Glepaglutide for Short Bowel Syndrome

(EASE SBS 6 Trial)

Enrolling by invitation at 15 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Zealand Pharma

Must be taking: Glepaglutide

Must not be taking: GLP-1, GLP-2, HGH, DPP-4

Disqualifiers: Pregnancy, Hypersensitivity, Major protocol deviations, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: Unknown

Duration: 104 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of a medication called glepaglutide for individuals with short bowel syndrome (SBS). Short bowel syndrome occurs when the body can't absorb enough nutrients due to a missing or malfunctioning part of the small intestine. Participants who used glepaglutide in previous studies can continue their treatment in this new phase to assess its long-term safety and effectiveness. This trial suits those who have been on glepaglutide treatment for at least six months in earlier studies and wish to continue. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of this treatment for others.

Do I have to stop taking my current medications for the trial?

The trial requires that you do not use certain medications like GLP-1, GLP-2, HGH, DPP-4 inhibitors, and somatostatin. If you are taking these, you may need to stop. However, prior use of glepaglutide is allowed.

Is there any evidence suggesting that glepaglutide is likely to be safe for humans?

Research has shown that glepaglutide is generally safe and well-tolerated for people with short bowel syndrome (SBS). In one study, participants taking glepaglutide reported more side effects than those taking a placebo, yet the treatment remained safe and tolerable. Most side effects were mild and not serious. This suggests that glepaglutide could be a promising treatment option for those with SBS, with manageable safety concerns. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for short bowel syndrome?

Glepaglutide is unique because it offers a new approach for treating Short Bowel Syndrome (SBS). Unlike standard treatments that often rely on dietary adjustments and intravenous feeding to manage symptoms, Glepaglutide is a GLP-2 analog that works by stimulating intestinal growth and enhancing nutrient absorption. Researchers are excited about this treatment because it targets the underlying cause of SBS by promoting intestinal adaptation, potentially reducing the need for long-term parenteral nutrition. This could significantly improve the quality of life for individuals with SBS by allowing for more normal food intake and reducing dependence on external nutritional support.

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

Studies have shown that glepaglutide, the treatment under study in this trial for short bowel syndrome (SBS), can significantly benefit patients. Research indicates it reduces the need for parenteral support, which is nutrition given through an IV. As a result, patients might require less IV nutrition and could gain more dietary independence. Previous findings suggest that patients tolerate glepaglutide well, which is encouraging. Overall, the evidence supports its effectiveness in improving the condition of those with SBS. ^{3 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with Short Bowel Syndrome (SBS) who were part of previous EASE SBS trials. They must have completed at least 6 months of glepaglutide treatment and agree to follow the study rules. People can't join if they're allergic to glepaglutide, had issues in past trials, are at risk due to other health problems, work for the sponsor or investigator, use certain gut-related drugs, stopped glepaglutide due to side effects before, or women who could get pregnant without contraception.

Inclusion Criteria

Has provided signed informed consent and agrees to comply with protocol requirements

Is being actively treated in the EASE SBS 3 trial

I have been on glepaglutide for at least 6 months in the EASE SBS 2 trial.

Exclusion Criteria

Has a known or suspected hypersensitivity to glepaglutide or related products

Had major protocol deviation(s) in the EASE SBS 2 or EASE SBS 3 trial that would affect the conduct of the present trial

Has a condition, disease, or circumstance that, in the opinion of the investigator, would put the patient at any undue risk, prevent completion of the trial, or confound the planned assessments of the trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants continue their glepaglutide treatment for 104 weeks

104 weeks

Regular visits for ECG, vital sign checks, colonoscopies, blood and urine tests, and physical exams

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Glepaglutide

Trial Overview

The trial tests the safety and effectiveness of a drug called Glepaglutide (10 mg dose), given twice weekly over two years to people with SBS. It's an extension for those already receiving it in prior studies. Participants will be monitored through heart tests, vital signs checks, colonoscopies, blood and urine tests, and physical exams.

How Is the Trial Designed?

Group I: Open-label Glepaglutide Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Zealand Pharma

Lead Sponsor

Trials

41

Recruited

3,400+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40774623/

Outcomes of glepaglutide on intestinal absorption and ...

Outcomes of glepaglutide on intestinal absorption and parenteral support in patients with short bowel syndrome · Authors · Affiliations.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07228403?aggFilters=status%3A%2Cphase%3A

Efficacy and Safety Evaluation of Glepaglutide in Treatment ...

The purpose of this study is to understand the safety and efficacy of twice weekly glepaglutide 10 mg in adult patients with short bowel ...

3.

gastrojournal.org

gastrojournal.org/article/S0016-5085(24)05787-1/fulltext

Glepaglutide, a Long-Acting Glucagon-like Peptide-2 ...

Glepaglutide, a long-acting glucagon-like peptide-2 analogue, reduces parenteral support in patients with short bowel syndrome.

4.

clinicalnutritionespen.com

clinicalnutritionespen.com/article/S2405-4577(23)01266-4/fulltext

Results of ease sbs 1 phase 3 trial

Glepaglutide treatment of SBS-IF resulted in significant reductions in PS and the ability to achieve enteral autonomy in both patients without or with CiC.

5.

sciencedirect.com

sciencedirect.com/science/article/pii/S0016508524057871

Glepaglutide, a Long-Acting Glucagon-like Peptide-2 ...

Glepaglutide treatment in patients with SBS with intestinal failure resulted in clinically relevant reductions in PS requirements and was well tolerated. ( ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/39708985/

Glepaglutide, a Long-Acting Glucagon-like Peptide-2 ...

Glepaglutide is a long-acting glucagon-like peptide (GLP)-2 analogue developed to improve intestinal absorption in patients with short bowel syndrome (SBS).

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03690206

Study Details | NCT03690206 | Efficacy And Safety ...

The primary objective of the trial is to confirm the efficacy of glepaglutide in reducing parenteral support volume in patients with short bowel syndrome.

8.

journals.lww.com

journals.lww.com/transplantjournal/fulltext/2023/07001/66__glepaglutide_induces_meaningful_clinical.62.aspx

66: Glepaglutide Induces Meaningful Clinical Improvement ...

Glepaglutide was assessed to be safe and well-tolerated. More adverse events were reported in the glepaglutide treatment groups than for placebo, primarily ...

9.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S240545772502892X

Outcomes of Glepaglutide on Intestinal Absorption and ...

Patients with SBS treated with glepaglutide demonstrated increased intestinal wet weight and energy absorption, allowing corresponding ...