DDrare: Database of Drug Development for Rare Diseases

Searched query = "Prader-Willi syndrome"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 1.2 mg ZGN-440 for injectable suspension; 1.8 mg ZGN-440 for injectable suspension; ACOMPLIA 20 mg film-coated tablets; ACTH; AZP-531; Acetylcysteine; Acomplia; Air; Anastrozole; B. lactis B94; Beloranib; Byetta; CBDV; CBDV Compound; Cannabidiol; Cannabidiol Oral Solution; Carbetocin; Chloride; Choline; Coenzyme Q10; D.3.2 Product code where applicable13:; DCCR; DIAZOXIDE CHOLINE; Diazoxide; Diazoxide choline; Diazoxide choline controlled-release tablet; EU/1/06/362/003: 5µg (1 pen); Eutropin; Exenatide; FE 992097; Fluimucil; Fluimucil (acetylcysteine); GENOTONORM; GENOTROPIN (Somatropin) is a growth hormone treatment. It is an exact copy of the natural growth hormone that our bodies make. The main difference is that GENOTROPIN is man-made.; GLWL-01; Genotonorm; Genotonorm Miniquick 0,2 mg; Genotropin; Growth hormone; Growth hormone (Genotonorm® or Omnitrope®); Guanfacine; Guanfacine extended release (GXR); Human growth hormone; Humatrope 6 mg/12 mg/24 mg injektiokuiva-aine ja liuotin, liuosta varten; INN Not yet proposed; Intranasal Oxytocin (IN-OXT); Intranasal carbetocin Dose 1; Intranasal carbetocin Dose 2; Intranasal oxytocin; LIRAGLUTIDE; Liraglutide; Livoletide; METOPROLOL SUCCINATE; Medical Air vs Oxygen; Medical air; Metoprolol; Metoprololsuccinat Orion 25mg; Metoprololsuccinat ”Orion” 25mg; Metyrapone; Norditropin SimpleXx; Nutropin AQ; OMNITROPE; OT; OXYTOCIN; Octreotide; Omnitrope; Other: Control; Other: Low dose (1 mcg) ACTH stimulation test; Other: Overnight metyrapone test; Oxygen; Oxytocin; Oxytocin (OXT) continuous; Physiological serum (Sodium chloride); Pitolisant; Pitolisant oral tablets; Probiotic; Procedure: DEXA, blood tests, H.G.P.O, osseous age.; Procedure: biopsy; R05CB01; RECOMBINANT HUMAN GROWTH HORMON; RECOMBINANT HUMAN GROWTH HORMONE; RM-493; Recombinant Human Growth Hormone (rhGH) Injection; Recombinant Somatropin; Recombinant human growth hormone; RhGH; Rimonabant; SOMATROPIN; Sandostatin LAR; Saxenda; Sodium chloride; Somatropin; Subcutaneous Beloranib in Suspension; Syntocinon; Syntocinon nasal spray; Syntocinon®/- Spray; TESOFENSINE; Tesofensine; Tesofensine/Metoprolol; Topiramate; ZGN-440; ZGN-440 for Injectable Suspension; ZGN-440 sterile diluent; [AZP-531]

No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
1	EUCTR2018-003062-13-FR (EUCTR)	25/02/2020	21/11/2018	A 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 SAS	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2;Phase 3	United States;France;Canada;Belgium;Spain;Netherlands;United Kingdom;Italy
2	EUCTR2018-003062-13-GB (EUCTR)	11/07/2019	06/12/2018	A 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 SAS	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2;Phase 3	France;United States;Belgium;Spain;Australia;Netherlands;United Kingdom
3	EUCTR2018-003062-13-NL (EUCTR)	10/07/2019	09/04/2019	A 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 SAS	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2;Phase 3	France;United States;Belgium;Spain;Australia;Netherlands;United Kingdom
4	EUCTR2018-003062-13-BE (EUCTR)	07/06/2019	25/03/2019	A 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 SAS	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2;Phase 3	France;United States;Spain;Belgium;Australia;Netherlands;United Kingdom
5	NCT03790865 (ClinicalTrials.gov)	March 26, 2019	28/12/2018	Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome	A 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 Syndrome	Prader-Willi Syndrome;Hyperphagia	Drug: Livoletide;Drug: Placebo	Millendo Therapeutics SAS	NULL	Terminated	4 Years	65 Years	All	158	Phase 2;Phase 3	United States;Australia;Belgium;France;Italy;Netherlands;Spain;United Kingdom
No.	TrialID	Date_ enrollment	Date_ registration	Public_title	Scientific_title	Condition	Intervention	Primary_ sponsor	Secondary_ sponsor	Recruitment_ Status	Inclusion_ agemin	Inclusion_ agemax	Inclusion_ gender	Target_ size	Phase	Countries
6	EUCTR2018-003062-13-IT (EUCTR)	20/03/2019	07/10/2020	A 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: 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 SAS	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	150	Phase 2	France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom;Italy
7	EUCTR2018-003062-13-ES (EUCTR)	20/03/2019	18/01/2019	A 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 SAS	NULL	Not Recruiting			Female: yes Male: yes	150	Phase 2;Phase 3	France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom
8	EUCTR2014-001670-34-FR (EUCTR)	01/10/2015	24/06/2015	A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi Syndrome	A 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 Pharma	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;Spain;Italy
9	EUCTR2014-001670-34-IT (EUCTR)	31/08/2015	08/07/2015	A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi Syndrome	A 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 Pharma	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2a	France;Spain;Italy
10	EUCTR2014-001670-34-ES (EUCTR)	26/01/2015	24/10/2014	A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi Syndrome	A 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 Pharma	NULL	Not Recruiting			Female: yes Male: yes	40	Phase 2	France;Spain;Italy

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-003062-13-FR
(EUCTR)

25/02/2020

21/11/2018

A 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 SAS

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2;Phase 3

United States;France;Canada;Belgium;Spain;Netherlands;United Kingdom;Italy

EUCTR2018-003062-13-GB
(EUCTR)

11/07/2019

06/12/2018

A 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

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 SAS

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2;Phase 3

France;United States;Belgium;Spain;Australia;Netherlands;United Kingdom

EUCTR2018-003062-13-NL
(EUCTR)

10/07/2019

09/04/2019

A 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

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 SAS

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2;Phase 3

France;United States;Belgium;Spain;Australia;Netherlands;United Kingdom

EUCTR2018-003062-13-BE
(EUCTR)

07/06/2019

25/03/2019

A 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

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 SAS

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2;Phase 3

France;United States;Spain;Belgium;Australia;Netherlands;United Kingdom

NCT03790865
(ClinicalTrials.gov)

March 26, 2019

28/12/2018

Effects of Livoletide (AZP-531) on Food-related Behaviors in Patients With Prader-Willi Syndrome

A 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 Syndrome

Prader-Willi Syndrome;Hyperphagia

Drug: Livoletide;Drug: Placebo

Millendo Therapeutics SAS

NULL

Terminated

4 Years

65 Years

All

158

Phase 2;Phase 3

United States;Australia;Belgium;France;Italy;Netherlands;Spain;United Kingdom

No.

TrialID

Date_
enrollment

Date_
registration

Public_title

Scientific_title

Condition

Intervention

Primary_
sponsor

Secondary_
sponsor

Recruitment_
Status

Inclusion_
agemin

Inclusion_
agemax

Inclusion_
gender

Target_
size

Phase

Countries

EUCTR2018-003062-13-IT
(EUCTR)

20/03/2019

07/10/2020

A 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: 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 SAS

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

150

Phase 2

France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom;Italy

EUCTR2018-003062-13-ES
(EUCTR)

20/03/2019

18/01/2019

A 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

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 SAS

NULL

Not Recruiting

Female: yes
Male: yes

150

Phase 2;Phase 3

France;United States;Canada;Belgium;Spain;Netherlands;United Kingdom

EUCTR2014-001670-34-FR
(EUCTR)

01/10/2015

24/06/2015

A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi Syndrome

A 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 Pharma

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Spain;Italy

EUCTR2014-001670-34-IT
(EUCTR)

31/08/2015

08/07/2015

A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 on food-related behavior in patients with Prader-Willi Syndrome

Product Name: AZP-531
Product Code: AZP-531
INN or Proposed INN: INN Not yet proposed

Alize Pharma

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2a

France;Spain;Italy

EUCTR2014-001670-34-ES
(EUCTR)

26/01/2015

24/10/2014

A Phase IIa study to evaluate the safety, tolerability, and effects of AZP-531 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 Pharma

NULL

Not Recruiting

Female: yes
Male: yes

Phase 2

France;Spain;Italy