APPETITE: linguAl PYY3-36 on aPpEtite and acuTe Energy InTakE
NCT ID: NCT05110664
Last Updated: 2021-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
40 participants
OBSERVATIONAL
2022-02-28
2022-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
1. Cohort/Investigation 1: A randomised within-subject double-blind cross-over placebo-controlled study to investigate the role of lingual PYY in regulating fasted and post-meal appetite following a fixed energy intake meal.
2. Cohort/Investigation 2: A randomised within-subject double-blind cross-over placebo-controlled study to investigate the role of lingual PYY in regulating ad libitum energy intake and food preference.
People with overweight or obesity (BMI 25.0-39.9 kg/m2), identified via the University College London Hospitals (UCLH) Bariatric Centre for Weight Management and Metabolic Surgery and through advertising via University College London (UCL) and ULCH, will be invited to take part.
Potential participants will initially attend a screening visit, where informed, written consent will first be taken. During the screening visit, medical, drug and dietary histories will be taken and participant eligibility will be confirmed.
Participants will attend on two separate occasions at least 7 days apart for both cohort/investigation 1 and cohort/investigation 2. 20 participants per cohort/investigation will be randomised (in a 1:1 manner), stratified by sex, to receive either oral PYY3-36 solution or matched placebo at their first study visit. Participants will be recruited onto study/investigation 1 first and once this is complete, new subjects will be enrolled onto study/investigation 2.
Cohort/Intervention 1: The day prior to each visit participants will complete a 24 hour food diary and appetite scores at home. Participants will fast overnight (12 hours) and consume only water until reaching the clinical facility the following morning. Participants will need to refrain from exercise for 2 days prior to the study visits and from drinking alcohol. On arrival, medical history will be re-reviewed, sociodemographic information collected and a pregnancy test for women of childbearing potential will be performed. Body weight and composition will be measured. Baseline assessments of fasted subjective appetite assessed using validated visual analogue scales (VAS), saliva PYY levels (via saliva sample) and circulating gut hormones (via blood sample) will be taken.
A single dose of lingual PYY (GT-001) or placebo will be administered. Appetite scores and a paired blood and saliva sample will be collected 10-15 minutes later. 30 minutes after study drug application, participants will then be asked to consume a standardised fixed meal over 15 minutes using established protocol and appetite scores (VAS) and saliva and blood samples will be taken for 180 minutes post-meal at regular intervals. Participants will be asked to complete 24-hour food diary and appetite scores 6, 12 and 24 hours after the study visit.
Cohort/Intervention 2: The day prior to each study visit participants will complete a 24-hour food diary and appetite scores at home. Participants will fast overnight (12 hours) and consume only water until reaching the clinical facility the following morning. Participants will need to refrain from exercise for 2 days prior to the study visits and from drinking alcohol. On arrival, medical history will be re-reviewed, sociodemographic information collected and a pregnancy test for women of childbearing potential will be performed. Body weight and composition will be measured. Baseline assessments of fasted subjective appetite assessed using validated VAS, saliva PYY levels (via saliva sample) and circulating gut hormones (via blood sample) will be taken.
A single dose of lingual PYY (GT-001) or placebo will be administered. Appetite scores and a paired blood and saliva sample will be collected 10-15 minutes later. 30 minutes after study drug application, participants will be offered an extensive free-choice buffet lunch and asked to eat until full. Ad libitum energy intake and food preferences will be assessed. Participants will be asked to rank likeness of the items of the buffet. Appetite scores (VAS) and paired blood and saliva sample will be taken again 60 minutes from the onset of the meal. Participants will be asked to complete 24-hour food diary and appetite scores 24 hours after the study visit.
After a 7-day washout period participants in each cohort/intervention will be crossed-over and the same visit will be repeated. Both the participants and researchers will be blinded to the study condition.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
OTHER
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort/Intervention 1
Meal test
PYY (3-36) Peptide
oral PYY3-36 solution
Placibo
oral placebo solution
Cohort/Intervention 2
Ad libitum meal
PYY (3-36) Peptide
oral PYY3-36 solution
Placibo
oral placebo solution
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PYY (3-36) Peptide
oral PYY3-36 solution
Placibo
oral placebo solution
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
4\. Females of childbearing potential must be on highly effective contraception and have a negative pregnancy test within 7 days of their study visits. NOTE: Subjects are considered not of childbearing potential if they are surgically sterile (i.e. they have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are postmenopausal.
5\. Fluent in English and able to understand and complete questionnaires. 6. Willing and able to provide written informed consent and comply with the study protocol.
Exclusion Criteria
2. Female subjects of childbearing potential who are not on highly effective contraception.
3. Post-menopausal women who have not had a period of spontaneous amenorrhea for more than 1 year.
4. Previous bariatric surgery.
5. Type 1 or 2 diabetes.
6. Current use of weight loss medications or taking medication that affects appetite, e.g., antidepressants such as mirtazapine.
7. Food intolerances, or allergies, that would make fixed energy meal and/or ad libitum meal unable to be performed.
8. Impairment of sense of taste and/or smell, as per subject assessment and direct questioning.
9. Poor dental hygiene or oral pathology.
10. Current smokers of tobacco products.
11. Any other factor making the participant unsuitable in the view of investigator.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Gila Therapeutics, Inc.
INDUSTRY
University College, London
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
142589
Identifier Type: -
Identifier Source: org_study_id