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

NCT03490786 | Completed Phase 1 FDA Drug

• 1 other identifier: 001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Dose escalation study of GT-001

Conditions

Feeding and Eating Disorders

Keywords

GT-001

Outcome Measures

Primary Outcomes (1)

• Demonstrate safe doses of PGT-001 for reduction of body weight in obese volunteers.

  Measures of the safety and tolerability of GT-001 include documentation of adverse events and changes (compared to baseline) in vital signs, physical examination, and laboratory tests.

  approximately two weeks

Secondary Outcomes (3)

• Dose-relationship of adverse events

  approximately two weeks

• Dose relationship to peak plasma concentration of GT-001

  Approximately two weeks

• Dose relationship to hunger and satiety

  approximately two weeks

Study Arms (1)

Dose escalation

EXPERIMENTAL

Single arm dose escalation.

Drug: GT-001

Interventions

GT-001 DRUG

PK, PD Study to Determine Safety of Escalating Doses of GT-001

Also known as: PYY(3-36), Peptide YY (3-36)

Dose escalation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gila Therapeutics, Inc.: lead

Study Sites (1)

Orange County Research Center

Tustin, California, 92780, United States

Location

MeSH Terms

Conditions

Feeding and Eating Disorders

Interventions

peptide YY (3-36)

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: dose escalation

Study Record Dates

• First Submitted: February 19, 2018
• First Posted: April 6, 2018
• Study Start: July 16, 2017
• Primary Completion: August 9, 2017
• Study Completion: October 2, 2017
• Last Updated: April 6, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)