A Dose Escalating Study to Assess the Safety and Tolerability of GT-001

Exclusion Criteria

• •Known hypersensitivity or allergy to Peptide YY, Pancreatic polypeptide (PP), other similar polypeptides or related compounds
• •Known mutation to PYY or Y2 receptor gene (i.e., Pima Indians)
• •Any medical condition for which modification of the medication that cannot be performed either safely or feasibly. Chronic diseases including metabolic, psychiatric, cardiovascular, endocrine, etc. for which the participant is not stable for 60 days prior to study initiation
• •Female subjects who are pregnant or breast-feeding
• •Female subjects of child bearing potential who are not on oral contraceptives or using biphasic or triphasic oral contraceptives
• •Post-menopausal women who have not had a period of spontaneous amenorrhea for more than 1 year Unstable psychological or behavior profile (e.g., anxiety, depression)
• •Subjects with fasting glucose levels greater than 125 mg/dl.
• •Type I or Type II diabetes
• •Poor dentition or oral pathology
• •Unable or unwilling to give written informed consent.
• •Temperature \> 38°C (oral or equivalent)
• •Sepsis or active infection requiring IV antimicrobial treatment
• •Acute myocarditis or hypertrophic obstructive, restrictive, or constrictive cardiomyopathy (not including restrictive mitral filling patterns)
• •Major neurologic event, including cerebrovascular events within 60 days prior to study initiation
• •Significant pulmonary disease (e.g., history of oral daily steroid dependency, history of CO2 retention or need for intubation for acute exacerbation, or currently receiving IV steroids)
• •Known hepatic impairment as indicated by any of the following:
• •* Total bilirubin \> 3 mg/dl
• •* Albumin \< 2.8 mg/dl, with other signs or symptoms of hepatic dysfunction
• •* Increased ammonia levels, if performed, with other signs or symptoms of hepatic dysfunction
• •Any organ transplant recipient or currently listed (anticipated in the next 60 days) for transplant
• •Major surgery within 30 days prior to study initiation
• •Positive screen for Hepatitis B (HbsAg, Hepatitis B Surface Antigen), Hepatitis C (anti-HCV, Hepatitis C Antibody), or HIV (anti-HIV 1/2)
• •Received an investigational intervention within 30 days prior to study initiation, or have received PYY3-36, GLP-1 agonists, insulin or DPP-IV inhibitors in a previous clinical trial.
• •Consumption of alcohol within 48 hours prior to study day1 and through study day 15 or early termination
• •Use of any tobacco- or nicotine-containing products (e.g., cigarettes, e-cigarettes, pipes, cigars, chewing tobacco, nicotine patches, nicotine lozenges, or nicotine gum) within 6 months
• •A positive urine drug screen for ethanol, cotinine, cocaine, THC, barbiturates, amphetamines, benzodiazepines, and/or opiates
• •A history of difficulty with donating blood, or having donated blood or blood products within 45 days prior to study initiation
• •Use of weight loss drugs Orlistat (Alli or Xenical), Qsymia, Phentermine, Contrave, Lorcaserin, liraglutide, topiramate or exenatide within the last six months.
• •Concurrent use of antihistamines
• •Any condition that, in the opinion of the Investigator or Medical Monitor, would render the subject unsuitable for participation in the study
• •Unable to consume the test meal