Phase 2 Study to Assess the Safety, PK, and PD in SBS-IF Subjects

Short Bowel Syndrome Clinical Trial

Official title:

A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04775706
• Other study ID #: HM-GLP2-201
• Secondary ID: DOLPHINS-2
• Status: Recruiting
• Phase: Phase 2
• Start date: March 3, 2022
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: Hanmi Pharmaceutical Company Limited
• Contact: Wooyoung Hong
• Phone: +82 2 410 9238
• Email: wooyoung.hong[@]hanmi.co.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a randomized, double-blind, placebo-controlled, proof-of-concept (PoC), Phase 2 study to assess the safety, PK, and PD of SC administration of HM15912 in adult subjects with SBS-associated intestinal failure (SBS-IF).

Description:

The study consists of a screening period, a run-in period, a 6-months core treatment period, a 7-months extension treatment period and a 1-month safety follow-up period.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Men or women, aged 18 years of age or older with SBS resulting in intestinal failure at the time of signing the informed consent form (ICF) (or country's legal age of majority if the legal age is <18 years)

2. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol

3. Diagnosis of SBS with the latest intestinal resection being at least 6 months prior to Screening and considered stable regarding the PN/IV need. No restorative surgery planned in the study period.

Exclusion Criteria:

1. Any history of colon cancer.

2. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free for at least 5 years

3. History of alcohol or drug abuse (within 1 year of screening)

Related Conditions & MeSH terms

• Short Bowel Syndrome
• Syndrome

Intervention

Drug:
• HM15912 Active
Randomized, double-blind, placebo-controlled
• Placebo
Randomized, double-blind, placebo-controlled

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams Brabant
Denmark	Aalborg Universitetshospital	Aalborg	Region Nordjylland
Denmark	Copenhagen University Hospital	Copenhagen	Region Hovedstaden
France	Centre Hospitalier Universitaire de Bordeaux	Bordeaux
France	Hopital Beaujon	Clichy
France	Les Hospices Civils de Lyon	Lyon
France	Centre Hospitalier Universitaire de Nice	Nice
Germany	Asklepios Klinik St. Georg	Hamburg
Germany	Universitätsklinikum Tübingen	Tübingen
Korea, Republic of	Samsung Medical Center	Seoul
Poland	Medicome Sp. z o.o.	Oswiecim
Poland	Uniwersytecki Szpital Kliniczny	Poznan	Poznan
United States	University of Illinois Hospital & Health Sciences System (UI Health)	Chicago	Illinois
United States	The Cleveland Clinic Foundation	Cleveland	Ohio
United States	Mount Sinai School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  France,  Germany,  Korea, Republic of,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs)	after multiple subcutaneous (SC) doses	for 24 weeks