Status and phase
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About
Dose escalation study of GT-001
Full description
This is a dose-escalation design trial. Twelve evaluable subjects (n=12) with BMIs of 30 to 40 kg/m2 will receive a single dose of placebo followed by study drug applied directly to the surface of the tongue mucosa with a disposable pipette followed by a one-day washout. A total of seven (7) doses will escalate to a dose of 2.5 mg.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
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:
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
Primary purpose
Allocation
Interventional model
Masking
12 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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