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

March 30, 2018 updated by: Gila Therapeutics, Inc.

A Dose Escalating Study to Assess the Safety and Tolerability, Pharmacokinetics and Pharmacodynamics of a Lingual Application of GT-001 in Subjects With Obesity.

Dose escalation study of GT-001

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
12

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Tustin, California, United States, 92780
        • Orange County Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Dose escalation
Single arm dose escalation.
Drug: GT-001
PK, PD Study to Determine Safety of Escalating Doses of GT-001
Other Names:
  • PYY(3-36)
  • Peptide YY (3-36)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demonstrate safe doses of PGT-001 for reduction of body weight in obese volunteers.
Time Frame: approximately two weeks
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dose-relationship of adverse events
Time Frame: approximately two weeks
Incidence, severity and dose-relationship of adverse events as well as changes in physical examinations, vital signs and/or laboratory evaluations as a measure of safety and tolerability.
approximately two weeks
Dose relationship to peak plasma concentration of GT-001
Time Frame: Approximately two weeks
Peak plasma concentration of GT-001 to assess relationship to dose of GT-001.
Approximately two weeks
Dose relationship to hunger and satiety
Time Frame: approximately two weeks
Measurement of hunger and satiety will be conducted using visual analog scores to assess a relationship to dose of GT-001
approximately two weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gila Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 16, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 9, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 2, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 001 (Marta Eliza Miller Foundation)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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