Phase 2 Study to Assess the Safety, PK, and PD of Sonefpeglutide (HM15912) in SBS-IF Subjects

NCT04775706 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: HM-GLP2-201DOLPHINS-2
• Study Type: interventional
• Target: 18
• Locations: 8 countries
• Sites: 14

Brief 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(sonefpeglutide) in adult subjects with SBS-associated intestinal failure (SBS-IF).

Conditions

Short Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events (AEs)

  after multiple subcutaneous (SC) doses

  for 24 weeks

Study Arms (2)

HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active

EXPERIMENTAL

Drug: HM15912 Active

Matching Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

HM15912 Active DRUG

Randomized, double-blind, placebo-controlled

HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active

Placebo DRUG

Randomized, double-blind, placebo-controlled

Matching Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hanmi Pharmaceutical Company Limited: lead

Study Sites (14)

Brigham & Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

RECRUITING

UZ Leuven

Leuven, Vlaams Brabant, 3000, Belgium

RECRUITING

Rigshospitalet Department of Digestive Diseases, Transplantation and General Surgery Section for Intestinal Failure

Copenhagen, 2100, Denmark

RECRUITING

Hopital Beaujon

Clichy, Clichy, 92110, France

RECRUITING

Centre Hospitalier Universitaire de Bordeaux

Bordeaux, 33000, France

RECRUITING

Les Hospices Civils de Lyon

Lyon, 69002, France

RECRUITING

Centre Hospitalier Universitaire de Nice

Nice, 06300, France

RECRUITING

Asklepios Klinik St. Georg

Hamburg, Free and Hanseatic City of Hamburg, 20099, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, Tübingen, 72076, Germany

RECRUITING

Wojewodzki Specjalistyczny Szpital im. Mikołaja Pirogowa w Łodzi

Lodz, Łódź Voivodeship, 90-531, Poland

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Salford Royal Hospital

Salford, Greater Manchester, M6 8HD, United Kingdom

RECRUITING

Central Middlesex Hospital

London, NW10 7NS, United Kingdom

RECRUITING

MeSH Terms

Conditions

Short Bowel Syndrome

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Wooyoung Amy Hong

CONTACT

+82 2 410 9238; wooyoung.hong@hanmi.co.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2021
• First Posted: March 1, 2021
• Study Start: March 3, 2022
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): May 1, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

BE (1); PL (1); DE (2); DK (1); KR (1); US (2); FR (4); GB (2)