AzTrials
AzTrials

Feeding and Eating DisordersPhase 1NCT03490786

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

A Phase 1 study testing GT-001 in people with Feeding and Eating Disorders, run by Gila Therapeutics, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Dose escalation study of GT-001 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Feeding and Eating Disorders
What is being tested?
GT-001
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
16 Jul 2017to 2 Oct 2017
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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).
Show all 14Show fewer
  • 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.

Who cannot join

  • 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)
Show all 31Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Orange County Research Center

    Tustin, California, 92780

Other trials in United States

About this study

Official title: 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

Read the 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.

Being tested
GT-001
Keywords
GT-001
Medical subject headings
Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GT-001Drug

    Also called PYY(3-36), Peptide YY (3-36)

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

Study groups in NCT03490786
Study groupRoleWhat they receive
Dose escalationExperimentalSingle arm dose escalation.
Receives: Drug: GT-001

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: approximately two weeks

Secondary outcomes (3)

  1. Dose-relationship of adverse events

    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.

    Measured: approximately two weeks

  2. Dose relationship to peak plasma concentration of GT-001

    Peak plasma concentration of GT-001 to assess relationship to dose of GT-001.

    Measured: Approximately two weeks

  3. Dose relationship to hunger and satiety

    Measurement of hunger and satiety will be conducted using visual analog scores to assess a relationship to dose of GT-001

    Measured: approximately two weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2018
  2. Study start16 Jul 2017
  3. Primary completion9 Aug 2017
  4. Study completion2 Oct 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
dose escalation
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03490786
Sponsor's protocol ID
001
Status last verified
Mar 2018
First submitted
19 Feb 2018
Last updated
6 Apr 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing GT-001 in people with Feeding and Eating Disorders, run by Gila Therapeutics, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Demonstrate safe doses of PGT-001 for reduction of body weight in obese volunteers. (time frame: approximately two weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03490786.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2018.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in