Livoletide ( DrugBank: Livoletide )


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7

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_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
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agemax
Inclusion_
gender
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size
PhaseCountries
1EUCTR2018-003062-13-FR
(EUCTR)
25/02/202021/11/2018A Clinical Study in patients with Prader-Willi-Syndrome (PWS) to test if a study drug named livoletide can reduce food related behaviour and be safe and well tolerated.A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR Prader-Willi Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
INN or Proposed INN: Livoletide
Millendo Therapeutics SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3United States;France;Canada;Belgium;Spain;Netherlands;United Kingdom;Italy
2EUCTR2018-003062-13-GB
(EUCTR)
11/07/201906/12/2018A Clinical Study in patients with Prader-Willi-Syndrome (PWS) to test if a study drug named livoletide can reduce food related behaviour and be safe and well tolerated.A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR Prader-Willi Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Millendo Therapeutics SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3France;United States;Belgium;Spain;Australia;Netherlands;United Kingdom
3EUCTR2018-003062-13-NL
(EUCTR)
10/07/201909/04/2019A Clinical Study in patients with Prader-Willi-Syndrome (PWS) to test if a study drug named livoletide can reduce food related behaviour and be safe and well tolerated.A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR Prader-Willi Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Millendo Therapeutics SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3France;United States;Belgium;Spain;Australia;Netherlands;United Kingdom
4EUCTR2018-003062-13-BE
(EUCTR)
07/06/201925/03/2019A Clinical Study in patients with Prader-Willi-Syndrome (PWS) to test if a study drug named livoletide can reduce food related behaviour and be safe and well tolerated.A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR Prader-Willi Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Millendo Therapeutics SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3France;United States;Spain;Belgium;Australia;Netherlands;United Kingdom
5NCT03790865
(ClinicalTrials.gov)
March 25, 201928/12/2018Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi SyndromeA Phase 2b/3 Study to Evaluate the Safety, Tolerability, and Effects of Livoletide (AZP-531), an Unacylated Ghrelin Analogue, on Food-related Behaviors in Patients With Prader-Willi SyndromePrader-Willi Syndrome;HyperphagiaDrug: Livoletide;Drug: PlaceboMillendo Therapeutics SASNULLTerminated4 Years65 YearsAll158Phase 2/Phase 3United States;Australia;Belgium;France;Italy;Netherlands;Spain;United Kingdom
6EUCTR2018-003062-13-IT
(EUCTR)
20/03/201907/10/2020A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR Prader-Willi Syndrome
MedDRA version: 20.0;Level: SOC;Classification code 10010331;Term: Congenital, familial and genetic disorders;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: D.3.2 Product code where applicable13:
Product Code: [AZP-531]
Millendo Therapeutics SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom;Italy
7EUCTR2018-003062-13-ES
(EUCTR)
20/03/201918/01/2019A Clinical Study in patients with Prader-Willi-Syndrome (PWS) to test if a study drug named livoletide can reduce food related behaviour and be safe and well tolerated.A Phase 2b/3 study to evaluate the safety, tolerability, and effects of livoletide (AZP-531), an unacylated ghrelin analog, on food-related behaviors in patients with Prader-Willi syndrome - ZEPHYR Prader-Willi Syndrome
MedDRA version: 20.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Product Name: Livoletide
Product Code: AZP-531
INN or Proposed INN: Livoletide
Millendo Therapeutics SASNULLNot RecruitingFemale: yes
Male: yes
150Phase 2;Phase 3France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom