protocolSection identificationModule nctId: NCT06305182, orgStudyIdInfo id: BASEC 2022-01328, briefTitle: Metreleptin in Anorexia Nervosa, acronym: METRAN, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2026-02-01, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-15, sponsorCollaboratorsModule leadSponsor name: Gabriella Milos, class: OTHER, descriptionModule briefSummary: The treatment of anorexia nervosa often proves to be difficult. There are no drugs that work specifically for the treatment of anorexia nervosa. Experimental administration of metreleptin (synthetically produced leptin) to patients with anorexia nervosa has produced positive results. This study tests the effect of metreleptin in comparison with placebo, which could potentially make treatment easier. The aim of the study is to investigate whether treatment with metreleptin can help to reduce the symptoms of anorexia nervosa and improve mood and weight., conditionsModule conditions: Anorexia Nervosa, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Placebo-controlled, double-blind, randomized trial. The efficacy of Metreleptin in Anorexia Nervosa patients will be tested against an inactive Placebo., primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Metreleptin, interventions name: Sodium chloride, outcomesModule primaryOutcomes measure: Clinician-rated depression on the 17 point Hamilton Depression Scale (HAMD-17) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, primaryOutcomes measure: Body weight status in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Subjective depression by the Beck Depression Inventory-II (BDI-II) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Functional brain connectivity in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Anorexia Nervosa psychopathology assessed by the Eating Disorders Examination Questionnaire (EDE-Q) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: External rated hyperkinesia assessed by the Structured Inventory for Anorexic and Bulimic Eating Disorders (SIAB, item 42) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Subjective hyperkinesia assessed by the Exercise and Eating Disorders Questionnaire (EED) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Autism symptoms assessed by the Autism-Spectrum Quotient-short version (AQ-k) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Patient's quality of life by items 1, 2, 5, 6, 7, 10, 17, 19, 20, and 22 from the WHO Quality of Life Questionnaire (WHOQOL-BREF) in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Visual Analog Scale (VAS) about key Anorexia Nervosa and depression symptoms in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Hematology in the Metreleptin treatment group compared to placebo group between, secondaryOutcomes measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, secondaryOutcomes measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, city: Zurich, zip: 8091, country: Switzerland, contacts name: Florian Remund, MSc. Business Administration, role: CONTACT, contacts name: Gabriella Milos, Prof. Dr. med., role: PRINCIPAL_INVESTIGATOR, contacts name: Lisa Guth, MSc, role: SUB_INVESTIGATOR, geoPoint lat: 47.36667, lon: 8.54999, hasResults: False