A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese Subjects
Information source: Nastech Pharmaceutical Company, Inc.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Obesity
Intervention: Nasal Placebo (Drug); Placebo Capsule (Drug); PYY3-36 (Drug); PYY3-36 (Drug); PYY3-36 (Drug); Sibutramine (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: Nastech Pharmaceutical Company, Inc. Official(s) and/or principal investigator(s): Gordon Brandt, M.D., Study Director, Affiliation: Nastech Pharmaceutical Company, Inc.
Summary
The purpose of this study is to determine the effect of nasal PYY3-36 on weight loss post 24
weeks of treatment.
Clinical Details
Official title: A 24-Week, Blinded, Randomized, Placebo-Controlled Dose-Ranging Trial of Nasal PYY3-36 for Weight Loss in Healthy Obese Patients
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment
Secondary outcome: To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo
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
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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
Locations and Contacts
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Peoria, Arizona 85381, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Phoenix, Arizona 85050, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Anaheim, California 92801, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Beverly Hills, California 90211, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Carmichael, California 95608, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Orange, California 92869, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Sacramento, California 95816, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, San Diego, California 92130, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, San Diego, California 92108, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, San Francisco, California 94102, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Pembroke Pines, Florida 33024, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Atlanta, Georgia 30328, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Augusta, Georgia 30909, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Evansville, Indiana 47713, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Valparaiso, Indiana 46383, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Baton Rouge, Louisiana 70808, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Brooklyn Center, Minnesota 55430, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Las Vegas, Nevada 89104, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Manlius, New York 13104, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Charlotte, North Carolina 28209, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Raleigh, North Carolina 27612, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Cleveland, Ohio 44122, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Reading, Pennsylvania 19606, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Greer, South Carolina 29651, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Mt. Pleasant, South Carolina 29464, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Austin, Texas 78705, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, San Antonio, Texas 78229-3894, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Temple, Texas 76508, United States
For additional information regarding investigative sites for this trial, contact 1-425-415-3011, Salt Lake City, Utah 84049, United States
Additional Information
Starting date: October 2007
Last updated: September 12, 2008
|