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Metreleptin in Anorexia Nervosa

RecruitingPhase 2Ages 17 Years - 65 YearsAllGabriella Milos
NCT06305182 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Main key inclusion criteria: * Current diagnosis of AN according to fifth edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) confirmed with Structured Clinical Interview for DSM-5 (SCID-5) * BMI \> 13 kg/m2; BMI ≤ 18 kg/m2; body weight ≥ 35 kg * Hospitalisation in the Eating Disorders Unit, Department of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital of Zurich * Ability to understand German language * Age range: 17 - 65 years * Depressive symptoms: HAMD-17 ≥ 8 * Negative urine pregnancy test, non-lactating and double birth control * Informed Consent as documented by signature Main key exclusion criteria: * Illicit drug intake within last month; current alcohol use disorder * Severe psychiatric and/or severe somatic comorbidities; f. e. lifetime diagnosis of schizophrenia, bipolar disorder, inflammatory bowel disorders, diabetes mellitus, autoimmune disorders, pancreatitis, neurological disorders, cancer including lymphoma * Acute suicidality or current serious non-suicidal self-injury
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What it tests

  • Metreleptin
  • Sodium chloride
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Where

1 site
Eating Disorder Unit, Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich
Zurich, Switzerland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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