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

Gila Therapeutics

Status and phase

Completed

Phase 1

Conditions

Feeding and Eating Disorders

Treatments

Drug: GT-001

Study type

Interventional

Funder types

Industry

Identifiers

NCT03490786

001

Details and patient eligibility

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

12 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Adult participants with obesity class I and II (BMI 30-40 kg/m2)
Willing and able to provide written informed consent after reviewing the design and risks of the study and prior to completing any study-related procedure
Willing and able to understand and comply with all study procedures and requirements.
Women must have a predictable menstrual cycle and taking either monophasic oral contraceptives, or transdermal (Ortho Evra and Evra) at least one month prior to the study.
Alternatively, post-menopausal women (defined as period of spontaneous amenorrhea for more than 1 year), and bilateral oophorectomized women are allowed into the study.
Must be able to complete the Weight Efficacy Life-Style Questionnaire (WEL).
Systolic blood pressure 100-160 mmHg at the time of screening.
Stable and compliant treatment with oral medications for at least 4 weeks prior to screening.
Women of child bearing potential (WOCBP) and males must agree to use at least two forms of contraception, of which one includes a barrier method (male condom) by the male partner, during study participation and continued for at least 90 days after the conclusion of the final dose.
In addition, sperm donations by male subjects are not permitted during the subject's participation in the research study and for at least 90 days after the conclusion of the final dose. This criterion may be waived for male subjects who have undergone a vasectomy at least 6 months prior to screening.
Willing and able to abstain from drugs, , and tobacco during study participation.
Must have abstained from alcohol use for 48 hours prior to study day 1 through the duration of the study
Must have abstained from 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 prior to study day 1.
History of stable weight for at least 3 months prior to study entry.

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