nctId: NCT06305182 id: BASEC 2022-01328 briefTitle: Metreleptin in Anorexia Nervosa acronym: METRAN overallStatus: NOT_YET_RECRUITING date: 2024-04-01 date: 2026-02-01 date: 2026-02-01 date: 2024-03-12 date: 2024-03-15 name: Gabriella Milos class: OTHER 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. conditions: Anorexia Nervosa studyType: INTERVENTIONAL phases: PHASE2 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 masking: QUADRUPLE whoMasked: PARTICIPANT whoMasked: CARE_PROVIDER whoMasked: INVESTIGATOR whoMasked: OUTCOMES_ASSESSOR count: 50 type: ESTIMATED name: Metreleptin name: Sodium chloride 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 measure: Body weight status in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up 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 measure: Functional brain connectivity in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up 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 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 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 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 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 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 measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Hematology in the Metreleptin treatment group compared to placebo group between measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Hematology in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Blood chemistry in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up measure: Neuroendocrinological blood parameters in the Metreleptin treatment group compared to placebo group between Baseline, Post Treatment and 5 weeks Follow Up sex: ALL minimumAge: 18 Years maximumAge: 40 Years stdAges: ADULT facility: Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich city: Zurich zip: 8091 country: Switzerland name: Florian Remund, MSc. Business Administration role: CONTACT name: Gabriella Milos, Prof. Dr. med. role: PRINCIPAL_INVESTIGATOR name: Lisa Guth, MSc role: SUB_INVESTIGATOR lat: 47.36667 lon: 8.54999 hasResults: False