Metreleptin in Anorexia Nervosa

Last updated: May 9, 2025
Sponsor: Gabriella Milos
Overall Status: Active - Recruiting

Phase

2

Condition

Anorexia

Vomiting

Treatment

Metreleptin

Sodium chloride

Clinical Study ID

NCT06305182
BASEC 2022-01328
  • Ages 17-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Main key inclusion criteria:

  • Current diagnosis of AN according to fifth edition of the Diagnostic and StatisticalManual of Mental Disorders (DSM-5) confirmed with Structured Clinical Interview forDSM-5 (SCID-5)

  • BMI > 13 kg/m2; BMI ≤ 18 kg/m2; body weight > 35 kg

  • Hospitalisation in the Eating Disorders Unit, Department of Consultation-LiaisonPsychiatry and Psychosomatic Medicine, University Hospital of Zurich

  • Ability to understand German language

  • Age range: 17 - 65 years

  • Depressive symptoms: HAMD-17 ≥ 8

  • Negative pregnancy test, non-lactating and double birth control

  • Informed Consent as documented by signature

Exclusion

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 ofschizophrenia, bipolar disorder, inflammatory bowel disorders, diabetes mellitus,autoimmune disorders, pancreatitis, neurological disorders, cancer includinglymphoma

  • Acute suicidality or current serious non-suicidal self-injury

Study Design

Total Participants: 50
Treatment Group(s): 2
Primary Treatment: Metreleptin
Phase: 2
Study Start date:
May 31, 2024
Estimated Completion Date:
August 30, 2026

Study Description

Anorexia nervosa (AN) mainly affects young people, especially young women. AN is one of the most lethal psychiatric disorders. Treatment often proves to be very difficult, and AN course is frequently chronic. Specific pharmacological therapies for AN are lacking. Recent studies have shown that metabolic alterations play a great role in the etiology and pathogenesis of AN. An important metabolic alteration playing a role in the etiology and pathogenesis of AN is the hormone leptin. Patients with AN show hypoleptinemia. The role of hypoleptinemia in the neuroendocrine adaptation to starvation seems to induce emotional, cognitive, and behavioral symptoms of AN. From a theoretical point of view, pharmacotherapy augmenting leptin levels in patients with AN have a great therapeutic potential. Recently, positive effects with experimental administration of subcutaneous metreleptin in few young patients with severe AN have been observed. Importantly, no side effects have been observed. For all these reasons, the present study will investigate - with a double blind design - the therapeutic effect of metreleptin in patients with AN. Metreleptin will be administrated to 50 AN-inpatients: 25 patients will receive verum and 25 will receive placebo during 14 days. Primary objectives of this study are the amelioration of mood and weight. Secondary objectives are the investigation of functional brain connectivity, AN symptoms, as well as hematologic, blood chemistry and neuroendocrinological hormones.

Connect with a study center

  • Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich

    Zurich, 8091
    Switzerland

    Site Not Available

  • Eating Disorder Unit, Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich

    Zurich, 8091
    Switzerland

    Active - Recruiting

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