Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2026-02-22 @ 9:00 AM
Study NCT ID:
NCT00537420
Status:
COMPLETED
Last Update Posted:
2008-09-15
First Post:
2007-09-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Nasal PYY3-36 and Placebo for Weight Loss in Obese Subjects
Sponsor:
Nastech Pharmaceutical Company, Inc.
Organization:
Study Overview
Official Title:
A 24-Week, Blinded, Randomized, Placebo-Controlled Dose-Ranging Trial of Nasal PYY3-36 for Weight Loss in Healthy Obese Patients
Status:
COMPLETED
Status Verified Date:
2008-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: