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

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

Detailed Description
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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

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

Conditions
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Obesity

Intervention / Treatment
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* Drug: Nasal Placebo
* Drug: Placebo Capsule
* Drug: PYY3-36
* Drug: PYY3-36
* Drug: PYY3-36
* Drug: Sibutramine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Nasal Placebo | Drug: Nasal Placebo<br>* Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.<br>|
| Placebo Comparator: 2<br>Capsule Placebo | Drug: Placebo Capsule<br>* Placebo capsules will be taken once daily with or without food.<br>|
| Experimental: 3<br>Nasal PYY3-36 200 ug | Drug: PYY3-36<br>* Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.<br>|
| Experimental: 4<br>Nasal PYY3-36 400 ug | Drug: PYY3-36<br>* Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.<br>|
| Experimental: 5<br>Nasal PYY3-36 600 ug | Drug: PYY3-36<br>* Nasal PYY3-36 three times a day, 30 minutes before a meal for 24 weeks.<br>|
| Active Comparator: 6<br>Sibutramine 10 mg | Drug: Sibutramine<br>* Sibutramine will be taken once daily with or without food<br>* Other names: Meridia;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment |  | 24 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo |  | 24 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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weight loss, dieting