Peptide Graded

Apraglutide

Does Apraglutide work?

Partly: some human trials, with gaps. One trial of 163 adults.

BSome human evidenceIn clinical trialsas of 2026-10-27

The main evidence is STARS, a randomized, double-blind, placebo-controlled phase 3 trial in 163 adults with short bowel syndrome dependent on intravenous nutrition, which met its primary endpoint on a surrogate measure (volume of parenteral support); a 9-patient open-label phase 2 study adds absorption data. One phase 3 trial with a surrogate endpoint, a non-significant result in patients with colon in continuity, and no approval yet is grade B. 12

In the STARS trial, researchers randomized 163 adults with SBS-IF 2:1 to weekly apraglutide injected under the skin (110 patients) or placebo (53). They split patients by whether they had a stoma (80 patients) or colon in continuity (83). At week 24, weekly parenteral support volume had fallen 25.5% with apraglutide versus 12.5% with placebo. Patients on apraglutide were more likely to gain at least one day a week off intravenous support (43% versus 27.5%). Seven patients on apraglutide (6.4%) became fully independent of parenteral support, versus none on placebo. That difference was not statistically significant in the prespecified analysis. 1

The benefit was concentrated in patients with a stoma. Their reduction at week 24 was 25.6% versus 7.8%. Patients with colon in continuity were treated for 48 weeks. Their results all favored apraglutide but were not statistically significant. Volume fell 35.4% versus 23.2%, days off support rose 51.8% versus 44.4%, and enteral autonomy reached 12.5% versus 7.4%. This group also responded more to placebo, which partly explains the gap. 1

Evidence checklist

  • Randomised controlled trial STARS phase 3, placebo-controlled
  • Human study over 100 people STARS, 163 adults
  • More than one research group One phase 3 trial; no second group cited
  • Clinical outcomes, not surrogate markers Surrogate: volume of intravenous nutrition
  • Human safety data beyond case reports Dropout 3.6% vs 1.9% on placebo; polyp concern open

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More on Apraglutide

Citations

  1. Joly 2026, Clinical Gastroenterology and Hepatology: STARS phase 3 trial of once-weekly apraglutide in SBS-IF doi.org
  2. Verbiest 2024, Clinical Nutrition: open-label phase 2 metabolic balance study of apraglutide in SBS-IF with colon-in-continuity doi.org
  3. ClinicalTrials.gov: NCT07742735, second phase 3 trial of apraglutide clinicaltrials.gov

Reference information only, not medical advice. Drawn from the Apraglutide article, fact-checked against the cited sources. No dosing anywhere on this site.