Anorexia NervosaPhase 2METRANNCT06305182
Metreleptin in Anorexia Nervosa
A Phase 2 study testing Metreleptin and Sodium chloride in people with Anorexia Nervosa, run by Gabriella Milos at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Anorexia Nervosa
- What is being tested?
- Metreleptin and Sodium chloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 31 May 2024to 31 Dec 2026
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Eating Disorder Unit, Clinic of Consultation-Liaison Psychiatry and Psychosomatic Medicine, University Hospital Zurich
Zurich, Canton of Zurich, 8091
Deborah Felder, +41 44 255 52 51, Deborah.Felder@usz.ch
Gabriella Milos, Prof. Dr. med.
About this study
Official title: Metreleptin in Anorexia Nervosa, Randomized Controlled Trial; Effects on Depressive Symptoms and Concomitant Changes in Brain Connectivity
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.
Read the detailed description
Anorexia nervosa (AN) mainly affects young people, especially young women. AN is one of the most lethal psychiatric disorders. Treatment often proves to be very difficult, and the course of AN is frequently chronic. Specific pharmacological therapies for AN are lacking. Recent studies have shown that metabolic alterations play a major role in the etiology and pathogenesis of AN. An important metabolic alteration involved in the etiology and pathogenesis of AN is the hormone leptin. Patients with AN show hypoleptinemia. The role of hypoleptinemia in the neuroendocrine adaptation to starvation seems to induce emotional, cognitive, and behavioral symptoms of AN. From a theoretical point of view, pharmacotherapy aimed at increasing leptin levels in patients with AN has great therapeutic potential. Recently, positive effects following the experimental administration of subcutaneous metreleptin have been observed in small number of young patients with severe AN. Importantly, no side effects have been observed. For all these reasons, the present study will investigate, using a double-blind design, the therapeutic effect of metreleptin in patients with AN. Metreleptin will be administrated to 50 inpatients with AN: 25 patients will receive verum and 25 will receive placebo for 14 days. The primary objectives of this study are the amelioration of mood and weight. Secondary objectives are the investigation of functional brain connectivity, AN symptoms, as well as hematological, blood chemistry and neuroendocrinological parameters.
- Conditions
- Anorexia Nervosa
- Being tested
- Metreleptin, Sodium chloride
- Keywords
- Anorexia Nervosa, Leptin, Metreleptin, Weight gain, Depression
- Medical subject headings
- Anorexia Nervosa, Weight Gain, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetreleptinDrug
Also called Myalept®
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.
Sodium chlorideDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Drug: Sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: 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
The Beck Depression Inventory-II is a self-report rating inventory that measures characteristic attitudes and symptoms of depression with 21 items, ranging from 0 (no depressive symptoms) to 3 (strong depressive symptoms). The higher the total score, the more severe the depressive symptoms.
Measured: 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
For assessment of intrinsic functional connectivity in the brain, functional MRI images will be acquired for each patient. A region-of-interest analysis and calculating correlations between any pair of two brain regions, obtaining a connectivity matrix, will be done.
Measured: 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
The Eating Disorders Examination Questionnaire (EDE-Q) is the self-report version of the Eating Disorder Examination (EDE). The 22 items on the four subscales of restraint, eating concern, weight concern, and shape concern are used to assess eating disorder-specific characteristics in their current manifestations during the last 28 days. 7-point rating scales are used to assess frequencies from 0 (characteristic was not present) to 6 (characteristic was present every day or to an extreme degree). Six further, non-scale-forming items also measure the frequency of diagnostically relevant core behaviors over the last 28 days. The EDE-Q is evaluated by calculating subscale mean values for the Restraint, Eating Concern, Weight Concern and Shape Concern subscales and a total score. At Baseline, Post Treatment and intermediate measurements, the instruction of EDE-Q will be modified to refer to a shortened shortened observation time (last week).
Measured: 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
Hyperkinesia will be assessed with only one item (item 42) from the Structured Inventory for Anorexic and Bulimic Eating Disorders (SIAB). This Inventory is used to record the entire spectrum of eating disorder symptoms. Item 42 assesses excessive physical exercise ranging from 0 (no physical exercise) to 4 (very frequent physical exercise).
Measured: 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
The Exercise and Eating Disorders Questionnaire (EED) is a clinically derived, self-report questionnaire. 19 items are used to assess compulsive exercise among eating disorder patients. The 6-point rating scale is used to assess the frequencies (never, rare, sometimes, often, mostly, always) during the last 4 weeks. A higher total score indicates a stronger manifestation of compulsive exercises.
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Autism symptoms assessed by the Autism-Spectrum Quotient-short version (AQ-k) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
The Autism-Spectrum Quotient-short version (AQ-k) is a self-assessment tool for screening for autistic disorder. The 10 items represent autistic symptoms and a 4-point response scale is used to assess the agreement (complete agreement, agree more, rather disagree, complete disagreement) to those.
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Patient's quality of life by items 1, 2, 5, 6, 7, 10, 17, 19, 20, and 22 from the WHO Quality of Life Questionnaire (WHOQOL-BREF) in the metreleptin-assisted therapy group compared to placebo-therapy between Baseline, Post Treatment and 5 weeks Follow Up
The WHO Quality of Life Questionnaire (WHOQOL-BREF) with 26 items is a short form of the WHOQOL-100 and is an instrument for recording subjective quality of life. Items 1, 2, 5, 6, 7, 10, 17, 19, 20, and 22 will be used, ranging from 1 (very dissatisfied/ no agreement) to 5 (very satisfied/fully agreement). A higher total score indicates a increased quality of life.
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Visual Analog Scale (VAS) about key Anorexia Nervosa and depression symptoms in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
10 items assessing hunger, repetitive thought of food, fear of weight gain, drive for activity, inner tension, feeling full, nausea, feeling fat, depressed mood and feeling tired on a 10-point response scale ranging from 1 (not pronounced symptom) to 10 (strongly pronounced symptom).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Social interaction by the Liebowitz Social Anxiety Scale (LSAS) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
The Liebowitz Social Anxiety Scale is a clinician-administered assessment that measures the fear and avoidance associated with social anxiety. Item 2,3,4,5,8,10,11,12,15 and 19 will be rated on the response scale for avoidance behavior from 1 (never) to 4 (almost always). Higher scores indicating greater severity of social anxiety.
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Anhedonia by the Snaith-Hamilton Pleasure Scale (SHAPS-D) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Anhedonia will be assessed with the german version of the Snaith-Hamilton Pleasure Scale (SHAPS-D) that assesses self-reported anhedonia in psychiatric patients. The respective degree of consent regarding the 14 items on the questionnaire will be rated on a bipolar four-point response scale. For the evaluation, each disagree response ('disagree' or 'strongly disagree') is given 1 point and each agree response is given 0 points. By adding up the points, a higher value indicates a greater degree of anhedonia.
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with hemoglobin grams per liter (g/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with hematocrit liter per liter (l/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with erythrocytes Tera per liter (T/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with thrombocytes Giga per liter (G/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with leucocytes Giga per liter (G/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with Sodium millimoles per liter (mmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with potassium millimoles per liter (mmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with phosphate millimoles per liter (mmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with creatinine micromoles per liter (µmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with creatinine kinase Units per liter (U/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with estimated Glomerular Filtration Rate (eGFR) milliliters per minute (ml/min).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with bilirubin total micromoles per liter (µmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with gamma-glutamyltranspeptidase Units per liter (U/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with alanine aminotransferase Units per liter (U/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with alkaline phosphatase Units per liter (U/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with pancreatic amylase Units per liter (U/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with lipase Units per liter (U/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with C-reactive protein (CRP) milligrams per liter (mg/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with calcium millimoles per liter (mmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with chloride millimoles per liter (mmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with aspartat-aminostransf. (GOT) Units per liter (U/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with magnesium millimoles per liter (mmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with protein grams per liter (g/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with albumin grams per liter (g/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with thyroid-stimulating hormon (TSH) milliunits per liter (mU/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with free thyroxin (fT3) picomole per liter (pmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with free thyroxin (fT4) picomole per liter (pmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with follicle stimulating hormone (FSH) international units per liter (IE/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with luteinizing hormone (LH) international units per liter (IE/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with morning cortisol level nanomoles per liter (nmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with fasting insulin millimoles per liter (pmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with leptin nanogram per milliliter (ng/ml).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with ghrelin picogram per milliliter (pg/ml).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with brain derived neurotrophic factor (BDNF) picogram per milliliter (pg/ml).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with cytokine (IL-6) picogram per milliliter (pg/ml).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with cytokine (IL-7) picogram per milliliter (pg/ml).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with estradiol picomole per liter (pmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with testosteron nanomoles per liter (nmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with free testosteron picomole per liter (pmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with progesteron nanomoles per liter (nmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with C-peptide nanomoles per liter (nmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with prolactin microgram per liter (µg/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with IGF-1 microgram per liter (µg/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with orexin picogram per milliliter (pg/ml).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with oxytocin (unit TBD).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with apodinectin (unit TBD).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with NF-L (unit TBD).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with GFAP (unit TBD).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with leptin receptor (unit TBD).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with TNF-Alpha (unit TBD).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Heart Frequency Variation (HFV) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Assessed with ECG and will be analysed with the software HRVTool in Matlab.
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Measured with Glucose millimoles per liter (mmol/l).
Measured: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start31 May 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anorexia NervosaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled, double-blind, randomized trial. The efficacy of metreleptin in Anorexia Nervosa patients will be tested against an inactive placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gabriella Milos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Gabriella Milos, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06305182
- Sponsor's protocol ID
- BASEC 2022-01328
- Acronym
- METRAN
- Status last verified
- Jul 2026
- First submitted
- 6 Feb 2024
- Last updated
- 29 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metreleptin in Anorexia Nervosa, Randomized Controlled Trial; Effects on Depressive Symptoms and Concomitant Changes in Brain Connectivity
- ClinicalTrials.gov ID
- NCT06305182
- Acronym / sponsor ID
- METRAN / BASEC 2022-01328
- Conditions
- Anorexia Nervosa
- Keywords
- Anorexia Nervosa, Leptin, Metreleptin, Weight gain, Depression
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Gabriella MilosUniversity, hospital or other
- Study start
- 31 May 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Anorexia nervosa (AN) mainly affects young people, especially young women. AN is one of the most lethal psychiatric disorders. Treatment often proves to be very difficult, and the course of AN is frequently chronic. Specific pharmacological therapies for AN are lacking. Recent studies have shown that metabolic alterations play a major role in the etiology and pathogenesis of AN. An important metabolic alteration involved in the etiology and pathogenesis of AN is the hormone leptin. Patients with AN show hypoleptinemia. The role of hypoleptinemia in the neuroendocrine adaptation to starvation seems to induce emotional, cognitive, and behavioral symptoms of AN. From a theoretical point of view, pharmacotherapy aimed at increasing leptin levels in patients with AN has great therapeutic potential. Recently, positive effects following the experimental administration of subcutaneous metreleptin have been observed in small number of young patients with severe AN. Importantly, no side effects have been observed. For all these reasons, the present study will investigate, using a double-blind design, the therapeutic effect of metreleptin in patients with AN. Metreleptin will be administrated to 50 inpatients with AN: 25 patients will receive verum and 25 will receive placebo for 14 days. The primary objectives of this study are the amelioration of mood and weight. Secondary objectives are the investigation of functional brain connectivity, AN symptoms, as well as hematological, blood chemistry and neuroendocrinological parameters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo-controlled, double-blind, randomized trial. The efficacy of metreleptin in Anorexia Nervosa patients will be tested against an inactive placebo.
| Arm | Type | Receives |
|---|---|---|
| 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 | Drug: Sodium chloride25 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). |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetreleptinAlso: Myalept®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. | Drug | – |
| Sodium chlorideThe 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. | Drug | Placebo-therapy |
Primary outcome
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
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
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.
Body weight status in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Body weight status will be indicated by weight in kilograms (kg).
62 secondary outcomes
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Autism symptoms assessed by the Autism-Spectrum Quotient-short version (AQ-k) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Patient's quality of life by items 1, 2, 5, 6, 7, 10, 17, 19, 20, and 22 from the WHO Quality of Life Questionnaire (WHOQOL-BREF) in the metreleptin-assisted therapy group compared to placebo-therapy between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Visual Analog Scale (VAS) about key Anorexia Nervosa and depression symptoms in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Social interaction by the Liebowitz Social Anxiety Scale (LSAS) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Anhedonia by the Snaith-Hamilton Pleasure Scale (SHAPS-D) in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Hematology in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Blood chemistry in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Neuroendocrinological blood parameters in the metreleptin-assisted therapy group compared to placebo-therapy group between Baseline, Post Treatment and 5 weeks Follow Up
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Metreleptin and Sodium chloride in people with Anorexia Nervosa, run by Gabriella Milos at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gabriella Milos, Prof. Dr. med. (0041 44 255 52 80, Gabriella.Milos@usz.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.