HM15912 for Short Bowel Syndrome

Recruiting at 24 trial locations

Overseen By Wooyoung Hong

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Hanmi Pharmaceutical Company Limited

Disqualifiers: Colon cancer, Other cancers, Alcohol or drug abuse

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

18 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What is the purpose of this trial?

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).

Eligibility Criteria

Adults with Short Bowel Syndrome (SBS) who rely on parenteral nutrition or IV due to intestinal failure can join. They must have less than 200 cm of small bowel, stable for at least 6 months, and be able to consent. Those with a history of colon cancer, other cancers within the last 5 years (except certain skin cancers), or recent substance abuse cannot participate.

Inclusion Criteria

I am an adult with Short Bowel Syndrome causing intestinal failure.

I have short bowel syndrome, no recent surgeries, and stable IV nutrition needs.

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

Exclusion Criteria

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

I have been cancer-free for 5 years, except for certain skin or cervical cancers.

I have had colon cancer in the past.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Run-in

Participants undergo a run-in period to stabilize conditions before core treatment

2-4 weeks

Core Treatment

Participants receive SC administration of HM15912 or placebo for 6 months

24 weeks

Extension Treatment

Participants may continue treatment in an extension phase for an additional 7 months

28 weeks

Safety Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• HM15912 Active
• Placebo

Trial Overview The trial is testing HM15912 against a placebo in adults with SBS-associated intestinal failure. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real treatment versus placebo until after the results are collected.

Participant Groups

Group I: HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active Experimental Treatment 1 Intervention

Group II: Matching Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Hanmi Pharmaceutical Company Limited

Lead Sponsor

Trials

196

Recruited

62,100+

Young Choi

Hanmi Pharmaceutical Company Limited

Chief Medical Officer since 2023

PhD in Pharmacology from Yonsei University

Jae-Hyun Park

Hanmi Pharmaceutical Company Limited

Chief Executive Officer since 2024

MD from Seoul National University