Glepaglutide for Short Bowel Syndrome

(EASE SBS 2 Trial)

Recruiting at 28 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

145 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug Glepaglutide for Short Bowel Syndrome?

Research shows that Glepaglutide, a long-acting version of a natural body substance called GLP-2, helps people with Short Bowel Syndrome by reducing stool output and improving nutrient absorption. It also appears to improve gut and liver function, which are often affected in this condition. ^{1 2 3 4 5}

Is Glepaglutide safe for humans?

Glepaglutide has been studied for safety in people with short bowel syndrome and those with different levels of kidney function. These studies suggest it is generally safe, but as with any medication, there may be side effects, and it's important to discuss these with your doctor. ^{1 2 3 4 5}

How is the drug Glepaglutide unique for treating short bowel syndrome?

Glepaglutide is unique because it is a long-acting glucagon-like peptide-2 (GLP-2) analogue, which helps improve intestinal absorption and reduce fecal output in patients with short bowel syndrome. It is administered as a subcutaneous injection, and its long-acting nature means it may require less frequent dosing compared to other treatments. ^{1 2 3 4 5}

What is the purpose of this trial?

The primary objective of the trial is to evaluate the long-term safety of glepaglutide treatment in patients with short bowel syndrome (SBS). Glepaglutide is the International Nonproprietary Name and USAN for ZP1848.

Research Team

Zealand Pharma

Principal Investigator

Zealand Pharma

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, for patients with short bowel syndrome: a randomised phase 2 trial. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Glepaglutide, A Long-Acting Glucagon-Like Peptide-2 Analogue: A Study in Healthy Subjects. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Safety, and Tolerability of Glepaglutide, a Long-Acting GLP-2 Analog, in Subjects with Renal Impairment. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Effect of Glepaglutide, a Long-Acting Glucagon-Like Peptide-2 Analog, on Gastrointestinal Transit Time and Motility in Patients With Short Bowel Syndrome: Findings From a Randomized Trial. [2021]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Effects of glepaglutide, a novel long-acting glucagon-like peptide-2 analogue, on markers of liver status in patients with short bowel syndrome: findings from a randomised phase 2 trial. [2020]