Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

165

Participants

Timeline

Start Date

June 7, 2023

Primary Completion Date

November 15, 2024

Study Completion Date

June 16, 2027

Conditions
Chronic HypoparathyroidismEndocrine System DiseasesParathyroid Diseases
Interventions
COMBINATION_PRODUCT

eneboparatide

Supplied as a solution (concentration of 250 mcg/mL or 500 mcg/mL) in single-patient-use prefilled pens

COMBINATION_PRODUCT

Placebo

Placebo is supplied as a solution (containing the excipient solution for eneboparatide) in single-patient-use prefilled pens

Trial Locations (54)

1083

Semmelweis Egyetem Belgyogyaszati es Hematologiai Klinika, Budapest

2333

Leiden University Medical Center, Leiden

7624

Pecsi Tudomanyegyetem, Pécs

8200

Aarhaus University Hospital, Aarhus

10032

Colombia University Irving Medical Center, New York

13385

Hopital de la Conception-APHM, Marseille

15006

Complejo Hospitalario Universitario de A Coruna, A Coruña

19104

The Children's Hospital of Philadelphia (CHOP), Philadelphia

The Children's Hospital of Philadephia, Philadelphia

19107

Thomas Jefferson University, Philadelphia

20122

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano, Milan

27834

Physician's East Endocrinology, Greenville

31008

Clinica Universidad de Navarra, Pamplona

40138

Azienda Ospedaliero Universitaria de Bologna, Policlinico Sant Orsola Malpighi, Bologna

41013

Hospital Universitario Virgen del Rocio, Seville

43210

The Ohio State University Wexner Medical Center, Columbus

44093

CHU de Nantes - Hôtel-Dieu, Nantes

46202

Indiana University (IU) Health University Hospital, Indianapolis

50134

Azienda Ospedaliera Universitaria Careggi, Florence

55905

Mayo Clinic, Rochester

56124

Azienda Ospedaliera Universitaria Pisana-Ospedale di Cisanello, Pisa

60201

North Shore University Health System, Evanston

60637

University of Chicago - Medical Center, Chicago

79935

Academy of Diabetes, Thyroid and Endocrine, El Paso

80113

Denver Endocrinology Diabetes and Thyroid Center, Denver

81667

Medicover Neuroendokrinologie MVZ, Munich

89511

Northern Nevada Endocrinology, Reno

90502

Harbor UCLA Medical Center Endocrinology, Torrance

94275

Hospital Bicetre AP-HP, Paris

97080

Universitaetsklinikum Wuerzburg, Würzburg

99204

Arthritis Northwest, PLLC, Spokane

02114

Massachusetts General Hospital, Boston

A1B 3V6

Eastern Regional Health Authority Health Sciences Centre, St. John's

L6M 1M1

Bone Research and Education Center, Oakville

G1V 4G2

CHU de Quebec Research Centre, Québec

Unknown

Rigshospitalet, Copenhagen

Teikyo University Chiba Medical Center, Chiba

Kanazawa University Hospital, Kanazawa

Osaka City Hospital, Osaka

Osaka Metropolital University Hospital, Osaka

Tokushima University Hospital, Tokushima

Tottori University Hospital, Tottori

01307

Universitatsklinikum Carl Gustav Carus an der TU Dresden, Dresden

00128

Via Alvaro del Portillo, 200, Roma, Italy 00128, Roma

3015 GD

Eramus MC - University Medical Center, Rotterdam

30-688

Medycyny Nuklearnej i Chorob Wewnetrznych, Krakow

93-338

Instytut Centrum Zdrowia Matki Polki. Klinika Endokrynologii Chorob Metabolicznych, Lodz

00189

Cendrum Zdrowi MDM - EB Group Sp., Warsaw

1500-650

Hospital da Luz Lisboa, Lisbon

4434-502

Centro Hospital Vila Nova de Faia/Espinho, Porto

08035

Hospital Universitari Vall d'Hebron, Barcelona

LE1 5WW

University Hospitals of Leicester NHS Trust, Leicester

NR4 7UQ

Norfolk & Norwich University NHS Foundation Trust, Quadrum Institute, Norwich

OX3 7LE

Churchill Hospital, Oxford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Amolyt Pharma

INDUSTRY

lead

Alexion Pharmaceuticals, Inc.

INDUSTRY

NCT05778071 - Evaluation of the Safety and Efficacy of Eneboparatide (AZP-3601) in Patients With Chronic Hypoparathyroidism | Biotech Hunter | Biotech Hunter