Effects of Antagonizing the Ghrelin Receptor on Brain Food Cue Reactivity in Obesity (LEAP2fMRI)

University Hospital, Gentofte, Copenhagen

Status: Not yet enrolling

Conditions: Obesity and Overweight

Treatments: Other: Placebo; Other: LEAP2 infusion

Study type: Interventional

Funder types: Other

Identifiers

NCT06845033

H-2306418

NNF23OC0084114 (Other Grant/Funding Number)

Details and patient eligibility

About

The naturally occurring peptide hormone liver-expressed antimicrobial peptide 2 (LEAP2) in an antagonist/inverse agonist towards the ghrelin receptor. Ghrelin administration has previously been shown to increase food cue reactivity in brain regions related to appetite and reward using functional MRI scans.

The aim of this clinical study is to investigate the effects of LEAP2 infusion on food cue reactivity in brain regions related to appetite and reward. Since LEAP2 is an antagonist/inverse agonist towards the ghrelin receptor we hypothesize, that LEAP2 infusion will decrease food cue reactivity in the above-mentioned regions compared to placebo infusion.

Participants with obesity (BMI 30-50 kg/m2) will be included and complete two experimental days with either LEAP2 or placebo infusion in a randomized crossover manner. On experimental days, participants will undergo a MRI scan with functional and anatomical modalities.

The study will attribute to gain a deeper understanding of the ghrelin system and its interaction with appetite regulation.

Enrollment: 28 estimated patients

Sex: Male

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age between 18 and 60 years at the time of inclusion
• Body mass index 30-50 kg/m2
• Men
• Informed consent

Exclusion criteria

• Anaemia (haemoglobin below normal range)
• Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) >2 times normal values) or present hepatobiliary and/or gastrointestinal disorder(s)
• Nephropathy (serum creatinine above normal range and/or albuminuria)
• Glycated haemoglobin (HbA1c) ≥48 mmol/mol and/or type 2 diabetes requiring medical treatment
• Regular tobacco smoking or use of other nicotine-containing products
• Claustrophobia
• Any ongoing medication that the investigator evaluates would interfere with trial participation.
• Any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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28 participants in 2 patient groups, including a placebo group

LEAP2 infusion

Active Comparator group

Treatment:

Other: LEAP2 infusion

Placebo infusion

Placebo Comparator group

Treatment:

Other: Placebo