ObesityAPPETITENCT05110664
APPETITE: linguAl PYY3-36 on aPpEtite and acuTe Energy InTakE
An observational study of Obesity, run by University College, London.
Trial summary
A double-blind, cross-over, placebo-controlled, proof-of-concept study using oral peptide YY3-36 solution to investigate the mechanistic role of lingual PYY in regulating appetite, energy intake and food preference in people with overweight/obesity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- PYY (3-36) Peptide and Placibo
- Type of treatment
- Pill or oral medicine
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2022to Oct 2022
- Phase
- Observational
- 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 to 65 years
- All sexes
- Adult, Older adult
Study population: 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.
Who may be able to join
- 1. Adults aged 18-65 inclusive. 2. People with a body mass index (BMI) between 25.0 and 39.9 kg/m2 3. Stable weight for past 3 months (≤5% change in preceding 3 months as reported by participants).
- 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.
Who cannot join
- Female subjects who are pregnant or breast-feeding.
- Female subjects of childbearing potential who are not on highly effective contraception.
- Post-menopausal women who have not had a period of spontaneous amenorrhea for more than 1 year.
- Previous bariatric surgery.
- Type 1 or 2 diabetes.
- Current use of weight loss medications or taking medication that affects appetite, e.g., antidepressants such as mirtazapine.
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- Food intolerances, or allergies, that would make fixed energy meal and/or ad libitum meal unable to be performed.
- Impairment of sense of taste and/or smell, as per subject assessment and direct questioning.
- Poor dental hygiene or oral pathology.
- Current smokers of tobacco products.
- Any other factor making the participant unsuitable in the view of investigator.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Double-blind, Cross-over, Placebo-controlled, Proof-of-concept Study Using Oral Peptide YY3-36 Solution to Investigate the Mechanistic Role of Lingual PYY in Regulating Appetite, Energy Intake and Food Preference in People With Overweight/Obesity
A double-blind, cross-over, placebo-controlled, proof-of-concept study using oral peptide YY3-36 solution to investigate the mechanistic role of lingual PYY in regulating appetite, energy intake and food preference in people with overweight/obesity. The aim of this study is to investigate the mechanistic role of lingual PYY in regulating appetite, energy intake and food preference in people with overweight/obesity.
Read the detailed description
In order to address the study objective two independent investigations in two separate groups of participants will need to be undertaken, to avoid cross-contamination of the results.
- 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.
- 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
- Obesity
- Being tested
- PYY (3-36) Peptide, Placibo
- Keywords
- obesity, appetite
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PYY (3-36) PeptideDrug
oral PYY3-36 solution
PlaciboDrug
oral placebo solution
| Study group | Role | What they receive |
|---|---|---|
| Cohort/Intervention 1 | Meal test Receives: Drug: PYY (3-36) Peptide; Drug: Placibo | |
| Cohort/Intervention 2 | Ad libitum meal Receives: Drug: PYY (3-36) Peptide; Drug: Placibo |
What is being measured
The primary outcome is the main question the study is designed to answer.
appetite scores
area-under-the curve for appetite scores. Not indicative of either bad or worse outcome, just subjective indication.
Measured: up to 6 hours
energy intake expressed as Kcal of eaten food
ad libitum energy intake
Measured: up to 6 hours
Secondary outcomes (7)
PYY levels
Area-under-the-curve for saliva PYY levels
Measured: up to 6 hours
gut hormones levels
Area-under-the-curve for gut hormones levels
Measured: up to 6 hours
24-h energy intake
Measured: 24 hours after study visit
24h appetite
Subjective appetite scores for 24 hours following a fixed meal using VAS - a 1 to 10 scale will be used where the higher the score the higher the level of feeling of the item for the subject. No better or worse meaning applied a priory.
Measured: 24 hours after study visit
macronutrient selection
Macronutrient content of consumed food during ad libitum meal
Measured: up to 1 hour
food preference using labelled magnitude scales (LMS)
labelled magnitude scales (LMS) for components of the ad libitum meal
Measured: through study completion, an average of 6 hours
food preference questionnaire (FPQ)
The food preference questionnaire requires participants to rate their liking of 62 individual foods on a 5-point Likert scale, ranging from "not at all" to "a lot". A higher score indicative of greater liking of a food.
Measured: once, at beginning of study visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study startFeb 2022 (estimated)
- Primary completionAug 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Gila Therapeutics, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05110664
- Sponsor's protocol ID
- 142589
- Acronym
- APPETITE
- Status last verified
- Sep 2021
- First submitted
- 24 Sep 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind, Cross-over, Placebo-controlled, Proof-of-concept Study Using Oral Peptide YY3-36 Solution to Investigate the Mechanistic Role of Lingual PYY in Regulating Appetite, Energy Intake and Food Preference in People With Overweight/Obesity
- ClinicalTrials.gov ID
- NCT05110664
- Acronym / sponsor ID
- APPETITE / 142589
- Conditions
- Obesity
- Keywords
- obesity, appetite
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Gila Therapeutics, Inc.
- Study start
- Feb 2022 (estimated)
- Primary completion
- Aug 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A double-blind, cross-over, placebo-controlled, proof-of-concept study using oral peptide YY3-36 solution to investigate the mechanistic role of lingual PYY in regulating appetite, energy intake and food preference in people with overweight/obesity. The aim of this study is to investigate the mechanistic role of lingual PYY in regulating appetite, energy intake and food preference in people with overweight/obesity.
Detailed description
In order to address the study objective two independent investigations in two separate groups of participants will need to be undertaken, to avoid cross-contamination of the results.
- 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.
- 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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort/Intervention 1 | – | Drug: PYY (3-36) Peptide, Drug: PlaciboMeal test |
| Cohort/Intervention 2 | – | Drug: PYY (3-36) Peptide, Drug: PlaciboAd libitum meal |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (3 listed)
- 1. Adults aged 18-65 inclusive. 2. People with a body mass index (BMI) between 25.0 and 39.9 kg/m2 3. Stable weight for past 3 months (≤5% change in preceding 3 months as reported by participants).
- 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.
Key exclusion criteria (11 listed)
- Female subjects who are pregnant or breast-feeding.
- Female subjects of childbearing potential who are not on highly effective contraception.
- Post-menopausal women who have not had a period of spontaneous amenorrhea for more than 1 year.
- Previous bariatric surgery.
- Type 1 or 2 diabetes.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PYY (3-36) Peptideoral PYY3-36 solution | Drug | Cohort/Intervention 1, Cohort/Intervention 2 |
| Placibooral placebo solution | Drug | Cohort/Intervention 1, Cohort/Intervention 2 |
Primary outcome
appetite scores
Time frame: up to 6 hours
area-under-the curve for appetite scores. Not indicative of either bad or worse outcome, just subjective indication.
energy intake expressed as Kcal of eaten food
Time frame: up to 6 hours
ad libitum energy intake
7 secondary outcomes
PYY levels
Time frame: up to 6 hours
gut hormones levels
Time frame: up to 6 hours
24-h energy intake
Time frame: 24 hours after study visit
24h appetite
Time frame: 24 hours after study visit
macronutrient selection
Time frame: up to 1 hour
food preference using labelled magnitude scales (LMS)
Time frame: through study completion, an average of 6 hours
food preference questionnaire (FPQ)
Time frame: once, at beginning of study visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University College, London.
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 3 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rachel L Batterham (02076790991 ext. 40991, r.batterham@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
appetite scores (time frame: up to 6 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2021.