MedPath

Glepaglutide

Generic Name
Glepaglutide
Drug Type
Biotech
CAS Number
914009-86-2
Unique Ingredient Identifier
4M3C1913N6
Background

Glepaglutide is under investigation in clinical trial NCT00868660 (Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose).

The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome

Phase 3
Completed
Conditions
Short Bowel Syndrome
Interventions
First Posted Date
2021-08-05
Last Posted Date
2024-11-22
Lead Sponsor
Zealand Pharma
Target Recruit Count
12
Registration Number
NCT04991311
Locations
🇩🇰

Rigshospitalet, Copenhagen, Denmark

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS - Extension Trial

Phase 3
Conditions
Short Bowel Syndrome
Interventions
First Posted Date
2021-05-11
Last Posted Date
2023-11-27
Lead Sponsor
Zealand Pharma
Target Recruit Count
129
Registration Number
NCT04881825
Locations
🇩🇰

Rigshospitalet, Copenhagen, Denmark

🇩🇪

Charité - Universitätsmedizin Berlin, Berlin, Germany

🇩🇪

Universitätsklinikum Frankfurt, Frankfurt, Germany

and more 16 locations

A Bridging Trial to Compare the PK Profile When Glepaglutide is Administered Via Vial/Syringe Versus Autoinjector.

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2020-03-24
Last Posted Date
2021-07-14
Lead Sponsor
Zealand Pharma
Target Recruit Count
85
Registration Number
NCT04318743
Locations
🇳🇱

PRA Health Sciences- Location Martini, Groningen, NZ, Netherlands

Pharmacokinetic Profile of Glepaglutide After a Single Injection in Subjects With Varying Degrees of Renal Function

Phase 1
Completed
Conditions
Renal Impairment
Interventions
First Posted Date
2019-11-26
Last Posted Date
2020-11-18
Lead Sponsor
Zealand Pharma
Target Recruit Count
16
Registration Number
NCT04178447
Locations
🇵🇱

Specjalistyczne Centrum Medyczne - Prywatny Szpital, Kraków, Poland

🇭🇺

Fázis I-es Klinikai Farmakológiai, Budapest, Hungary

🇭🇺

Szent Imre Egyetemi Oktatókórház, Budapest, Hungary

Evaluation of Long Term Safety and Efficacy of Glepaglutide in Treatment of SBS

Phase 3
Recruiting
Conditions
Short Bowel Syndrome
Interventions
First Posted Date
2019-04-05
Last Posted Date
2023-11-27
Lead Sponsor
Zealand Pharma
Target Recruit Count
145
Registration Number
NCT03905707
Locations
🇬🇧

St Mark's Hospital, Harrow, United Kingdom

🇺🇸

Mayo Clinic College of Medicine, Rochester, Minnesota, United States

🇺🇸

Georgetown University Medical Center, Washington, District of Columbia, United States

and more 24 locations

Efficacy And Safety Evaluation of Glepaglutide in Treatment of Short Bowel Syndrome (SBS)

Phase 3
Completed
Conditions
Short Bowel Syndrome
Interventions
Drug: Placebo
First Posted Date
2018-10-01
Last Posted Date
2024-10-21
Lead Sponsor
Zealand Pharma
Target Recruit Count
106
Registration Number
NCT03690206
Locations
🇩🇪

Charité - Universitätsmedizin Berlin, Berlin, Germany

🇫🇷

Centre Hospitalier Lyon-Sud, Pierre-Bénite, France

🇺🇸

Georgetown University Medical Center, Washington, District of Columbia, United States

and more 26 locations

Trial to Evaluate the PK Profile of Glepaglutide (ZP1848) After a Single IV and After Multiple SC Injections in Healthy Subjects

Phase 1
Completed
Conditions
Healthy Subjects
Interventions
First Posted Date
2017-09-12
Last Posted Date
2017-12-22
Lead Sponsor
Zealand Pharma
Target Recruit Count
75
Registration Number
NCT03279302
Locations
🇺🇸

Covance CRU, Dallas, Texas, United States

A Phase 2 Trial Testing ZP1848 in Patients With SBS

Phase 2
Completed
Conditions
Short Bowel Syndrome
Interventions
First Posted Date
2016-02-24
Last Posted Date
2017-06-21
Lead Sponsor
Zealand Pharma
Target Recruit Count
18
Registration Number
NCT02690025
Locations
🇩🇰

Rigshospitalet, Copenhagen, Denmark

Healthy Normal Single Ascending Dose and Crohn's Patient Multiple Ascending Dose

Phase 1
Completed
Conditions
Inflammatory Bowel Disease
Interventions
First Posted Date
2009-03-25
Last Posted Date
2010-11-02
Lead Sponsor
Zealand Pharma
Target Recruit Count
66
Registration Number
NCT00868660
Locations
🇺🇸

CRI Worldwide, Willingboro, New Jersey, United States

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