Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: HM15912 Active, Placebo.
- Who it may be relevant to
- Registry conditions: Short Bowel Syndrome. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Belgium, Denmark, France, Germany +3
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Multicenter, Proof-of-concept, Phase 2 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HM15912 (Sonefpeglutide) in Adult Subjects With Short Bowel Syndrome-associated Intestinal Failure (SBS-IF)
Overview
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(sonefpeglutide) in adult subjects with SBS-associated intestinal failure (SBS-IF).
Detailed 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.
Interventions
- Drug HM15912 Active
Randomized, double-blind, placebo-controlled - Drug Placebo
Randomized, double-blind, placebo-controlled
Primary outcome measures
- Incidence of adverse events (AEs) [Time frame: for 24 weeks]
Eligibility criteria
Inclusion criteria
- 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)
- Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol
- 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
- Any history of colon cancer.
- 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
- History of alcohol or drug abuse (within 1 year of screening)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
France · 4 centers
- Hopital Beaujon — Clichy
- Centre Hospitalier Universitaire de Bordeaux — Bordeaux
- Les Hospices Civils de Lyon — Lyon
- Centre Hospitalier Universitaire de Nice — Nice
United States · 2 centers
- Brigham & Women's Hospital — Boston
- The Cleveland Clinic Foundation — Cleveland
Germany · 2 centers
- Asklepios Klinik St. Georg — Hamburg
- Universitätsklinikum Tübingen — Tübingen
United Kingdom · 2 centers
- Salford Royal Hospital — Salford
- Central Middlesex Hospital — London
Belgium · 1 center
- UZ Leuven — Leuven
Denmark · 1 center
- Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Secti — Copenhagen
Poland · 1 center
- Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi — Lodz
South Korea · 1 center
- Samsung Medical Center — Seoul
Identifiers
NCT: NCT04775706 · HM-GLP2-201 · DOLPHINS-2