Intervention: Byetta
Trial phase: Phase 3
ATC code: A10BJ01
SMILES: CCC(C)C(NC(=O)C(Cc1ccccc1)NC(=O)C(CC(C)C)NC(=O)C(CCCNC(=N)N)NC(=O)C(NC(=O)C(C)NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CCSC)NC(=O)C(CCC(N)=O)NC(=O)C(CCCCN)NC(=O)C(CO)NC(=O)C(CC(C)C)NC(=O)C(CC(=O)O)NC(=O)C(CO)NC(=O)C(NC(=O)C(Cc1ccccc1)NC(=O)C(NC(=O)CNC(=O)C(CCC(=O)O)NC(=O)CNC(=O)C(N)Cc1c[nH]cn1)C(C)O)C(C)O)C(C)C)C(=O)NC(CCC(=O)O)C(=O)NC(Cc1c[nH]c2ccccc12)C(=O)NC(CC(C)C)C(=O)NC(CCCCN)C(=O)NC(CC(N)=O)C(=O)NCC(=O)NCC(=O)N1CCCC1C(=O)NC(CO)C(=O)NC(CO)C(=O)NCC(=O)NC(C)C(=O)N1CCCC1C(=O)N1CCCC1C(=O)N1CCCC1C(=O)NC(CO)C(N)=O
Sex: All
Age groups: Adult
Healthy volunteers: Accepts Healthy Volunteers
Participants at risk: 40
Group description: 10 micrograms subcutaneously twice

Byetta (exenatide): Exenatide is an injectable medication

Weight loss: Because response to weight loss
Eligibility criteria:
INCLUSION CRITERIA:
Premenopausal women and men < 55 years of age
BMI >30 kg/m(2)
Expressed desire for weight loss
Stable weight (variation < 2.3 kg within past 6 months)
Ability to provide informed consent
Ability to follow verbal and written instructions
Nonsmoker
Ability to commute to study site on a regular basis for short outpatient visits over 5 weeks
For females, use of a medically approved form of contraception. For oral contraceptives, subjects will need to be on an established dose for at least 3 months to ensure stable weight and will be asked not to switch contraceptive methods during study participation.

EXCLUSION CRITERIA:

Age < 18 years
Use of other medications to treat obesity including medications obtained over the counter or internet, orlistat (Xenical, Alli), sibutramine (Meridia), topiramate (with or without phentermine (Qsymia), phentermine (Adipex P) or lorcaserin (Belviq) within the past 6 months
History of an eating disorder including anorexia or bulimia
History of surgery for the treatment of obesity (gastric banding, gastric bypass)
Diagnosis of type 1 or type 2 diabetes mellitus according to American Diabetes Association guidelines
Previous exposure to exenatide
Uncontrolled hypertension as defined by a blood pressure of 150/90 on two or more occasions or use of antihypertensive medications which may affect energy expenditure including alpha blockers, beta blockers, angiotensin receptor blockers or inhibitors of angiotensin converting enzyme
Current use of tobacco products, marijuana, amphetamines, cocaine or intravenous drug use
Chronic ethanol use (> 3 drinks /day)
Endocrine disorders including hypo or hyperthyroidism (including subclinical disease), Cushing s disease, growth hormone deficiency or other pituitary diseases
History of pancreatitis
Personal or family history of multiple endocrine neoplasia (MEN)-2 or medullary thyroid cancer
History of unresolved gallstones
Hyperamylasemia
Fasting triglyceride level greater than or equal to 500
Gastroparesis
Inflammatory bowel disease or malabsorption disorders
Malignancy treated with chemotherapy or radiation within the past 5 years
Current clinical depression, diagnosis of psychosis or recent use of psychotropic medication
Pregnancy within past 6 months
Breastfeeding
Failure to use medically approved contraceptive methods if subject is female
Liver function abnormalities (transaminases greater than twice normal)
Renal insufficiency (creatinine clearance < 50 ml/min)
History of chronic infection including tuberculosis, coccidiomycoses, lyme disease or HIV infection
Pulmonary disorders, including chronic obstructive pulmonary disease, which would limit ability to follow the protocol (investigator judgment)
Cardiovascular disease including history of myocardial infarction, unstable angina or heart failure
Central nervous system disease, including history of cerebrovascular accidents, dementia, and neurodegenerative disorders
Weight <450 pounds (maximum weight of the DXA machine as per manufacturer s manual)
Sensitivity to exenatide or any inert components in its formulation
Sensitivity to acetaminophen
Conditions not specifically mentioned above may serve as criteria for exclusion at the discretion of the investigators