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

Obesity Clinical Trial

Official title:

A 24-Week, Blinded, Randomized, Placebo-Controlled Dose-Ranging Trial of Nasal PYY3-36 for Weight Loss in Healthy Obese Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537420
• Other study ID #: C07-002
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2007
• Last updated: September 12, 2008
• Start date: October 2007
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Nastech Pharmaceutical Company, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 551
• Est. completion date: September 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity
• Weight Loss

Intervention

Drug:
• 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

Locations

Country	Name	City	State
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Anaheim	California
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Atlanta	Georgia
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Augusta	Georgia
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Austin	Texas
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Baton Rouge	Louisiana
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Beverly Hills	California
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Brooklyn Center	Minnesota
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Carmichael	California
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Charlotte	North Carolina
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Cleveland	Ohio
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Evansville	Indiana
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Greer	South Carolina
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Las Vegas	Nevada
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Manlius	New York
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Mt. Pleasant	South Carolina
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Orange	California
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Pembroke Pines	Florida
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Peoria	Arizona
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Phoenix	Arizona
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Raleigh	North Carolina
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Reading	Pennsylvania
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Sacramento	California
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Salt Lake City	Utah
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	San Antonio	Texas
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	San Diego	California
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	San Diego	California
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	San Francisco	California
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Temple	Texas
United States	For additional information regarding investigative sites for this trial, contact 1-425-415-3011	Valparaiso	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Nastech Pharmaceutical Company, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment		24 Weeks	No
Secondary	To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo		24 Weeks	Yes