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

NCT ID: NCT06845033

Last Updated: 2025-04-17

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-11-01

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity and Overweight

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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LEAP2 infusion

Group Type ACTIVE_COMPARATOR

LEAP2 infusion

Intervention Type OTHER

The LEAP2 infusion is a hormone infusion that is different from the placebo (saline) infusion

Placebo infusion

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Intervention Type OTHER

Placebo

Placebo infusion (saline) is different from the LEAP2 infusion

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Anders Englund

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Anders Englund

Role: CONTACT

004556650819

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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