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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Hanmi Pharmaceutical Company Limited
Study ID
NCT04775706
Phase
PHASE2
Status
Recruiting
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Conditions

  • Short Bowel Syndrome

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • HM15912 Active — DRUG
    Randomized, double-blind, placebo-controlled
  • Placebo — DRUG
    Randomized, double-blind, placebo-controlled

Study Details

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).

Key Dates

Start date
Mar 3, 2022
Status verified
Apr 2026
Primary completion
Dec 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
18 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active
  • Placebo Comparator: Matching Placebo

Primary Outcome Measure

Incidence of adverse events (AEs) [ Time Frame: for 24 weeks ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Brigham & Women's HospitalBostonMassachusetts02115-
The Cleveland Clinic FoundationClevelandOhio44195-

Find similar trials in Boston, MA

By research site
Brigham & Women's Hospital· Boston, MAThe Cleveland Clinic Foundation· Cleveland, OH

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