Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-31 @ 8:10 PM
Study NCT ID:
NCT06596135
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-09-04
First Post:
2024-09-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-Label Extension Study of Setmelanotide
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050035', 'term': 'Sexual Infantilism'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'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'}, {'id': 'D006059', 'term': 'Gonadal Dysgenesis'}, {'id': 'D012734', 'term': 'Disorders of Sex Development'}, {'id': 'D014564', 'term': 'Urogenital Abnormalities'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D007006', 'term': 'Hypogonadism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C579663', 'term': 'setmelanotide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2024-09-10', 'studyFirstSubmitQcDate': '2024-09-13', 'lastUpdatePostDateStruct': {'date': '2025-09-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability of setmelanotide assessed by frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'Up to 3 years'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['setmelanotide', 'RM-493', 'obesity', 'melanocortin 4 receptor', 'hypothalamic obesity'], 'conditions': ['Obesity Associated With Defects in Leptin-melanocortin Pathway']}, 'descriptionModule': {'briefSummary': 'This is an open-label extension study designed to evaluate the long-term safety and tolerability of continued setmelanotide treatment in male and female patients ≥2 years of age who have completed or transitioned from a previous study with setmelanotide for rare genetic, syndromic, or acquired diseases of obesity upstream of the MC4R pathway.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Males and females ≥2 years of age who have completed a previous setmelanotide clinical study and who have a condition or indication for which Rhythm plans further clinical development.\n* Agree to use a highly effective form of contraception and follow the study contraception requirements throughout study duration and for 90 days after.\n* Demonstrated clinical benefit in the previous setmelanotide study, as determined by the Investigator.\n\nKey Exclusion Criteria:\n\n* Any gene variant, syndromic, or acquired disease for which setmelanotide is currently approved in the United States (i.e., patients eligible for commercial setmelanotide (IMCIVREE®).\n* Any new or worsening depression resulting in suicidal thoughts and/or behaviors.\n* Discontinuation from a previous setmelanotide study.\n* History or close family history (parents or siblings) of melanoma.\n* Pregnant and/or breastfeeding women\n\nOther protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT06596135', 'briefTitle': 'Open-Label Extension Study of Setmelanotide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rhythm Pharmaceuticals, Inc.'}, 'officialTitle': 'Open-Label Extension Study of Setmelanotide in Patients With a Rare Genetic, Syndromic or Acquired Disease of the MC4R Pathway', 'orgStudyIdInfo': {'id': 'RM-493-042'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Setelanotide (Open-label)', 'description': 'Once daily (QD) subcutaneous injection of setmelanotide', 'interventionNames': ['Drug: Setmelanotide']}], 'interventions': [{'name': 'Setmelanotide', 'type': 'DRUG', 'otherNames': ['RM-493', 'Imcivree'], 'description': 'Open-label daily injections of setmelanotide', 'armGroupLabels': ['Setelanotide (Open-label)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'HonorHealth Research Institute', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "UC San Diego- Rady Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '32611', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida at Gainesville', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Minnesota", 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '14068', 'city': 'Getzville', 'state': 'New York', 'country': 'United States', 'facility': 'University of Buffalo', 'geoPoint': {'lat': 43.02395, 'lon': -78.76781}}, {'zip': '27612', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'M3 Wake Research, Inc', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '17821', 'city': 'Danville', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Geisinger Health System', 'geoPoint': {'lat': 40.96342, 'lon': -76.61273}}, {'zip': '37421', 'city': 'Chattanooga', 'state': 'Tennessee', 'country': 'United States', 'facility': 'WR-ClinSearch', 'geoPoint': {'lat': 35.04563, 'lon': -85.30968}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University School of Medicine', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Research Institute", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '54449', 'city': 'Marshfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Marshfield Clinical Research Institute', 'geoPoint': {'lat': 44.66885, 'lon': -90.1718}}], 'overallOfficials': [{'name': 'David Meeker, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Rhythm Pharmaceuticals, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rhythm Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}