Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 3:32 AM
Study NCT ID:
NCT07411560
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or Obese
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054795', 'term': 'Incretins'}, {'id': 'C000717792', 'term': 'cagrilintide'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-09', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2027-01-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-01-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Treatment Emergent Adverse Events (TEAEs) nausea, vomiting and diarrhoea', 'timeFrame': 'From first investigational medicinal products (IMP) administration (visit 2, day 1 or visit 9, day 74) to the end of treatment visit (Visit 2, day 16 or Visit 9, day 89)', 'description': 'Measured as number of events.'}], 'secondaryOutcomes': [{'measure': 'Total number of Adverse Events', 'timeFrame': 'First IMP administration (visit 2, day 1) to the end of treatment follow up visit (visit 16, day 142)', 'description': 'Measured as number of events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Overweight', 'Obese']}, 'descriptionModule': {'briefSummary': 'This trial is being done to look at the safety and effect of combining cagrilintide and NNC0480-0389 in people living with overweight and obesity compared to taking cagrilintide alone. In one period participants will get two medicines: cagrilintide and NNC0480-0389. In the other period, participants will get cagrilintide together with a placebo version of NNC0480-0389.The placebo looks like the real treatment but does not have any active medicine in it. Cagrilintide and NNC0480-0389 is a new medicine being tested to help people with type 2 diabetes and/or overweight or obesity. The trial medicines is not yet approved for use outside of clinical trials. Participants will receive the trial medicines the way the trial doctor has described. The study will last for about 4.5 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female at birth.\n* Age 18-64 years (both inclusive) at the time of signing the informed consent.\n* Body mass index (BMI) between 27.0 kilograms per square meter (kg/m\\^2) and 39.9 kg/m\\^2 (both inclusive) at screening.\n* Overweight should be due to excess adipose tissue, as judged by the investigator.\n* Considered eligible with suitable veins for cannulation or repeated venepuncture, as judged by the investigator.\n* No clinically significant findings during medical history, physical examination, vital signs, electrocardiogram or clinical laboratory tests at the screening visit, as assessed by the investigator.\n\nExclusion Criteria:\n\n* Known or suspected hypersensitivity to study intervention(s) or related products.\n* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using highly effective contraceptive method.\n* Current participation (i.e., dosing) in any other interventional clinical study within 90 days before screening.\n* Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.\n* Treatment with any medication prescribed for the indication of obesity or weight management within 90 days before screening, including incretin-based treatment(s).\n* Previous or planned (during the study period) obesity treatment with surgery. However, the following are allowed:\n\n 1. Liposuction and/or abdominoplasty, if performed greater than symbol (\\>) 1 year before screening.\n 2. Adjustable gastric banding, if the band has been removed \\> 1 year before screening.\n 3. Intragastric balloon, if the balloon has been removed \\> 1 year before screening.\n 4. Duodenal-jejunal bypass liner (e.g., Endobarrier), if the sleeve has been removed \\> 1 year before screening."}, 'identificationModule': {'nctId': 'NCT07411560', 'briefTitle': 'A Study Looking at How Weekly Injections of Two Hormones - GIP and Amylin - Affect Stomach-related Side Effects in People Who Are Overweight or Obese', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novo Nordisk A/S'}, 'officialTitle': 'Single-centre Study Investigating the Role of Long-acting Subcutaneous Glucose-dependent Insulinotropic Polypeptide Receptor Agonist (GIP RA) in Combination With Long-acting Subcutaneous Amylin Receptor Agonist on Gastrointestinal Tolerability in Participants With Overweight or Obesity', 'orgStudyIdInfo': {'id': 'EX0700-8445'}, 'secondaryIdInfos': [{'id': 'U1111-1324-3573', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide', 'description': 'Participants will receive low dose of GIP and Cagrilintide escalated to medium dose of GIP and high dose of Cagrilintide in treatment period 1 followed by GIP Placebo along with escalating doses of Cagrilintide from low to high in treatment period 2.', 'interventionNames': ['Drug: Glucose-dependent Insulinotropic Polypeptide (GIP)', 'Drug: Cagrilintide', 'Drug: Placebo GIP']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide', 'description': 'Participants will receive GIP placebo along with escalating doses of Cagrilintide from low to high in treatment period 1 followed by low dose of GIP and Cagrilintide escalated to medium dose of GIP and high dose of Cagrilintide in treatment period 2.', 'interventionNames': ['Drug: Glucose-dependent Insulinotropic Polypeptide (GIP)', 'Drug: Cagrilintide', 'Drug: Placebo GIP']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide', 'description': 'Participants will receive high dose of GIP and low dose of Cagrilintide escalated to higher dose of GIP and high dose of Cagrilintide in treatment period 1 followed by GIP Placebo along with escalating doses of Cagrilintide from low to high in treatment period 2.', 'interventionNames': ['Drug: Glucose-dependent Insulinotropic Polypeptide (GIP)', 'Drug: Cagrilintide', 'Drug: Placebo GIP']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide', 'description': 'Participants will receive GIP placebo along with escalating doses of Cagrilintide from low to high in treatment period 1 followed by medium dose of GIP and low dose of Cagrilintide escalated to higher dose of GIP and high dose of Cagrilintide in treatment period 2.', 'interventionNames': ['Drug: Glucose-dependent Insulinotropic Polypeptide (GIP)', 'Drug: Cagrilintide', 'Drug: Placebo GIP']}], 'interventions': [{'name': 'Glucose-dependent Insulinotropic Polypeptide (GIP)', 'type': 'DRUG', 'description': 'Participants will receive GIP subcutaneously.', 'armGroupLabels': ['Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide', 'Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide', 'Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide', 'Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide']}, {'name': 'Cagrilintide', 'type': 'DRUG', 'description': 'Participants will receive Cagrilintide subcutaneously.', 'armGroupLabels': ['Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide', 'Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide', 'Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide', 'Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide']}, {'name': 'Placebo GIP', 'type': 'DRUG', 'description': 'Participants will receive placebo matched to GIP subcutaneously.', 'armGroupLabels': ['Arm 1:Glucose dependent Insulinotropic Polypeptide(GIP)+Cagrilintide then Placebo GIP+Cagrilintide', 'Arm 2: Placebo GIP + Cagrilintide then GIP + Cagrilintide', 'Arm 3: GIP + Cagrilintide then Placebo GIP + Cagrilintide', 'Arm 4: Placebo GIP + Cagrilintide then GIP + Cagrilintide']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'HA1 3UJ', 'city': 'Harrow', 'state': 'Middlesex', 'country': 'United Kingdom', 'facility': 'Parexel Research Unit', 'geoPoint': {'lat': 51.57835, 'lon': -0.33208}}], 'centralContacts': [{'name': 'Novo Nordisk', 'role': 'CONTACT', 'email': 'clinicaltrials@novonordisk.com', 'phone': '(+1) 866-867-7178'}], 'overallOfficials': [{'name': 'Clinical Transparency (dept. 2834)', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novo Nordisk A/S'}]}, 'ipdSharingStatementModule': {'url': 'https://novonordisk-trials.com', 'ipdSharing': 'YES', 'description': 'According to the Novo Nordisk disclosure commitment on novonordisk-trials.com.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novo Nordisk A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}