STARS Phase III: Once-Weekly Apraglutide Reduces Parenteral-Support Dependence in Short-Bowel Syndrome: CGH | September 2026 | Phase III STARS Trial

Introduction:

Patients with short-bowel syndrome with intestinal failure (SBS-IF) may require long-term parenteral support, creating substantial treatment burden and catheter-related risks. STARS evaluated apraglutide, a once-weekly GLP-2 analogue, for reducing parenteral-support requirements.

Why was this study needed?

Long-term parenteral support carries significant burden and complications.

GLP-2 therapy can enhance intestinal absorption and adaptation.

A once-weekly treatment could simplify long-term therapy.

Robust Phase III evidence was required to establish efficacy and safety.

Key Findings:

163 patients with SBS-IF were randomized to apraglutide or placebo.

At week 24, parenteral-support volume decreased 25.5% with apraglutide vs 12.5% with placebo.

43.0% vs 27.5% achieved at least one additional parenteral-support–free day per week.

Apraglutide was generally well tolerated.

Complete enteral autonomy occurred only in a minority.

In the colon-in-continuity subgroup, enteral autonomy was not significantly improved at week 48.

Apraglutide remains investigational and is not yet approved for routine prescribing.

Bottom Line:

Once-weekly apraglutide meaningfully reduced parenteral-support requirements in SBS-IF. STARS provides strong Phase III evidence for a potentially less burdensome GLP-2 therapy, pending regulatory approval.