AZP-531 ( DrugBank: - )


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10

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
Inclusion_
agemax
Inclusion_
gender
Target_
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-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
7EUCTR2018-003062-13-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
8EUCTR2014-001670-34-FR
(EUCTR)
01/10/201524/06/2015A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi SyndromeA Phase IIa, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and effects of AZP-531, an Unacylated Ghrelin analog, on food-related behavior in patients with Prader-Willi Syndrome Prader-Willi Syndrome
MedDRA version: 18.0;Level: HLGT;Classification code 10003018;Term: Appetite and general nutritional disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0;Level: HLT;Classification code 10003022;Term: Appetite disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: AZP-531
Product Code: AZP-531
INN or Proposed INN: INN Not yet proposed
Alize PharmaNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Spain;Italy
9EUCTR2014-001670-34-IT
(EUCTR)
31/08/201508/07/2015A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi SyndromeA Phase IIa, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and effects of AZP-531, an Unacylated Ghrelin analog, on food-related behavior in patients with Prader-Willi Syndrome Prader-Willi Syndrome
MedDRA version: 18.0;Level: HLGT;Classification code 10003018;Term: Appetite and general nutritional disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 18.0;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 18.0;Level: HLT;Classification code 10003022;Term: Appetite disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: AZP-531
Product Code: AZP-531
INN or Proposed INN: INN Not yet proposed
Alize PharmaNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Spain;Italy
10EUCTR2014-001670-34-ES
(EUCTR)
26/01/201524/10/2014A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi SyndromeA Phase IIa, randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety, tolerability, and effects of AZP-531, an Unacylated Ghrelin analog, on food-related behavior in patients with Prader-Willi Syndrome Prader-Willi Syndrome
MedDRA version: 17.1;Level: HLGT;Classification code 10003018;Term: Appetite and general nutritional disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders
MedDRA version: 17.1;Level: PT;Classification code 10036476;Term: Prader-Willi syndrome;System Organ Class: 10010331 - Congenital, familial and genetic disorders
MedDRA version: 17.1;Level: HLT;Classification code 10003022;Term: Appetite disorders;System Organ Class: 10027433 - Metabolism and nutrition disorders;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Product Name: AZP-531
Product Code: AZP-531
INN or Proposed INN: INN Not yet proposed
Alize PharmaNULLNot RecruitingFemale: yes
Male: yes
40Phase 2France;Spain;Italy