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Study · Randomized controlled trial · n = 163 · 2026

6 results

STARS Phase 3 Trial: Once-Weekly Apraglutide Reduces Parenteral Support in Short Bowel Syndrome-Intestinal Failure.

Joly F, Vanuytsel T, Kirby DF, Lal S, Tappenden K, Jeppesen PB, Venick R, Kunecki M, Szczepanek K, Matras P, Li C, Masior T, Valencia P, Boules M, Iyer KR

Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association3 Sept 2026

PMID42692160 (opens in a new tab)DOI10.1016/j.cgh.2026.08.026 (opens in a new tab)PepBankPUB-42692160
Publisher pagePubMedAsk about this study
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Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: Publisher copyright. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In patients with SBS-IF, mean relative change in weekly parenteral support volume at week 24 was -25.5% with apraglutide versus -12.5% with placebo.

    In plain wordsIn people with short bowel syndrome, apraglutide reduced intravenous support volume more than placebo at week 24.

    Peptide
    Apraglutide
    Outcome
    DecreaseWeekly parenteral support volume, overall
    Study

    n = 163

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Intensive care and hospital outcomes · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Mean relative change in weekly parenteral support volume
    −25.5%
    apraglutide, overall population, week 24
    Mean relative change in weekly parenteral support volume
    −12.5%
    placebo, overall population, week 24

    Source sentences

    Summary
    Apraglutide significantly reduced weekly PS volume from baseline vs placebo at week 24 in the overall population (mean relative change, -25.5% vs -12.5%; P = .001) and stoma subgroup (-25.6% vs -7.8%; P < .001).
    1 context sentence
    Summary · context
    In this global, phase 3, double-blind, placebo-controlled trial, eligible patients were randomized 2:1 to once-weekly subcutaneous apraglutide or placebo, stratified by remnant intestinal anatomy (stoma or colon-in-continuity [CIC]).
  2. 02HumanRandomized controlled trialEfficacy outcome

    In SBS-IF, 43.0% receiving apraglutide versus 27.5% receiving placebo achieved at least one fewer support day weekly at week 24.

    In plain wordsIn people with short bowel syndrome, more apraglutide recipients than placebo recipients achieved fewer weekly intravenous support days.

    Peptide
    Apraglutide
    Outcome
    IncreaseAt least one fewer support day weekly
    Study

    n = 163

    Comparator
    placebo
    Analysis
    Secondary
    Outcome group
    Intensive care and hospital outcomes · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Patients with reduction of at least 1 day/week of parenteral support
    43%
    apraglutide, week 24
    Patients with reduction of at least 1 day/week of parenteral support
    27.5%
    placebo, week 24

    Source sentences

    Summary
    A higher proportion of patients receiving apraglutide vs placebo achieved a reduction of ≥1 day/week of PS at week 24 (43.0% vs 27.5%; P = .040).
    1 context sentence
    Summary · context
    In this global, phase 3, double-blind, placebo-controlled trial, eligible patients were randomized 2:1 to once-weekly subcutaneous apraglutide or placebo, stratified by remnant intestinal anatomy (stoma or colon-in-continuity [CIC]).
  3. 03HumanRandomized controlled trialEfficacy outcome

    In SBS-IF with CIC, support-day response was 51.8% with apraglutide versus 44.4% with placebo, without a significant difference.

    In plain wordsIn people with short bowel syndrome and colon continuity, weekly support-day response did not differ significantly between apraglutide and placebo.

    Peptide
    Apraglutide
    Outcome
    No significant changeAt least one fewer support day weekly, CIC
    Study

    n = 83

    Comparator
    placebo
    Analysis
    Secondary
    Outcome group
    Intensive care and hospital outcomes · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous · 48 weeksAs given in this study (human).

    Measurements

    Patients with reduction of at least 1 day/week of parenteral support
    51.8%
    apraglutide, CIC, week 48
    Patients with reduction of at least 1 day/week of parenteral support
    44.4%
    placebo, CIC, week 48

    Source sentences

    Summary
    At week 48 (CIC), in the apraglutide vs placebo arms, the proportions of patients achieving a reduction of ≥1 day/week of PS and enteral autonomy were 51.8% vs 44.4% (P = .348) and 12.5% vs 7.4% (nominal P = .387), respectively.
    1 context sentence
    Summary · context
    In this global, phase 3, double-blind, placebo-controlled trial, eligible patients were randomized 2:1 to once-weekly subcutaneous apraglutide or placebo, stratified by remnant intestinal anatomy (stoma or colon-in-continuity [CIC]).
  4. 04HumanRandomized controlled trialEfficacy outcome

    In SBS-IF with CIC, enteral autonomy was 12.5% with apraglutide versus 7.4% with placebo, without a significant difference.

    In plain wordsIn people with short bowel syndrome and colon continuity, independence from intravenous support did not differ significantly between apraglutide and placebo.

    Peptide
    Apraglutide
    Outcome
    No significant changeEnteral autonomy, CIC
    Study

    n = 83

    Comparator
    placebo
    Analysis
    Secondary
    Outcome group
    Intensive care and hospital outcomes · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous · 48 weeksAs given in this study (human).

    Measurements

    Enteral autonomy proportion
    12.5%
    apraglutide, CIC, week 48
    Enteral autonomy proportion
    7.4%
    placebo, CIC, week 48

    Source sentences

    Summary
    At week 48 (CIC), in the apraglutide vs placebo arms, the proportions of patients achieving a reduction of ≥1 day/week of PS and enteral autonomy were 51.8% vs 44.4% (P = .348) and 12.5% vs 7.4% (nominal P = .387), respectively.
    1 context sentence
    Summary · context
    In this global, phase 3, double-blind, placebo-controlled trial, eligible patients were randomized 2:1 to once-weekly subcutaneous apraglutide or placebo, stratified by remnant intestinal anatomy (stoma or colon-in-continuity [CIC]).
  5. 05HumanRandomized controlled trialEfficacy outcome

    In the SBS-IF stoma subgroup, mean relative change in weekly parenteral support volume at week 24 was -25.6% with apraglutide versus -7.8% with placebo.

    In plain wordsIn people with short bowel syndrome and a stoma, apraglutide reduced intravenous support volume more than placebo.

    Peptide
    Apraglutide
    Outcome
    DecreaseWeekly parenteral support volume, stoma subgroup
    Study

    n = 80

    Comparator
    placebo
    Analysis
    Secondary
    Outcome group
    Intensive care and hospital outcomes · Gastrointestinal
    Studied dose
    Dose not stated · subcutaneous · 24 weeksAs given in this study (human).

    Measurements

    Mean relative change in weekly parenteral support volume
    −25.6%
    apraglutide, stoma subgroup, week 24
    Mean relative change in weekly parenteral support volume
    −7.8%
    placebo, stoma subgroup, week 24

    Source sentences

    Summary
    Apraglutide significantly reduced weekly PS volume from baseline vs placebo at week 24 in the overall population (mean relative change, -25.5% vs -12.5%; P = .001) and stoma subgroup (-25.6% vs -7.8%; P < .001).
    1 context sentence
    Summary · context
    In this global, phase 3, double-blind, placebo-controlled trial, eligible patients were randomized 2:1 to once-weekly subcutaneous apraglutide or placebo, stratified by remnant intestinal anatomy (stoma or colon-in-continuity [CIC]).
  6. 06HumanRandomized controlled trialSafety outcome

    In SBS-IF, apraglutide was reported as well tolerated.

    In plain wordsIn people with short bowel syndrome, apraglutide was reported as well tolerated.

    Peptide
    Apraglutide
    Outcome
    Not applicableTolerability
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · subcutaneousAs given in this study (human).

    Source sentences

    Summary
    Apraglutide was well-tolerated with a favorable safety profile.
    1 context sentence
    Summary · context
    In this global, phase 3, double-blind, placebo-controlled trial, eligible patients were randomized 2:1 to once-weekly subcutaneous apraglutide or placebo, stratified by remnant intestinal anatomy (stoma or colon-in-continuity [CIC]).

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

  1. Version 2Current

    27 Oct 2026, 18:20 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:32 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

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