APPETITE: linguAl PYY3-36 on aPpEtite and acuTe Energy InTakE

NCT05110664 | Unknown DMC FDA Drug

• 1 other identifier: 142589
• Study Type: observational
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Obesity

Keywords

obesity; appetite

Outcome Measures

Primary Outcomes (2)

• appetite scores

  area-under-the curve for appetite scores. Not indicative of either bad or worse outcome, just subjective indication.

  up to 6 hours

• energy intake expressed as Kcal of eaten food

  ad libitum energy intake

  up to 6 hours

Secondary Outcomes (7)

• PYY levels

  up to 6 hours

• gut hormones levels

  up to 6 hours

• 24-h energy intake

  24 hours after study visit

• 24h appetite

  24 hours after study visit

• macronutrient selection

  up to 1 hour

Study Arms (2)

Cohort/Intervention 1

Meal test

Drug: PYY (3-36) Peptide; Drug: Placibo

Cohort/Intervention 2

Ad libitum meal

Drug: PYY (3-36) Peptide; Drug: Placibo

Interventions

PYY (3-36) Peptide DRUG

oral PYY3-36 solution

Cohort/Intervention 1; Cohort/Intervention 2

Placibo DRUG

oral placebo solution

Cohort/Intervention 1; Cohort/Intervention 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• \. 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).
• \. 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.
• \. 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• University College, London: lead
• Gila Therapeutics, Inc.: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and saliva

MeSH Terms

Conditions

Obesity

Interventions

peptide YY (3-36)

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rachel L Batterham

CONTACT

02076790991; r.batterham@ucl.ac.uk

Alisia Carnemolla, PhD

CONTACT

02076796308; a.carnemolla@ucl.ac.uk

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: November 8, 2021
• Study Start: February 1, 2022
• Primary Completion: August 1, 2022
• Study Completion: October 1, 2022
• Last Updated: November 8, 2021

Record last verified: 2021-09