Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-03-09 @ 7:50 AM
Study NCT ID:
NCT06845033
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-17
First Post:
2025-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Antagonizing the Ghrelin Receptor on Brain Food Cue Reactivity in Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 28}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2027-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2025-02-07', 'studyFirstSubmitQcDate': '2025-02-21', 'lastUpdatePostDateStruct': {'date': '2025-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Reactivity from Negative Emoition Reactivity Test (NERT)', 'timeFrame': 'time 75 - 135 minutes', 'description': '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.'}, {'measure': 'Plasma glucose', 'timeFrame': 'Through experimental day. From timepoints -15 to 135 min', 'description': 'Change in plasma glucose concentration during the experimental days'}], 'primaryOutcomes': [{'measure': 'Difference in food cue reactivity between experimental days', 'timeFrame': 'time 75 - 135 minutes', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Difference in appetite ratings', 'timeFrame': 'From baseline to end of infusion', 'description': 'Difference in visual Analogue Scales (VASs) assessing appetite, satiety, and hunger sensations.'}, {'measure': 'Changes in peptide hormone concentrations', 'timeFrame': 'From baseline to end of infusion', 'description': 'Plasma/serum concentrations of LEAP2, growth hormone as well as other glucose- and appetite-regulating gut hormones'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity and Overweight']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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.\n\nParticipants 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.\n\nThe study will attribute to gain a deeper understanding of the ghrelin system and its interaction with appetite regulation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 18 and 60 years at the time of inclusion\n* Body mass index 30-50 kg/m2\n* Men\n* Informed consent\n\nExclusion Criteria:\n\n* Anaemia (haemoglobin below normal range)\n* Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) \\>2 times normal values) or present hepatobiliary and/or gastrointestinal disorder(s)\n* Nephropathy (serum creatinine above normal range and/or albuminuria)\n* Glycated haemoglobin (HbA1c) ≥48 mmol/mol and/or type 2 diabetes requiring medical treatment\n* Regular tobacco smoking or use of other nicotine-containing products\n* Claustrophobia\n* Any ongoing medication that the investigator evaluates would interfere with trial participation.\n* Any physical or psychological condition that the investigator evaluates would interfere with trial participation including any acute or chronic illnesses'}, 'identificationModule': {'nctId': 'NCT06845033', 'acronym': 'LEAP2fMRI', 'briefTitle': 'Effects of Antagonizing the Ghrelin Receptor on Brain Food Cue Reactivity in Obesity', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Effects of Antagonizing the Ghrelin Receptor on Brain Food Cue Reactivity in Obesity', 'orgStudyIdInfo': {'id': 'H-2306418'}, 'secondaryIdInfos': [{'id': 'NNF23OC0084114', 'type': 'OTHER_GRANT', 'domain': 'Novo Nordisk Foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'LEAP2 infusion', 'interventionNames': ['Other: LEAP2 infusion']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo infusion', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'LEAP2 infusion', 'type': 'OTHER', 'description': 'The LEAP2 infusion is a hormone infusion that is different from the placebo (saline) infusion', 'armGroupLabels': ['LEAP2 infusion']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo infusion (saline) is different from the LEAP2 infusion', 'armGroupLabels': ['Placebo infusion']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Anders Englund', 'role': 'CONTACT', 'email': 'anders.englund@regionh.dk', 'phone': '004556650819'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Anders Englund', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}