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HM15912 for Short Bowel Syndrome

Phase 2
Research Sponsored by Hanmi Pharmaceutical Company Limited
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Men or women, aged 18 years of age or older with Short Bowel Syndrome (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)
Be older than 18 years old
Screening 3 weeks
Treatment Varies
Follow Up for 24 weeks
Awards & highlights

Study Summary

This trial will test a new drug for safety, how it is processed by the body, and how it affects people with a specific intestinal disorder.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
While specific side effects aren't listed here, typical ones may include reactions at injection sites, gastrointestinal symptoms, potential allergic responses, and changes in blood tests that monitor organ function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
I am an adult with Short Bowel Syndrome causing intestinal failure.


Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~for 24 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and for 24 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of adverse events (AEs)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg ActiveExperimental Treatment1 Intervention
Group II: Matching PlaceboPlacebo Group1 Intervention

Find a Location

Who is running the clinical trial?

Hanmi Pharmaceutical Company LimitedLead Sponsor
190 Previous Clinical Trials
61,088 Total Patients Enrolled

Media Library

HM15912 Active (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04775706 — Phase 2
Short Bowel Syndrome Research Study Groups: HM15912 0.5 mg/kg, 1.0mg/kg, 1.5mg/kg Active, Matching Placebo
Short Bowel Syndrome Clinical Trial 2023: HM15912 Active Highlights & Side Effects. Trial Name: NCT04775706 — Phase 2
HM15912 Active (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04775706 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients still being accepted for this experiment?

"That is correct, the online information does show that this study is still recruiting individuals. The original posting date was March 3rd, 2022 with the most recent edit on November 3rd of the same year. There are 5 locations where a total of 18 patients will be enrolled."

Answered by AI

What is the standing of HM15912 with the FDA?

"The safety of HM15912 Active is a 2. This is because, although there is supporting data for its safety, none of it speaks to the efficacy of the medication."

Answered by AI

Are there many places in the US where this research is taking place?

"Presently, this study is looking for individuals to enroll from 5 sites. 3 of these locations are in New york, Atlanta and Columbia with the other 2 still yet to be determined. If you are considering participating, try and select a location close to reduce travel time commitments."

Answered by AI

Is there a limit to the amount of people who can join this trial?

"According to the information on clinicaltrials.gov, this trial is recruiting patients as we speak. The posting date was March 3rd, 2022 and it has been updated November 3rd, 2022. They are looking for 18 individuals total from 5 separate locations."

Answered by AI
~7 spots leftby Dec 2025