Metreleptin in Anorexia Nervosa
Recruiting · NCT06305182 · Interventional (participants receive a specific treatment) · Lead sponsor: Gabriella Milos
View the official record on ClinicalTrials.gov →Interventions studied
MetreleptinSodium chloride
What this trial is about
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.
Who can take part
Age range
17 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- Eating Disorder Unit, Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich - Zurich, Canton of Zurich, Switzerland