Ignite Creation Date:
2025-12-24 @ 11:18 PM
Ignite Modification Date:
2025-12-25 @ 8:58 PM
Study NCT ID:
NCT05774756
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-07-02
First Post:
2023-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Trial of Setmelanotide in Acquired Hypothalamic Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050035', 'term': 'Sexual Infantilism'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-04-16', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-01', 'studyFirstSubmitDate': '2023-03-01', 'studyFirstSubmitQcDate': '2023-03-16', 'lastUpdatePostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean % change in BMI', 'timeFrame': 'From Baseline after 52 weeks on a therapeutic regimen'}], 'secondaryOutcomes': [{'measure': 'Proportion of patients with ≥5% reduction in BMI in adult patients (≥18 years of age) or a BMI Z-score reduction of ≥0.2 points in pediatric patients (<18 years of age)', 'timeFrame': 'From Baseline after 52 weeks on a therapeutic regimen'}, {'measure': 'Mean change in the weekly average of the daily most hunger score in patients ≥12 years old', 'timeFrame': 'From Baseline after 52 weeks on a therapeutic regimen'}, {'measure': 'Proportion of patients with a ≥2 point reduction in the weekly average of the daily most hunger score', 'timeFrame': 'From Baseline after 52 weeks on a therapeutic regimen'}, {'measure': 'Mean change in Symptoms of Hyperphagia total score', 'timeFrame': 'From Baseline after 52 weeks on a therapeutic regimen'}, {'measure': 'Proportion of patients with a ≥10% reduction in BMI', 'timeFrame': 'From Baseline after 52 weeks on a therapeutic regimen'}, {'measure': 'Mean percent change in weight in patients ≥18 years', 'timeFrame': 'From Baseline after 52 weeks on a therapeutic regimen'}, {'measure': 'Mean BMI-z score and BMI percentile reduction in patients <18 (using combined height and weight to report BMI in kg/m2)', 'timeFrame': 'From Baseline after 52 weeks on a therapeutic regimen'}, {'measure': 'Proportion of patients aged ≥4 to <18 years with ≥0.2-point reduction of BMI Z-score', 'timeFrame': 'From Baseline after 52 weeks on a therapeutic regimen'}, {'measure': 'Proportion of patients with BMI <30 kg/m2 (patients aged ≥18 years) or <95th percentile (patients aged <18 years)', 'timeFrame': 'From Baseline after 52 weeks on a therapeutic regimen'}, {'measure': 'Mean change in physical functioning score and total score for the Impact of Weight on Quality of Life-Lite (IWQOL)', 'timeFrame': 'From Baseline after 52 weeks on a therapeutic regimen'}, {'measure': 'Safety and tolerability of setmelanotide compared to placebo assessed by frequency and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs)', 'timeFrame': 'From Baseline after 52 weeks on a therapeutic regimen'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['melancortin 4 receptor, MC4R'], 'conditions': ['Hypothalamic Obesity']}, 'descriptionModule': {'briefSummary': 'The goal of this trial is to learn how well Setmelanotide works to improve weight reduction, hunger, and quality of life in patients 4 years of age and older with acquired Hypothalamic Obesity (HO). To determine how well setmelanotide works and how safe it is, patients with HO will take a daily injection of either setmelanotide or placebo and complete trial assessments for 52 weeks on a therapeutic regimen.\n\nA separate sub-study in patients with congenital HO is detailed under NCT06760546.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. Documented evidence of acquired hypothalamic obesity (HO)\n2. Age 4 years and older\n3. Weight gain associated with the hypothalamic injury and a BMI of ≥30 kg/m2 for patients ≥18 years of age or BMI ≥95th percentile for age and sex for patients 4 to \\<18 years of age\n4. Agree to use a highly effective form of contraception throughout the study and for 90 days after the study\n\nKey Exclusion Criteria:\n\n1. Diagnosis of Prader-Willi syndrome (PWS) or Rapid-onset obesity with hypoventilation, hypothalamic, autonomic dysregulation, neuroendocrine tumor syndrome (ROHHADNET)\n2. Weight loss \\>2% in the previous 3 months for patients aged ≥18 years or \\>2% reduction in BMI for patients aged 4 to \\<18 years\n3. Bariatric surgery or procedure within last 2 years\n4. Diagnosis of severe psychiatric disorders; any suicidal ideation, attempt or behavior\n5. Current, clinically significant pulmonary, cardiac, metabolic, or oncologic disease\n6. Significant dermatologic findings relating to melanoma or pre-melanoma skin lesions (excluding non-invasive basal or squamous cell lesion)\n7. History or close family history of skin cancer or melanoma\n8. Participation in any clinical trial with an investigational drug/device within 3 months prior to the first trial dose\n9. Previously enrolled in a clinical trial involving setmelanotide or any previous exposure to setmelanotide\n10. Inability to comply with once daily (QD) injection regimen\n11. If female, pregnant and/or breastfeeding\n12. Patients with obesity attributable to other genetic or syndromic conditions (eg, PPL \\[POMC, PCSK1, LEPR, collectively\\], BBS) prior to the hypothalamic injury.\n13. If receiving hormone replacement therapy, dose has remained stable for at least 2 months before Screening\n\nOther protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05774756', 'briefTitle': 'A Trial of Setmelanotide in Acquired Hypothalamic Obesity', 'organization': {'class': 'INDUSTRY', 'fullName': 'Rhythm Pharmaceuticals, Inc.'}, 'officialTitle': 'A Phase 3, Double Blind, Randomized, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Setmelanotide in Patients With Acquired Hypothalamic Obesity', 'orgStudyIdInfo': {'id': 'RM-493-040'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Setemelanotide', 'description': 'Randomized 2:1 (Setmelanotide: Placebo)', 'interventionNames': ['Drug: Setmelanotide']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Randomized 2:1 (Setmelanotide: Placebo)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Setmelanotide', 'type': 'DRUG', 'otherNames': ['RM-493', 'Imcivree'], 'description': 'Solution for daily subcutaneous injection', 'armGroupLabels': ['Setemelanotide']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo matched to setmelanotide for daily subcutaneous injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'UAN Pediatric Endocrinology', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': "Rady Children's Hospital", 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': "Children's Hospital Colorado", 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32610-0296', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Ann and Robert H. Lurie Children's Hospital", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Stead Family Department of Pediatrics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Boston Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': "Children's Minnesota", 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '100029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Icahn School of Medicine at Mount Sinai', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Irving Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '43203', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State Wexner Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73122', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Lynn Health Science Institute', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University School of Medicine', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital, Research and Foundation - Center for Integrative Brain Research", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'M5G 1X8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': '20246', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Universitaetsklinikum Hamburg-Eppendorf (UKE) - Ambulanzzentrum des UKE GmbH', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'zip': '81667', 'city': 'München', 'country': 'Germany', 'facility': 'Medicover Neuroendokrinologie', 'geoPoint': {'lat': 51.60698, 'lon': 13.31243}}, {'zip': '26133', 'city': 'Oldenburg', 'country': 'Germany', 'facility': "University Children's Hospital, Klinikum Oldenburg", 'geoPoint': {'lat': 53.14039, 'lon': 8.21479}}, {'zip': '89075', 'city': 'Ulm', 'country': 'Germany', 'facility': 'Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'zip': '467-8602', 'city': 'Nagoya', 'state': 'Aichi-ken', 'country': 'Japan', 'facility': 'Nagoya City University Hospital', 'geoPoint': {'lat': 35.18147, 'lon': 136.90641}}, {'zip': '399-8288', 'city': 'Azumino', 'state': 'Nagano', 'country': 'Japan', 'facility': "Nagano Children's Hospital", 'geoPoint': {'lat': 36.28815, 'lon': 137.88705}}, {'zip': '105-8470', 'city': 'Minato', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Toranomon Hospital', 'geoPoint': {'lat': 35.6581, 'lon': 139.7515}}, {'zip': '3584CS', 'city': 'Utrecht', 'country': 'Netherlands', 'facility': 'Prinses Maxima Center for Pediatric Oncology', 'geoPoint': {'lat': 52.09083, 'lon': 5.12222}}, {'zip': 'B46NH', 'city': 'Birmingham', 'country': 'United Kingdom', 'facility': "Birmingham Women and Children's Hospital NHS Trust", 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}, {'zip': 'HU32RW', 'city': 'Hull', 'country': 'United Kingdom', 'facility': 'Hull University Teaching Hospital', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'zip': 'WC1N 1EH', 'city': 'London', 'country': 'United Kingdom', 'facility': 'UCL Great Ormond Street Institute of Child Health', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], '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'}}}}