A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese Subjects

• ClinicalTrials.gov Identifier: NCT00537420
• Recruitment Status: Completed
• First Posted: October 1, 2007
• Last Update Posted: September 15, 2008
• Sponsor: Nastech Pharmaceutical Company, Inc.
• Information provided by: Nastech Pharmaceutical Company, Inc.

Study Description

Brief Summary:

The purpose of this study is to determine the effect of nasal PYY3-36 on weight loss post 24 weeks of treatment.

Condition or disease	Intervention/treatment	Phase
Obesity	Drug: Nasal Placebo; Drug: Placebo Capsule; Drug: PYY3-36; Drug: Sibutramine	Phase 2

Detailed Description:

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:

• 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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 551 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A 24-Week, Blinded, Randomized, Placebo-Controlled Dose-Ranging Trial of Nasal PYY3-36 for Weight Loss in Healthy Obese Patients
• Study Start Date: October 2007
• Actual Primary Completion Date: July 2008
• Actual Study Completion Date: September 2008

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: 1; Nasal Placebo	Drug: Nasal Placebo; Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.
Placebo Comparator: 2; Capsule Placebo	Drug: Placebo Capsule; Placebo capsules will be taken once daily with or without food.
Experimental: 3; Nasal PYY3-36 200 ug	Drug: PYY3-36; Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.
Experimental: 4; Nasal PYY3-36 400 ug	Drug: PYY3-36; Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
Experimental: 5; Nasal PYY3-36 600 ug	Drug: PYY3-36; Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
Active Comparator: 6; Sibutramine 10 mg	Drug: Sibutramine; Sibutramine will be taken once daily with or without food; Other Name: Meridia

Outcome Measures

Primary Outcome Measures :

1. To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment [ Time Frame: 24 Weeks ]

Secondary Outcome Measures :

1. To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo [ Time Frame: 24 Weeks ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 65 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• Male or Female patients 18 and 65 years, inclusive;
• 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:

• Previous surgical treatment for obesity;
• 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

Contacts and Locations

Locations

United States, Arizona

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Peoria, Arizona, United States, 85381

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Phoenix, Arizona, United States, 85050

United States, California

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Anaheim, California, United States, 92801

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Beverly Hills, California, United States, 90211

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Carmichael, California, United States, 95608

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Orange, California, United States, 92869

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Sacramento, California, United States, 95816

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San Diego, California, United States, 92108

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San Diego, California, United States, 92130

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San Francisco, California, United States, 94102

United States, Florida

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Pembroke Pines, Florida, United States, 33024

United States, Georgia

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Atlanta, Georgia, United States, 30328

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Augusta, Georgia, United States, 30909

United States, Indiana

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Evansville, Indiana, United States, 47713

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Valparaiso, Indiana, United States, 46383

United States, Louisiana

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Baton Rouge, Louisiana, United States, 70808

United States, Minnesota

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Brooklyn Center, Minnesota, United States, 55430

United States, Nevada

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Las Vegas, Nevada, United States, 89104

United States, New York

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Manlius, New York, United States, 13104

United States, North Carolina

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Charlotte, North Carolina, United States, 28209

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Raleigh, North Carolina, United States, 27612

United States, Ohio

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Cleveland, Ohio, United States, 44122

United States, Pennsylvania

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Reading, Pennsylvania, United States, 19606

United States, South Carolina

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Greer, South Carolina, United States, 29651

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Mt. Pleasant, South Carolina, United States, 29464

United States, Texas

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Austin, Texas, United States, 78705

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San Antonio, Texas, United States, 78229-3894

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Temple, Texas, United States, 76508

United States, Utah

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Salt Lake City, Utah, United States, 84049

Sponsors and Collaborators

Nastech Pharmaceutical Company, Inc.

Investigators

• Study Director: Gordon Brandt, M.D.; Nastech Pharmaceutical Company, Inc.

More Information

• Responsible Party: Gordon Brandt, M.D. / President, Nastech Pharmaceutical Company, Inc.
• ClinicalTrials.gov Identifier: NCT00537420
• Other Study ID Numbers: C07-002
• First Posted: October 1, 2007
• Last Update Posted: September 15, 2008
• Last Verified: September 2008

Keywords provided by Nastech Pharmaceutical Company, Inc.:

weight loss; dieting

Additional relevant MeSH terms:

Weight Loss; Body Weight Changes; Body Weight; Sibutramine; Antidepressive Agents; Psychotropic Drugs; Appetite Depressants; Anti-Obesity Agents