Glepaglutide for Short Bowel Syndrome

(EASE SBS 3 Trial)

Not currently recruiting at 21 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Zealand Pharma

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

Disqualifiers: Pregnancy, Breast-feeding, 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 whether glepaglutide is safe and effective for people with Short Bowel Syndrome (SBS). Participants will receive a weekly injection under the skin for about two years to assess the treatment's long-term effectiveness. The trial seeks individuals who have completed an earlier related study and are managing SBS. As a Phase 3 trial, it represents the final step before FDA approval, giving participants the opportunity to contribute to a potentially groundbreaking treatment.

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

You will need to stop taking medications like GLP-1, GLP-2, human growth hormone, DPP-4 inhibitors, and somatostatin at least 3 months before joining the trial. If you're on other medications, the trial protocol doesn't specify, so it's best to discuss with the trial team.

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

Research has shown that glepaglutide is generally safe for people with Short Bowel Syndrome (SBS). In earlier studies, patients who took glepaglutide found it safe and easy to tolerate, with most experiencing no serious side effects.

One study tested a single dose of glepaglutide in people with and without kidney issues and found that participants handled it well, with no major safety concerns. Another study demonstrated that treatments similar to glepaglutide, called GLP-2, were safe and helped improve certain body functions in people with SBS.

While this trial aims to confirm long-term safety, past research suggests that glepaglutide is safe to use. ^{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 once-weekly injection option for managing Short Bowel Syndrome (SBS), which could significantly simplify treatment regimens for patients. Unlike current treatments that often involve daily injections or intravenous feeding, glepaglutide is a long-acting GLP-2 analog designed to enhance intestinal absorption. Researchers are excited because it has the potential to improve quality of life by reducing the need for more frequent and invasive interventions.

What evidence suggests that glepaglutide might be an effective treatment for Short Bowel Syndrome?

Research shows that glepaglutide helps people with short bowel syndrome (SBS) by improving nutrient absorption in the intestines. Studies have found that glepaglutide can reduce the need for parenteral support, where patients receive nutrients directly through their veins, allowing them to eat more normally. Glepaglutide is a long-acting version of a natural hormone that maintains gut health, facilitating nutrient absorption from food. Previous findings have shown that this treatment helps patients become more independent in their daily lives. Overall, glepaglutide has shown promise in improving life for those with SBS. ^{1 3 6 7 8}

Who Is on the Research Team?

Zealand Pharma

Principal Investigator

Zealand Pharma

Are You a Good Fit for This Trial?

This trial is for individuals who have completed the EASE SBS 2 trial for Short Bowel Syndrome (SBS) and are not using certain other medications or treatments. Women must use effective contraception if of childbearing potential, and participants should not have any conditions that may interfere with the study.

Inclusion Criteria

Completed the full treatment period of the extension trial EASE SBS 2 (ZP1848-17127)

Informed consent obtained before any trial-related activity

Exclusion Criteria

I haven't had a colonoscopy at the end of the EASE SBS 2 trial, or it was safe.

I haven't used GLP-1, GLP-2, HGH, DPP-4 inhibitors, or somatostatin in the last 3 months.

I am not pregnant, breastfeeding, planning to become pregnant, or using effective birth control.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive 10 mg of glepaglutide as once-weekly injections under the skin for approximately 2 years

104 weeks

Once-weekly visits for injections

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 study tests the long-term safety and effectiveness of glepaglutide in treating SBS. Participants will receive weekly subcutaneous injections of glepaglutide over a period of approximately two years.

How Is the Trial Designed?

Group I: once-weekly glepaglutide Experimental Treatment 1 Intervention

All participants will receive 10 mg of glepaglutide as once-weekly injections under the skin (subcutaneous, s.c.)

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 ... ... short bowel syndrome (SBS). GLP-2 enhances intestinal adaptation and absorption. This study assessed glepaglutide in terms of its 24-week ...

2. 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.

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

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1091255X24004128

Efficacy and safety of glucagon-like peptide 2 in patients ... GLP-2 seems to be safe and effective in patients with SBS. GLP-2 showed a positive effect on increasing plasma citrulline level and decreasing ALP level.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10085944/

Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a ... A single SC dose of glepaglutide 10 mg appeared safe and well tolerated in subjects with normal renal function and subjects with severe renal impairment or ...