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

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

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study

Study Primary Completion Date: July 2008

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

Intervention(s) in this Clinical Trial

• 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

Arms, Groups and Cohorts in this Clinical Trial

• Placebo Comparator: 1
  • Nasal Placebo
• Placebo Comparator: 2
  • Capsule Placebo
• Experimental: 3
  • Nasal PYY3-36 200 ug
• Experimental: 4
  • Nasal PYY3-36 400 ug
• Experimental: 5
  • Nasal PYY3-36 600 ug
• Active Comparator: 6
  • Sibutramine 10 mg

Primary Measures

• To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment
  • Time Frame: 24 Weeks
    Safety Issue?: No

Secondary Measures

• To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo
  • Time Frame: 24 Weeks
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Nastech Pharmaceutical Company, Inc.

Overall Clinical Trial Officials and Contacts

Gordon Brandt, M.D. Study Director Nastech Pharmaceutical Company, Inc.  

Information obtained from ClinicalTrials.gov on August 28, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00537420

Study ID Number: C07-002

ClinicalTrials.gov Identifier: NCT00537420

Health Authority: United States: Food and Drug Administration