Effects of Antagonizing the Ghrelin Receptor on Brain Food Cue Reactivity in Obesity
NCT ID: NCT06845033
Last Updated: 2025-04-17
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
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NOT_YET_RECRUITING
NA
28 participants
INTERVENTIONAL
2025-05-01
2027-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
DOUBLE
Study Groups
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LEAP2 infusion
LEAP2 infusion
The LEAP2 infusion is a hormone infusion that is different from the placebo (saline) infusion
Placebo infusion
Placebo
Placebo infusion (saline) is different from the LEAP2 infusion
Interventions
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LEAP2 infusion
The LEAP2 infusion is a hormone infusion that is different from the placebo (saline) infusion
Placebo
Placebo infusion (saline) is different from the LEAP2 infusion
Eligibility Criteria
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Inclusion Criteria
* Body mass index 30-50 kg/m2
* Men
* Informed consent
Exclusion Criteria
* 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
18 Years
60 Years
MALE
No
Sponsors
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University Hospital, Gentofte, Copenhagen
OTHER
Responsible Party
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Anders Englund
Principal Investigator
Central Contacts
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Other Identifiers
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NNF23OC0084114
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
H-2306418
Identifier Type: -
Identifier Source: org_study_id
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