Obesity
Conditions
Keywords
weight loss, dieting
Brief 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
Interventions
DRUGNasal Placebo
Nasal placebo, three times a day, 30 minutes before a meal for 24 weeks.
DRUGPlacebo Capsule
Placebo capsules will be taken once daily with or without food.
DRUGPYY3-36
Nasal PYY3-36, three times a day, 30 minutes before a meal for 24 weeks.
DRUGSibutramine
Sibutramine will be taken once daily with or without food
Sponsors
Nastech Pharmaceutical Company, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effect of increasing nasal PYY3 36 dosing on weight loss post 24 weeks of treatment | 24 Weeks |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the safety of three nasal PYY3 36 dose groups compared to nasal placebo | 24 Weeks |
Countries
United States
Outcome results
None listed