Using metreleptin to treat anorexia nervosa
Metreleptin in Anorexia Nervosa, Randomized Controlled Trial; Effects on Depressive Symptoms and Concomitant Changes in Brain Connectivity
This study is testing if a hormone treatment called metreleptin can help people with anorexia nervosa improve their mood and gain weight.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 17 Years to 65 Years |
| Sex | All |
| Sponsor | University of Zurich Academic / other |
| Locations | 1 site (Zurich, Canton of Zurich) |
| Trial ID | NCT06305182 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of metreleptin, a synthetic form of the hormone leptin, on patients diagnosed with anorexia nervosa. It employs a double-blind, placebo-controlled design, where 50 inpatients will receive either metreleptin or a placebo for 14 days. The primary goals are to assess improvements in mood and weight, while secondary objectives include evaluating brain connectivity and various health parameters. The study aims to provide a potential pharmacological treatment for a condition that currently lacks effective medications.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 17 to 65 with a current diagnosis of anorexia nervosa and specific BMI requirements.
Not a fit: Patients with severe psychiatric or somatic comorbidities or those currently using illicit drugs or alcohol may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve mood and weight in patients suffering from anorexia nervosa.
How similar studies have performed: Previous studies have shown positive effects of metreleptin in small cohorts, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Zurich, Canton of Zurich
- Eating Disorder Unit, Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich — Zurich, Canton of Zurich, Switzerland (Recruiting)
Study contacts
- Study coordinator: Gabriella Milos, Prof. Dr. med.
- Email: Gabriella.Milos@usz.ch
- Phone: 0041 44 255 52 80
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.