HM15912 for Short Bowel Syndrome

Recruiting at 26 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HM15912 for individuals with short bowel syndrome (SBS) who require assistance absorbing nutrients due to intestinal failure. The trial aims to assess the safety and effectiveness of this treatment when injected under the skin. Participants will receive either HM15912 at varying doses or a placebo, which contains no active ingredients. Ideal candidates will have stable SBS, rely on intravenous nutrition, and have no plans for additional surgery. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in SBS treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that HM15912 has been safe in earlier studies. In a study with healthy participants, HM15912 was well-tolerated, with no serious side effects reported. The treatment remains active in the body for over 100 hours.

An independent committee regularly reviews safety information to ensure the treatment remains safe during trials. While this doesn't guarantee the absence of side effects, it demonstrates ongoing monitoring for participant safety. So far, evidence suggests that HM15912 is relatively safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Short Bowel Syndrome, such as parenteral nutrition and medications like teduglutide, HM15912 is unique because it targets the body's ability to adapt and absorb nutrients more effectively. This investigational treatment, administered in varying doses, is designed to enhance gut adaptation by potentially stimulating the growth of intestinal tissue. Researchers are particularly excited about HM15912 as it offers the possibility of reducing the dependence on intravenous nutrition, improving patients' quality of life significantly.

What evidence suggests that HM15912 might be an effective treatment for short bowel syndrome?

Research has shown that HM15912, a new long-lasting treatment, holds promise for short bowel syndrome (SBS). In animal studies, HM15912 helped the intestines grow and absorb nutrients better, addressing major challenges in SBS. Early human studies also demonstrated that HM15912 remains in the body longer, potentially increasing its effectiveness. This trial will test different dosages of HM15912 to evaluate its effectiveness in improving nutrient absorption for people with SBS. ^{1 3 4 5 6}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0022356524003963

HM15912, a Novel Long-Acting Glucagon-Like Peptide-2 ... HM15912, a Novel Long-Acting Glucagon-Like Peptide-2 Analog, Improves Intestinal Growth and Absorption Capacity in a Male Rat Model of Short Bowel Syndrome.

2. clinicalnutritionespen.com clinicalnutritionespen.com/article/S2405-4577(22)01052-X/fulltext

An Ongoing Phase 2 Study Of Hm15912, A Novel Long ... In first-in-human study, HM15912 showed improved pharmacokinetic profile - over 100 hours of half-life - and tolerable safety profile in healthy subjects.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36410792/

HM15912, a Novel Long-Acting Glucagon-Like Peptide-2 ... HM15912, a Novel Long-Acting Glucagon-Like Peptide-2 Analog, Improves Intestinal Growth and Absorption Capacity in a Male Rat Model of Short ...

4. hanmipharm.com hanmipharm.com/science-pdf/HM15912/2022_ESPEN_Poster1_HM15912.pdf

an ongoing phase 2 study of hm15912, a novel long-acting ... Factors associated with response to teduglutide in patients with short-bowel syndrome and intestinal failure. Gastroenterology, 2018, 154.4: 874-885. REFERENCE.

5. clinicaltrials.eu clinicaltrials.eu/trial/study-of-hm15912-for-adults-with-short-bowel-syndrome-associated-intestinal-failure/

Study of HM15912 for Adults with Short Bowel Syndrome- ... This clinical trial investigates the efficacy and safety of HM15912, a glucagon-like peptide-2 analogue, in treating adults with Short Bowel ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04775706

NCT04775706 | Phase 2 Study to Assess the Safety, PK ... 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( ...