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NCT Number: NCT06845033

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

18 year–60 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Center for Clinical Metabolic Research

Hellerup, 2900, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LEAP2 infusion

Other

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

Placebo

Other

Placebo infusion (saline) is different from the LEAP2 infusion

Primary outcomes

  1. Difference in food cue reactivity between experimental days

    Time frame: time 75 - 135 minutes

    The primary endpoint is the change in BOLD signals when viewing pictures of food vs. non-food. Differences will be compared between the two experimental days with infusion of placebo and LEAP2, respectively.

Secondary outcomes

  1. Difference in appetite ratings

    Time frame: From baseline to end of infusion

    Difference in visual Analogue Scales (VASs) assessing appetite, satiety, and hunger sensations.

  2. Changes in peptide hormone concentrations

    Time frame: From baseline to end of infusion

    Plasma/serum concentrations of LEAP2, growth hormone as well as other glucose- and appetite-regulating gut hormones

Other outcomes

  1. Reactivity from Negative Emoition Reactivity Test (NERT)

    Time frame: time 75 - 135 minutes

    Change in BOLD signals when viewing pictures of that could cause stress (Negative Emoition Reactivity Test (NERT)). Differences will be compared between the two experimental days with infusion of placebo and LEAP2, respectively.

  2. Plasma glucose

    Time frame: Through experimental day. From timepoints -15 to 135 min

    Change in plasma glucose concentration during the experimental days

Sponsors and collaborators

Lead sponsor

University Hospital, Gentofte, Copenhagen

Other

Registry information

Acronym: LEAP2fMRI

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Feb 25, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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