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RecruitingPhase 2NCT06305182

Metreleptin in Anorexia Nervosa

Metreleptin in Anorexia Nervosa, Randomized Controlled Trial; Effects on Depressive Symptoms and Concomitant Changes in Brain Connectivity

Sponsor

Gabriella Milos

Enrollment

50 participants

Start Date

May 31, 2024

Study Type

INTERVENTIONAL

Conditions

Anorexia Nervosa

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

Min Age: 17 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether metreleptin — a hormone normally low in people who are very underweight — can help treat anorexia nervosa, particularly its associated depression symptoms. **You may be eligible if...** - You have a confirmed diagnosis of anorexia nervosa (DSM-5 criteria) - Your BMI is between 13 and 18 kg/m² and your body weight is at least 35 kg - You are between 17 and 65 years old - You are currently hospitalized in an eating disorders unit at University Hospital of Zurich - You have moderate-to-severe depressive symptoms (score of 8 or higher on the Hamilton Depression scale) - You can understand German - You are not pregnant and are using effective contraception **You may NOT be eligible if...** - You have used illicit drugs in the past month or currently have an alcohol use disorder - You have severe psychiatric or serious physical health conditions alongside your eating disorder Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMetreleptin

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.

DRUGSodium 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.

Locations(1)

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

Zurich, Canton of Zurich, Switzerland

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NCT06305182

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