NCT00537420

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 551 (actual)
• Sponsor: Nastech Pharmaceutical Company, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	Nasal Placebo	Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.
DRUG	Placebo Capsule	Placebo capsules will be taken once daily with or without food.
DRUG	PYY3-36	Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.
DRUG	PYY3-36	Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
DRUG	PYY3-36	Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.
DRUG	Sibutramine	Sibutramine will be taken once daily with or without food

Timeline

• Start date: 2007-10-01
• Primary completion: 2008-07-01
• Completion: 2008-09-01
• First posted: 2007-10-01
• Last updated: 2008-09-15

Locations

29 sites across 1 country: United States