Clinical trial NCT00537420: A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese Subjects
Official title: A 24-Week, Blinded, Randomized, Placebo-Controlled Dose-Ranging Trial of Nasal PYY3-36 for Weight Loss in Healthy Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Obesity
Keywords: weight loss
dieting
Lead sponsor: Nastech Pharmaceutical Company, Inc.
Sponsor class: INDUSTRY
First posted: 2007-10-01
Enrollment: 551
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment
timeFrame: 24 Weeks
Secondary outcomes:
measure: To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo
timeFrame: 24 Weeks
Other outcomes:
Locations:
city: Peoria
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Arizona
city: Phoenix
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Arizona
city: Anaheim
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: California
city: Beverly Hills
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: California
city: Carmichael
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: California
city: Orange
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: California
city: Sacramento
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: California
city: San Diego
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: California
city: San Diego
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: California
city: San Francisco
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: California
city: Pembroke Pines
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Florida
city: Atlanta
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Georgia
city: Augusta
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Georgia
city: Evansville
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Indiana
city: Valparaiso
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Indiana
city: Baton Rouge
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Louisiana
city: Brooklyn Center
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Minnesota
city: Las Vegas
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Nevada
city: Manlius
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: New York
city: Charlotte
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: North Carolina
city: Raleigh
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: North Carolina
city: Cleveland
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Ohio
city: Reading
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Pennsylvania
city: Greer
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: South Carolina
city: Mt. Pleasant
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: South Carolina
city: Austin
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Texas
city: San Antonio
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Texas
city: Temple
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Texas
city: Salt Lake City
country: United States
facility: For additional information regarding investigative sites for this trial, contact 1-425-415-3011
state: Utah
Study officials:
affiliation: Nastech Pharmaceutical Company, Inc.
name: Gordon Brandt, M.D.
role: STUDY_DIRECTOR
References: