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

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nastech Pharmaceutical Company, Inc.
• Treatments: Sibutramine

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