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Metreleptin in Anorexia Nervosa

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…

ClinicalTrials.gov IDNCT06305182

PhasePHASE2

Enrollment50

SponsorGabriella Milos

Age17 Years

SexALL

I'm interested View official listing

Conditions studied

Anorexia Nervosa

About this study

Interventions

Drug: Metreleptin — Metreleptin 3 mg is packaged in 3 ml Type I glass vials with chlorobutyl rubber stoppers, and aluminum seals with plastic flip-off caps. The vials are stored in refrigerator (2 - 8°C) and protected from light. Metreleptin for injection is a sterile, white, solid lyophilised cake. Prior to patient use, the content of a vial is reconstituted with 0.6 ml of water for injection for a final formulation of 10 millimolar (mM) glutamic acid, 2% glycine, 1% sucrose, 0.01% polysorbate 20, potential hydrogen (pH) 4.25. The resulting solution is administered by subcutaneous injection.
Drug: Sodium chloride — The placebo will consist of sterile 0.9% saline (Sodium chloride), drawn up from a 10 ml i.v. vials. The placebo will be administered as an subcutaneous injection in an identical procedure as the metreleptin verum.

Primary outcomes

Clinician-rated depression on the 17 point Hamilton Depression Scale (HAMD-17) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up (Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49))
Body weight status in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up (Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49))

Eligibility information

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

Study locations

Eating Disorder Unit, Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich, Zurich, Canton of Zurich 8091 Switzerland

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.