be taken once daily with or without food.
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3: Experimental
Nasal PYY3-36 200 ug
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Drug: PYY3-36
Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.
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4: Experimental
Nasal PYY3-36 400 ug
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Drug: PYY3-36
Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
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5: Experimental
Nasal PYY3-36 600 ug
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Drug: PYY3-36
Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
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6: Active Comparator
Sibutramine 10 mg
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Drug: Sibutramine
Sibutramine will be taken once daily with or without food
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This is a multi-center, Phase 2 double-blind, randomized, placebo-controlled trial in healthy obese patients. The primary objective of the study is to evaluate the effect of increasing nasal PYY3-36 dosing on weight loss post 24 weeks of treatment.
Secondary Objectives:
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Study Director: | Gordon Brandt, M.D. | Nastech Pharmaceutical Company, Inc. |
Responsible Party: | Nastech Pharmaceutical Company, Inc. ( Gordon Brandt, M.D. / President ) |
Study ID Numbers: | C07-002 |
Study First Received: | September 28, 2007 |
Last Updated: | September 12, 2008 |
ClinicalTrials.gov Identifier: | NCT00537420 History of Changes |
Health Authority: | United States: Food and Drug Administration |
weight loss dieting |
Obesity Psychotropic Drugs Overweight Healthy Body Weight Sibutramine Signs and Symptoms |
Anti-Obesity Agents Weight Loss Body Weight Changes Nutrition Disorders Appetite Depressants Overnutrition Antidepressive Agents |
Obesity Psychotropic Drugs Overweight Pharmacologic Actions Body Weight Sibutramine Signs and Symptoms Anti-Obesity Agents |
Therapeutic Uses Weight Loss Body Weight Changes Nutrition Disorders Appetite Depressants Overnutrition Central Nervous System Agents Antidepressive Agents |