Metreleptin in Anorexia Nervosa

NCT06305182 | Recruiting Phase 2 DMC

• 1 other identifier: BASEC 2022-01328
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anorexia Nervosa

Keywords

Anorexia Nervosa; Leptin; Metreleptin; Weight gain; Depression

Outcome Measures

Primary Outcomes (2)

• 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

  HAMD-17 is a semi-structured interview and consists of 17 items assessing symptoms of depression from the perspective of the clinician. Possible scores range from 0 (no depressive symptom) to 4 (strong depressive symptom). The higher the total score, the more severe the depressive symptoms.

  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

  Body weight status will be indicated by weight in kilograms (kg).

  Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)

Secondary Outcomes (62)

• Subjective depression by the Beck Depression Inventory-II (BDI-II) 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)

• Functional brain connectivity 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)

• Anorexia Nervosa psychopathology assessed by the Eating Disorders Examination Questionnaire (EDE-Q) 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)

• External rated hyperkinesia assessed by the Structured Inventory for Anorexic and Bulimic Eating Disorders (SIAB, item 42) 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)

• Subjective hyperkinesia assessed by the Exercise and Eating Disorders Questionnaire (EED) 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)

Study Arms (2)

Metreleptin-assisted therapy

EXPERIMENTAL

25 patients will receive a daily subcutaneous injection of metreleptin for 14 days. The dose starts with 0.4 ml daily, and gradually increases until 1.8 ml; until 1.2 ml in male patients daily.

Placebo-therapy

PLACEBO COMPARATOR

25 patients will receive a daily subcutaneous injection of inactive substance (placebo) for 14 days. To ensure blinding, the dosing scheme of placebo will have the identical volume to the dosing scheme of metreleptin (verum).

Drug: Sodium chloride

Interventions

Metreleptin DRUG

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.

Also known as: Myalept®

Sodium chloride DRUG

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.

Placebo-therapy

Eligibility Criteria

• Age: 17 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gabriella Milos: lead

Study Sites (1)

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

Zurich, Canton of Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Anorexia Nervosa; Weight Gain; Depression

Interventions

metreleptin; Sodium Chloride

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Gabriella Milos, Prof. Dr. med.

CONTACT

0041 44 255 52 80; Gabriella.Milos@usz.ch

Lisa Guth, MSc Psychology

CONTACT

0041 44 255 97 17; Lisa.Guth@usz.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Placebo-controlled, double-blind, randomized trial. The efficacy of Metreleptin in Anorexia Nervosa patients will be tested against an inactive Placebo.

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: March 12, 2024
• Study Start: May 31, 2024
• Primary Completion (Estimated): August 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: January 15, 2026

Record last verified: 2025-05

Locations

CH (1)