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

This study has been completed.
Sponsor:
Information provided by:
Nastech Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier:
NCT00537420
First received: September 28, 2007
Last updated: September 12, 2008
Last verified: September 2008
  Purpose

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
Obesity
Drug: Nasal Placebo
Drug: Placebo Capsule
Drug: PYY3-36
Drug: Sibutramine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Nastech Pharmaceutical Company, Inc.:

Primary Outcome Measures:
  • To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment [ Time Frame: 24 Weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo [ Time Frame: 24 Weeks ] [ Designated as safety issue: Yes ]

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
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

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
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537420

  Hide Study 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, 92130
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San Diego, California, United States, 92108
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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

No publications provided

Responsible Party: Gordon Brandt, M.D. / President, Nastech Pharmaceutical Company, Inc.
ClinicalTrials.gov Identifier: NCT00537420     History of Changes
Other Study ID Numbers: C07-002
Study First Received: September 28, 2007
Last Updated: September 12, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Nastech Pharmaceutical Company, Inc.:
weight loss
dieting

Additional relevant MeSH terms:
Obesity
Weight Loss
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Body Weight Changes
Sibutramine
Appetite Depressants
Anti-Obesity Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Antidepressive Agents
Psychotropic Drugs

ClinicalTrials.gov processed this record on July 20, 2014