Glepaglutide for Short Bowel Syndrome

(EASE SBS 2 Trial)

Not currently recruiting at 31 trial locations

Overseen By Senior Clinical Trial Manager

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Zealand Pharma

Must not be taking: GLP-1, GLP-2, others

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: 2 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety of glepaglutide, a new treatment option for individuals with short bowel syndrome (SBS). SBS occurs when the body cannot absorb enough nutrients due to a missing or malfunctioning part of the small intestine. The trial includes two groups: one receives glepaglutide injections twice a week, while the other receives a combination of glepaglutide and placebo once a week. Ideal candidates for this trial have already completed a specific earlier trial related to this treatment. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants to contribute to the potential availability of a new treatment.

Will I have to stop taking my current medications?

The trial requires that you stop using GLP-1, GLP-2, human growth hormone, somatostatin, or similar medications at least 3 months before joining. For other medications, the protocol does not specify, so it's best to discuss with the trial team.

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

Research has shown that glepaglutide is generally safe for people with short bowel syndrome (SBS). One study found that a single dose of glepaglutide was well-tolerated, even by those with severe kidney problems, with most participants not experiencing significant side effects.

Another study examined glepaglutide's effects on SBS and confirmed its safety, as participants reported few serious issues. This is encouraging for those considering joining a trial for glepaglutide. While every treatment can have some side effects, the research so far suggests that glepaglutide is safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Glepaglutide is unique because it uses a Glucagon-Like Peptide-2 (GLP-2) analog, which is not a common approach in current treatments for Short Bowel Syndrome. Unlike other treatments, Glepaglutide is administered through subcutaneous injections either once or twice weekly, potentially offering more flexibility and convenience. Researchers are excited about Glepaglutide because its mechanism targets improved nutrient absorption and intestinal growth, which could lead to better management of symptoms and quality of life for patients with Short Bowel Syndrome.

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

Research has shown that glepaglutide may help people with short bowel syndrome (SBS). Studies have found that it can greatly reduce the need for intravenous nutritional support, which is crucial for those with SBS. Glepaglutide mimics a natural hormone called GLP-2, enhancing nutrient absorption in the intestines. Patients using glepaglutide have experienced significant improvements, such as better nutrient absorption and reduced reliance on intravenous feeding. These findings suggest that glepaglutide could effectively manage SBS. Participants in this trial will receive either glepaglutide subcutaneous injections twice weekly or glepaglutide once weekly with a placebo once weekly, as part of the study's different treatment arms. ^{1 2 3 4 6}

Who Is on the Research Team?

Zealand Pharma

Principal Investigator

Zealand Pharma

Are You a Good Fit for This Trial?

This trial is for patients with Short Bowel Syndrome who completed previous related trials (ZP1848-17111 or ZP1848-15073) and gave informed consent. It's not for those at undue risk, pregnant or breastfeeding women, or anyone using certain growth hormones within the last 3 months.

Inclusion Criteria

Completed the lead-in trial (ZP1848-17111) or completed the Phase 2 trial (ZP1848-15073)

Informed consent obtained before any trial-related activity

Exclusion Criteria

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

I haven't used GLP-1, GLP-2, growth hormone, or similar drugs in the last 3 months.

Withdrawal of consent from the lead-in trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Glepaglutide SC injections to assess long-term safety and efficacy

2 years

Twice weekly 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 trial tests the long-term safety and effectiveness of a drug called glepaglutide in treating Short Bowel Syndrome. Glepaglutide is also known as ZP1848.

How Is the Trial Designed?

Group I: Glepaglutide SC injections twice weekly Experimental Treatment 1 Intervention

Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection twice weekly. In this long term safety study, there is no placebo arm.

Group II: Glepaglutide SC injections once weekly and placebo once weekly Experimental Treatment 1 Intervention

Glucagon-Like Peptide-2 (GLP-2) analog, 10 mg subcutaneous injection once weekly and placebo once weekly. In this long term safety study, there is no placebo arm.

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 ... This study assessed glepaglutide in terms of its 24-week efficacy on intestinal wet weight and energy absorption, as well as its impact on ...

2. 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.

3. sciencedirect.com sciencedirect.com/science/article/pii/S2405457724014992

Real-world experience with glucagon-like peptide 2 ... Glepaglutide induces meaningful clinical improvement in patients with short bowel syndrome chronic intestinal failure: results of a phase 3 trial.

4. 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.

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

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 ...

6. 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 ...