Beloranib ( DrugBank: Beloranib )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
193プラダー・ウィリ症候群6

193. プラダー・ウィリ症候群


臨床試験数 : 113 薬物数 : 111 - (DrugBank : 26) / 標的遺伝子数 : 48 - 標的パスウェイ数 : 102
No.TrialIDDate_
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PhaseCountries
1EUCTR2015-000660-33-BE
(EUCTR)
21/03/201617/08/2015A clinical trial to study the efficacy and safety of an investigational medication, beloranib, in treatment of food-related behaviour and weight in obese individuals with Prader-Willi Syndrome by comparison with placeboRandomized, Double-Blind, Placebo Controlled, Phase 3 Trial of Beloranib in Obese Subjects with Prader-Willi Syndrome to Evaluate Food-related Behavior, Total Body Weight, and Safety Over 52 Weeks - bestPWS|EU Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome
MedDRA version: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Subcutaneous Beloranib in Suspension
Product Code: ZGN-440
INN or Proposed INN: Beloranib
Other descriptive name: Beloranib
Zafgen Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;Spain;Belgium;Denmark;Germany;Italy;United Kingdom;Sweden
2EUCTR2015-000660-33-FR
(EUCTR)
29/10/201504/12/2015A clinical trial to study the efficacy and safety of an investigational medication, beloranib, in treatment of food-related behaviour and weight in obese individuals with Prader-Willi Syndrome by comparison with placeboRandomized, Double-Blind, Placebo Controlled, Phase 3 Trial of Beloranib in Obese Subjects with Prader-Willi Syndrome to Evaluate Food-related Behavior, Total Body Weight, and Safety Over 52 Weeks - bestPWS|EU Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome
MedDRA version: 18.1;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders ;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Subcutaneous Beloranib in Suspension
Product Code: ZGN-440
INN or Proposed INN: Beloranib
Other descriptive name: Beloranib
Zafgen Inc.NULLNot Recruiting Female: yes
Male: yes
150 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noFrance;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
3EUCTR2015-000660-33-SE
(EUCTR)
30/09/201511/08/2015A clinical trial to study the efficacy and safety of an investigational medication, beloranib, in treatment of food-related behaviour and weight in obese individuals with Prader-Willi Syndrome by comparison with placeboRandomized, Double-Blind, Placebo Controlled, Phase 3 Trial of Beloranib in Obese Subjects with Prader-Willi Syndrome to Evaluate Food-related Behavior, Total Body Weight, and Safety Over 52 Weeks - bestPWS II Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome
MedDRA version: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Subcutaneous Beloranib in Suspension
Product Code: ZGN-440
INN or Proposed INN: Beloranib
Other descriptive name: Beloranib
Zafgen Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;United States;Canada;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
4EUCTR2015-000660-33-ES
(EUCTR)
12/08/201513/08/2015A clinical trial to study the efficacy and safety of an investigational medication, beloranib, in treatment of food-related behaviour and weight in obese individuals with Prader-Willi Syndrome by comparison with placeboRandomized, Double-Blind, Placebo Controlled, Phase 3 Trial of Beloranib in Obese Subjects with Prader-Willi Syndrome to Evaluate Food-related Behavior, Total Body Weight, and Safety Over 52 Weeks - bestPWS|EU Improvement of Hyperphagia and related behaviors as well as Body Composition/Overweight in Prader-Willi-Syndrome
MedDRA version: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Subcutaneous Beloranib in Suspension
Product Code: ZGN-440
INN or Proposed INN: Beloranib
Other descriptive name: Beloranib
Zafgen Inc.NULLNot RecruitingFemale: yes
Male: yes
150Phase 3France;Belgium;Spain;Denmark;Germany;Italy;United Kingdom;Sweden
5NCT02179151
(ClinicalTrials.gov)
September 201425/6/2014Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Beloranib) in Obese Subjects With Prader-Willi SyndromeRandomized, Double-Blind, Placebo Controlled, Phase 3 Trial of ZGN-440 (Subcutaneous Beloranib in Suspension) in Obese Subjects With Prader-Willi Syndrome to Evaluate Total Body Weight, Food-related Behavior, and Safety Over 6 MonthsPrader-Willi Syndrome;ObesityDrug: ZGN-440 for Injectable Suspension;Drug: ZGN-440 Placebo for Injectable SuspensionZafgen, Inc.NULLTerminated12 Years65 YearsAll108Phase 3United States
6NCT01818921
(ClinicalTrials.gov)
June 201321/3/2013An Efficacy, Safety, and Pharmacokinetics Study of Beloranib in Obese Subjects With Prader-Willi SyndromeRandomized, Double-Blind, Placebo Controlled, Parallel Dose Ranging Phase 2a Trial of ZGN-440 (Subcutaneous Beloranib in Suspension), A Novel Methionine Aminopeptidase 2 Inhibitor, in Over-weight and Obese Subjects With Prader-Willi Syndrome to Evaluate Weight Reduction, Food-related Behavior, Safety, and Pharmacokinetics Over 4 Weeks Followed by Optional 4-Week Open-Label ExtensionObesity;Over-weight;Prader-Willi SyndromeDrug: ZGN-440 sterile diluent;Drug: 1.2 mg ZGN-440 for injectable suspension;Drug: 1.8 mg ZGN-440 for injectable suspensionZafgen, Inc.NULLCompleted16 Years65 YearsBoth17Phase 2United States