A Phase 2 interventional study of Metreleptin and Sodium chloride in Anorexia Nervosa, sponsored by Gabriella Milos. Recruiting at 1 site in Switzerland. Open to participants aged 17 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-07-29.
Sponsored by Gabriella Milos · Phase 2, Interventional, and Treatment
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.
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.
469 studies on the registry are indexed under Anorexia Nervosa; 127 are open to participants now.
This study's planned enrollment of 50 is close to the median of 46 across 313 interventional studies indexed under Anorexia Nervosa.
Browse Anorexia Nervosa studies →This is the only study on the registry with Gabriella Milos as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Main key inclusion criteria:
Main key exclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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
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®
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.
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.
Time frame: 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).
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
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.
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
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.
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
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).
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
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).
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
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.
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
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.
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
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.
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
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).
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
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.
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
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.
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
Measured with hemoglobin grams per liter (g/l).
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
Measured with hematocrit liter per liter (l/l).
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
Measured with erythrocytes Tera per liter (T/l).
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
Measured with thrombocytes Giga per liter (G/l).
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
Measured with leucocytes Giga per liter (G/l).
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
Measured with Sodium millimoles per liter (mmol/l).
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
Measured with potassium millimoles per liter (mmol/l).
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
Measured with phosphate millimoles per liter (mmol/l).
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
Measured with creatinine micromoles per liter (µmol/l).
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
Measured with creatinine kinase Units per liter (U/l).
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
Measured with estimated Glomerular Filtration Rate (eGFR) milliliters per minute (ml/min).
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
Measured with bilirubin total micromoles per liter (µmol/l).
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
Measured with gamma-glutamyltranspeptidase Units per liter (U/l).
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
Measured with alanine aminotransferase Units per liter (U/l).
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
Measured with alkaline phosphatase Units per liter (U/l).
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
Measured with pancreatic amylase Units per liter (U/l).
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
Measured with lipase Units per liter (U/l).
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
Measured with C-reactive protein (CRP) milligrams per liter (mg/l).
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
Measured with calcium millimoles per liter (mmol/l).
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
Measured with chloride millimoles per liter (mmol/l).
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
Measured with aspartat-aminostransf. (GOT) Units per liter (U/l).
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
Measured with magnesium millimoles per liter (mmol/l).
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
Measured with protein grams per liter (g/l).
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
Measured with albumin grams per liter (g/l).
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
Measured with thyroid-stimulating hormon (TSH) milliunits per liter (mU/l).
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
Measured with free thyroxin (fT3) picomole per liter (pmol/l).
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
Measured with free thyroxin (fT4) picomole per liter (pmol/l).
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
Measured with follicle stimulating hormone (FSH) international units per liter (IE/l).
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
Measured with luteinizing hormone (LH) international units per liter (IE/l).
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
Measured with morning cortisol level nanomoles per liter (nmol/l).
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
Measured with fasting insulin millimoles per liter (pmol/l).
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
Measured with leptin nanogram per milliliter (ng/ml).
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
Measured with ghrelin picogram per milliliter (pg/ml).
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
Measured with brain derived neurotrophic factor (BDNF) picogram per milliliter (pg/ml).
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
Measured with cytokine (IL-6) picogram per milliliter (pg/ml).
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
Measured with cytokine (IL-7) picogram per milliliter (pg/ml).
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
Measured with estradiol picomole per liter (pmol/l).
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
Measured with testosteron nanomoles per liter (nmol/l).
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
Measured with free testosteron picomole per liter (pmol/l).
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
Measured with progesteron nanomoles per liter (nmol/l).
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
Measured with C-peptide nanomoles per liter (nmol/l).
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
Measured with prolactin microgram per liter (µg/l).
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
Measured with IGF-1 microgram per liter (µg/l).
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
Measured with orexin picogram per milliliter (pg/ml).
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
Measured with oxytocin (unit TBD).
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
Measured with apodinectin (unit TBD).
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
Measured with NF-L (unit TBD).
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
Measured with GFAP (unit TBD).
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
Measured with leptin receptor (unit TBD).
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
Measured with TNF-Alpha (unit TBD).
Time frame: 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.
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
Measured with Glucose millimoles per liter (mmol/l).
Time frame: Baseline (day -1), Post Treatment (day 14) and after 5 weeks Follow Up (day 49)
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