Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
Study NCT ID:
NCT06484868
Status:
RECRUITING
Last Update Posted:
2025-07-03
First Post:
2024-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562448', 'term': 'Lipodystrophy, Partial, Acquired'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C415771', 'term': 'metreleptin'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 12}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-02', 'studyFirstSubmitDate': '2024-06-26', 'studyFirstSubmitQcDate': '2024-06-26', 'lastUpdatePostDateStruct': {'date': '2025-07-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of patients with decrease of at least 0.5% in glycated haemoglobin (HbA1c) at Month 12 compared to Baseline or HbA1c <6.5 % at Month 12, in patients with baseline HbA1c ≥6.5%.', 'timeFrame': '12 months', 'description': 'To evaluate the efficacy (HbA1c) of metreleptin treatment in patients with PL'}, {'measure': 'Number of patients with decrease of at least 30% in triglycerides (TG) at Month 12 compared to Baseline, in patients with baseline TG levels ≥500 mg/dL (5.65 mmol/L)', 'timeFrame': '12 months', 'description': 'To evaluate the efficacy (TG) of metreleptin treatment in patients with PL'}], 'secondaryOutcomes': [{'measure': 'Number of patients with decrease of at least 0.5% in HbA1c at Month 24 compared to Baseline or HbA1c <6.5 % at Month 24, in patients with baseline HbA1c ≥6.5%.', 'timeFrame': '24 months', 'description': 'To evaluate the long-term efficacy of metreleptin treatment in patients with PL'}, {'measure': 'Number of patients with decrease of at least 30% in TG levels at Month 24 compared to Baseline, in patients with baseline TG levels ≥500 mg/dL (5.65 mmol/L).', 'timeFrame': '24 months', 'description': 'To evaluate the long-term efficacy of metreleptin treatment in patients with PL'}, {'measure': 'Change from baseline in liver volume at Month 12 and Month 24', 'timeFrame': '12 months and 24 months', 'description': 'To assess changes in liver volume.'}, {'measure': 'Incidence of, Treatment emergent adverse events (TEAEs), Deaths and other serious adverse events (SAEs), Treatment related adverse events (AEs), AEs of special interest (AESIs) and AEs leading to study drug discontinuation', 'timeFrame': '24 months', 'description': 'To evaluate the safety of metreleptin treatment in patients with PL'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Metreleptin'], 'conditions': ['Partial Lipodystrophy']}, 'descriptionModule': {'briefSummary': 'This is an Open Label, Phase IV, Post Authorisation Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in people with Partial Lipodystrophy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed diagnosis of familial or acquired partial lipodystrophy\n\nExclusion Criteria:\n\n* Treatment with any Investigational Medicinal Product (IMP) within 6 months or 5 times the terminal half-life of the corresponding IMP, whichever is longer, before the screening visit.\n\nOther protocol defined inclusion/exclusion criteria apply'}, 'identificationModule': {'nctId': 'NCT06484868', 'briefTitle': 'Open-label Study to Evaluate Metreleptin in Patients With Partial Lipodystrophy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amryt Pharma'}, 'officialTitle': 'A 24-Month, Multi-Centre, Open Label Phase IV Post Authorisation Efficacy Study to Evaluate the Efficacy, Safety and Immunogenicity of Daily Subcutaneous Metreleptin Treatment in Patients With Partial Lipodystrophy', 'orgStudyIdInfo': {'id': 'APL-22'}, 'secondaryIdInfos': [{'id': '2022-502950-14-00', 'type': 'CTIS'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Metreleptin', 'description': 'Metreleptin \\[Recombinant-methionyl human Leptin; r-metHuLeptin\\] for daily injection is a sterile, white, solid lyophilised cake', 'interventionNames': ['Drug: Metreleptin']}], 'interventions': [{'name': 'Metreleptin', 'type': 'DRUG', 'description': 'Metreleptin is a recombinant human leptin analog that is indicated as an adjunct to diet as replacement therapy to treat the complications of leptin deficiency', 'armGroupLabels': ['Metreleptin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lille', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Marie-Christine Vantyghem', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez', 'geoPoint': {'lat': 50.63391, 'lon': 3.05512}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Fabrizio Andreelli', 'role': 'CONTACT'}], 'facility': 'Hopital Pitie-Salpetriere', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Corinne Vigouroux', 'role': 'CONTACT'}], 'facility': 'Hôpital Saint-Antoine', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Pierre-Bénite', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Emmanuel Disse', 'role': 'CONTACT'}], 'facility': 'Centre Hospitalier Lyon-Sud', 'geoPoint': {'lat': 45.70359, 'lon': 4.82424}}, {'city': 'Berlin', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Thomas Bobbert', 'role': 'CONTACT'}], 'facility': 'Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'city': 'Ulm', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Martin Wabitsch', 'role': 'CONTACT'}], 'facility': 'Universitaetsklinikum Ulm - Klinik fuer Kinder- und Jugendmedizin', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'city': 'Bologna', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Gambineri', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero-Universitaria di Bologna Policlinico S. Orsola-Malpighi', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}, {'city': 'Catanzaro', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonio Aversa', 'role': 'CONTACT'}], 'facility': 'Universitá degli Studi "Magna Graecia" di Catanzaro', 'geoPoint': {'lat': 38.88247, 'lon': 16.60086}}, {'city': 'Novara', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Flavia Prodam', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero Universitaria Maggiore della Carità di Novara', 'geoPoint': {'lat': 45.44694, 'lon': 8.62118}}, {'city': 'Pisa', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giovanni Ceccarini', 'role': 'CONTACT'}], 'facility': 'Azienda Ospedaliero Universitaria Pisana - Stabilimento di Cisanello', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}, {'city': 'Udine', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annalisa Sechi', 'role': 'CONTACT'}], 'facility': 'A.S.U Integrata di Udine - Presidio Ospedaliero Santa Maria della Misericordia', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}, {'city': 'Cambridge', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Anna Stears', 'role': 'CONTACT'}], 'facility': 'Cambridge University Hospitals NHS Foundation Trust - Addenbrookes Hospital', 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}], 'centralContacts': [{'name': 'Janet Boylan', 'role': 'CONTACT', 'email': 'clinicaltrials_info@chiesi.com', 'phone': '+3905212791'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amryt Pharma', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}