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

NCT04775706 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2026-04-28

No results posted yet for this study

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

Interventions

DRUG

HM15912 Active

Randomized, double-blind, placebo-controlled

DRUG

Placebo

Randomized, double-blind, placebo-controlled

Sponsors & Collaborators

  • Hanmi Pharmaceutical Company Limited

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-03
Primary Completion
2027-12-31
Completion
2028-05-31
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Denmark
  • France
  • Germany
  • Poland
  • South Korea
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04775706 on ClinicalTrials.gov