Obesity and OverweightLEAP2fMRINCT06845033
Effects of Antagonizing the Ghrelin Receptor on Brain Food Cue Reactivity in Obesity
A study testing LEAP2 infusion in people with Obesity and Overweight, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men only
- Conditions the study is for
- Obesity and Overweight
- What is being tested?
- LEAP2 infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteDenmark
- Study dates
- 1 May 2025to 1 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years at the time of inclusion
- Body mass index 30-50 kg/m2
- Men
- Informed consent
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Obesity and Overweight
- Being tested
- LEAP2 infusion, Placebo
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LEAP2 infusionOther
The LEAP2 infusion is a hormone infusion that is different from the placebo (saline) infusion
PlaceboOther
Placebo infusion (saline) is different from the LEAP2 infusion
| Study group | Role | What they receive |
|---|---|---|
| LEAP2 infusion | Active comparator | Not described Receives: Other: LEAP2 infusion |
| Placebo infusion | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in food cue reactivity between experimental days
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.
Measured: time 75 - 135 minutes
Secondary outcomes (2)
Difference in appetite ratings
Difference in visual Analogue Scales (VASs) assessing appetite, satiety, and hunger sensations.
Measured: From baseline to end of infusion
Changes in peptide hormone concentrations
Plasma/serum concentrations of LEAP2, growth hormone as well as other glucose- and appetite-regulating gut hormones
Measured: From baseline to end of infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start1 May 2025
- Primary completion3 Mar 2026
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Englund, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06845033
- Sponsor's protocol ID
- H-2306418
- Other IDs
- NNF23OC0084114
- Acronym
- LEAP2fMRI
- Status last verified
- Apr 2026
- First submitted
- 7 Feb 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antagonizing the Ghrelin Receptor on Brain Food Cue Reactivity in Obesity
- ClinicalTrials.gov ID
- NCT06845033
- Acronym / sponsor ID
- LEAP2fMRI / H-2306418
- Conditions
- Obesity and Overweight
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 25 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LEAP2 infusion | Active comparator | Other: LEAP2 infusion |
| Placebo infusion | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 18 and 60 years at the time of inclusion
- Body mass index 30-50 kg/m2
- Men
- Informed consent
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LEAP2 infusionThe LEAP2 infusion is a hormone infusion that is different from the placebo (saline) infusion | Other | LEAP2 infusion |
| PlaceboPlacebo infusion (saline) is different from the LEAP2 infusion | Other | Placebo infusion |
Primary outcome
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.
2 secondary outcomes
Difference in appetite ratings
Time frame: From baseline to end of infusion
Changes in peptide hormone concentrations
Time frame: From baseline to end of infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LEAP2 infusion in people with Obesity and Overweight, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in food cue reactivity between experimental days (time frame: time 75 - 135 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.