Trial | NCT00537420  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    pyy 3-36 sibutramine ...

  • Study Participants

    551
The purpose of this study is to determine the effect of nasal PYY3-36 on weight loss post 24 weeks of treatment.
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
Study Started
Oct 31
2007
Primary Completion
Jul 31
2008
Study Completion
Sep 30
2008
Last Update
Sep 15
2008
Estimate

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

  • Other names: Meridia

1 Placebo Comparator

Nasal Placebo

2 Placebo Comparator

Capsule Placebo

3 Experimental

Nasal PYY3-36 200 ug

4 Experimental

Nasal PYY3-36 400 ug

5 Experimental

Nasal PYY3-36 600 ug

6 Active Comparator

Sibutramine 10 mg

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
No Results Posted