A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese Subjects
NCT ID: NCT00537420
Last Updated: 2008-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
551 participants
INTERVENTIONAL
2007-10-31
2008-09-30
Brief Summary
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Detailed Description
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Secondary Objectives:
* To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo
* To compare the weight loss post 12 and 24 weeks of treatment for each of the three nasal PYY3 36 dose groups versus the nasal placebo group
* To compare the proportion of patients who lose at least 5% and 10% of the baseline body weight post 12 and 24 weeks of therapy for each of the three nasal PYY3 36 dose groups versus the nasal placebo group
* To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with sibutramine versus capsule placebo
* To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with nasal placebo versus capsule placebo
* To compare the weight loss and proportion of patients who lose at least 5% of the baseline body weight post 12 and 24 weeks of treatment with sibutramine versus the nasal PYY3 36 dose groups
* To evaluate the effect of 12 and 24 weeks of treatment with nasal PYY3 36 and sibutramine on fasting lipid profile, plasma glucose, insulin, blood pressure and pulse, waist circumference and BMI
* To evaluate the effect of 24 weeks of treatment with nasal PYY3 36 and sibutramine on HbA1c levels
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
DOUBLE
Study Groups
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1
Nasal Placebo
Nasal Placebo
Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.
2
Capsule Placebo
Placebo Capsule
Placebo capsules will be taken once daily with or without food.
3
Nasal PYY3-36 200 ug
PYY3-36
Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.
4
Nasal PYY3-36 400 ug
PYY3-36
Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
5
Nasal PYY3-36 600 ug
PYY3-36
Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
6
Sibutramine 10 mg
Sibutramine
Sibutramine will be taken once daily with or without food
Interventions
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Nasal Placebo
Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.
Placebo Capsule
Placebo capsules will be taken once daily with or without food.
PYY3-36
Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.
PYY3-36
Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
PYY3-36
Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
Sibutramine
Sibutramine will be taken once daily with or without food
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* BMI 30-43 kg/m2, inclusive;
* In good health, determined by medical history and physical examination, as well as normal 12-lead ECG and vital signs;
* Non-smoker and no use of tobacco or nicotine products for at least 3 months;
* Females will be non-pregnant, non-lactating, and either post-menopausal for at least 1 year, surgically sterile (including tubal ligation, hysterectomy) for at least 3 months, until 30 days following Study Completion be willing to use an approved method of contraception;
* Has normal nasal mucosa.
Exclusion Criteria
* Serious Medical Condition
* Serious Psychiatric illness
* Organic causes of obesity (e.g. untreated hypothyroidism)
* Type 1 or Type 2 Diabetes;
* Presence of uncontrolled hypertension
* On prohibited concomitant medication
18 Years
65 Years
ALL
No
Sponsors
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Nastech Pharmaceutical Company, Inc.
INDUSTRY
Responsible Party
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Nastech Pharmaceutical Company, Inc.
Principal Investigators
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Gordon Brandt, M.D.
Role: STUDY_DIRECTOR
Nastech Pharmaceutical Company, Inc.
Locations
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For additional information regarding investigative sites for this trial, contact 1-425-415-3011
Peoria, Arizona, United States
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Phoenix, Arizona, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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Carmichael, California, United States
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Orange, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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San Diego, California, United States
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San Francisco, California, United States
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Pembroke Pines, Florida, United States
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Atlanta, Georgia, United States
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Augusta, Georgia, United States
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Evansville, Indiana, United States
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Valparaiso, Indiana, United States
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Baton Rouge, Louisiana, United States
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Brooklyn Center, Minnesota, United States
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Las Vegas, Nevada, United States
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Manlius, New York, United States
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Charlotte, North Carolina, United States
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Raleigh, North Carolina, United States
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Cleveland, Ohio, United States
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Reading, Pennsylvania, United States
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Greer, South Carolina, United States
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Mt. Pleasant, South Carolina, United States
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Austin, Texas, United States
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San Antonio, Texas, United States
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Temple, Texas, United States
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Salt Lake City, Utah, United States
Countries
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Other Identifiers
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C07-002
Identifier Type: -
Identifier Source: org_study_id