What is the mechanism of action of this treatment?

The most common treatments for Short Bowel Syndrome (SBS) include GLP-2 analogs like glepaglutide, which enhance intestinal absorption by promoting mucosal growth and increasing the absorptive capacity of the remaining intestine. This is particularly important for SBS patients, as they have a reduced intestinal surface area, leading to malabsorption and nutrient deficiencies. By improving nutrient uptake, GLP-2 analogs help reduce the need for parenteral nutrition and improve the overall quality of life for these patients. Other treatments may include dietary modifications, oral rehydration solutions, and medications to slow intestinal transit time, but GLP-2 analogs are specifically designed to address the core issue of impaired absorption in SBS.

What side effects are associated with this type of intervention?

Common treatments for Short Bowel Syndrome (SBS) include GLP-2 analogs like glepaglutide, which enhance intestinal absorption. Known side effects of GLP-2 analogs can include gastrointestinal symptoms such as abdominal pain, nausea, and diarrhea. Other treatments for SBS may involve parenteral nutrition, which carries risks of infections, liver disease, and metabolic complications. Additionally, medications to slow intestinal transit or reduce gastric acid secretion can cause side effects like bloating, constipation, and electrolyte imbalances.

What prior FDA approvals exist?

Teduglutide, a GLP-2 analog, is an FDA-approved treatment for Short Bowel Syndrome. It enhances intestinal absorption by promoting the growth and function of the remaining intestinal mucosa. This mechanism is similar to that of glepaglutide, which is currently being studied for its long-term safety and efficacy in treating SBS. Teduglutide has been shown to reduce the need for parenteral nutrition in patients with SBS, making it a significant advancement in the management of this condition.

What other types of research exist?

Promising novel alternatives to Glepaglutide for Short Bowel Syndrome patients include other GLP-2 analogs such as Teduglutide, which is already approved and enhances intestinal absorption. Additionally, any new GLP-2 analogs or therapies targeting similar pathways that are currently in clinical trials or have recently been approved could be considered as potential alternatives.

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Glucagon-like peptide-2 (GLP-2) analog

Glepaglutide for Short Bowel Syndrome (EASE SBS 3 Trial)

Phase 3

Waitlist Available

Research Sponsored by Zealand Pharma

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Females of childbearing potential, who are pregnant, breast-feeding, intend to become pregnant, or are not using highly effective contraceptive methods

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 in lead-in trial (ease sbs 1), week 108

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial is testing if glepaglutide is safe and effective for people with Short Bowel Syndrome (SBS) over a long period. Participants will receive regular injections under the skin to see if it helps their intestines absorb nutrients better. Glepaglutide is a new treatment being tested for its effectiveness in patients with short bowel syndrome.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, common side effects from similar treatments include digestive issues, injection site reactions, fatigue, and possible allergic responses.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 in lead-in trial (ease sbs 1), week 108

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 in lead-in trial (ease sbs 1), week 108

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 in lead-in trial (ease sbs 1), week 108 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence and type of Adverse Events (AEs)

Secondary study objectives

Change in blood pressure

Incidence and type of Adverse Events of Special Interest (AESIs)

Incidence and type of Serious Adverse Events (SAEs)

Side effects data

From 2023 Phase 3 trial • 12 Patients • NCT04991311

80%

Gastrointestinal stoma complication

70%

Injection site pain

50%

Oedema peripheral

50%

Injection site reaction

30%

Abdominal pain

30%

Weight decreased

30%

Injection site pruritus

30%

Diarrhoea

30%

Dehydration

30%

Dizziness

20%

Device related sepsis

20%

Urinary tract infection

20%

Gastrointestinal stoma output abnormal

20%

Urine output decreased

20%

Fatigue

20%

Injection site erythema

20%

Abdominal distension

20%

Back pain

20%

Muscle spasms

20%

Pain in extremity

20%

COVID-19

20%

Decreased appetite

20%

Stoma site dermatitis

20%

Weight increased

20%

Hot flush

10%

Metastatic neoplasm

10%

Stoma obstruction

10%

Altered state of consciousness

10%

Crohn's disease

10%

Nausea

10%

Pelvic fluid collection

10%

Pulmonary mass

10%

Stoma site abscess

10%

Blood alkaline phosphatase increased

10%

Blood creatinine increased

10%

Gastrointestinal stoma output increased

10%

Fall

10%

Hypotension

10%

Vasculitis

10%

Post viral fatigue syndrome

10%

Malaise

10%

Hypoacusis

10%

Vertigo

10%

Abdominal hernia

10%

Abdominal pain upper

10%

Stomal hernia

10%

Alanine aminotransferase increased

10%

Asthma

10%

Cough

10%

Rhinorrhoea

10%

Arthralgia

10%

Musculoskeletal pain

10%

Osteoarthritis

10%

Torticollis

10%

Conjunctivitis

10%

Erysipelas

10%

Folliculitis

10%

Nasopharyngitis

10%

Oral candidiasis

10%

Pneumonia

10%

Sinusitis

10%

Hypertriglyceridaemia

10%

Hypophosphataemia

10%

Pruritus

10%

Supraventricular extrasystoles

10%

Insomnia

10%

Nephrolithiasis

10%

Ovarian cyst

10%

Musculoskeletal discomfort

10%

Influenza like illness

10%

Thirst

10%

Dyspepsia

10%

Catheter site infection

10%

Oesophageal candidiasis

10%

Tooth abscess

100%

80%

60%

40%

20%

Study treatment Arm

Once-weekly Glepaglutide

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: once-weekly glepaglutideExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glepaglutide

2017

Completed Phase 3

~190

0 / 1Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Short Bowel Syndrome (SBS) include GLP-2 analogs like glepaglutide, which enhance intestinal absorption by promoting mucosal growth and increasing the absorptive capacity of the remaining intestine. This is particularly important for SBS patients, as they have a reduced intestinal surface area, leading to malabsorption and nutrient deficiencies. By improving nutrient uptake, GLP-2 analogs help reduce the need for parenteral nutrition and improve the overall quality of life for these patients. Other treatments may include dietary modifications, oral rehydration solutions, and medications to slow intestinal transit time, but GLP-2 analogs are specifically designed to address the core issue of impaired absorption in SBS.