Metreleptin in Anorexia Nervosa

Launched by GABRIELLA MILOS · Mar 7, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called metreleptin for people with anorexia nervosa, a serious eating disorder that is often hard to treat. The researchers want to see if metreleptin, which is a synthetic version of a hormone that helps regulate body weight, can reduce the symptoms of anorexia, improve mood, and help participants gain weight. In this study, some participants will receive metreleptin while others will receive a placebo, which looks like the treatment but has no active ingredients. This trial is important because there are currently no specific medications approved for treating anorexia nervosa.

To participate in the trial, individuals need to be between 18 and 40 years old, currently diagnosed with anorexia nervosa, and have a specific body weight range. They also need to be able to understand German and provide informed consent. Participants will be closely monitored throughout the study, and their progress will be assessed regularly. It’s important to note that individuals with certain severe mental health or medical conditions, as well as those with substance use issues, will not be eligible to join the trial. This study is currently recruiting participants, and it aims to find new ways to help those struggling with this challenging condition.

Gender

ALL

Eligibility 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 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