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Background <p>Elobixibat is a locally acting ileal bile acid transporter (IBAT) inhibitor that relieves functional constipation in patients by accelerating colonic transit. In this study, we aimed at determining the efficacy and safety of elobixibat for short-term treatment (two&#xa0;weeks) of chronic constipation in Indian patients.</p> Methods <p>The present study was a randomized, double-blind, parallel-group, placebo-controlled, phase III study to evaluate efficacy and safety of elobixibat. The study planned to enroll patients with chronic constipation of at least six&#xa0;months'&#xa0;duration, satisfying Rome IV criteria for functional constipation. Following a run-in of approximately 14&#xa0;days to confirm eligibility and determine baseline frequency of spontaneous bowel movements (SBMs), eligible patients were randomized 1:1 either to elobixibat or to placebo groups. The change in weekly frequency of spontaneous bowel movements (SBMs) at the end of treatment (week two) over baseline was the primary efficacy endpoint in this trial. Primary efficacy analyses were based on the modified intention-to-treat (mITT) population. This trial is registered at CTRI (Clinical Trial Registry of India).</p> Results <p>Between April 2023 and December 2023, 150 patients were randomized into the two-week trial. In mITT population (<i>n</i> = 146 [elobixibat = 75 and placebo = 71]), the least square mean (LSM) difference between elobixibat (3.83) and placebo (2.68) was 1.15 (95% CI, 0.31, 1.99) demonstrating a statistically significant improvement (<i>p</i> = 0.008) in weekly frequency of SBMs (week two over baseline) with the use of elobixibat. The proportions of patients with a&#xa0;complete spontaneous bowel movement&#xa0;(CSBM)&#xa0;“response” was significantly higher with elobixibat (49.33%) compared to the placebo (26.76%) treatment (difference 22.57% [95% CI, 8.36%, 36.78%] [<i>p</i> = 0.005]). The most common adverse event (AE) was abdominal pain (elobixibat = 6 patients [7.89%] vs. placebo = 3 patients [4.05%]).</p> Conclusions <p>Elobixibat was well tolerated and improved bowel movement frequency within two&#xa0;weeks of treatment in Indian patient population with chronic constipation.</p> Clinical trial registry number <p>CTRI/2022/10/046690</p> Graphical Abstract <p></p>

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Efficacy and safety of elobixibat in patients with chronic constipation—A randomized, multicenter, double-blind, placebo-controlled, parallel-group study from India

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年2月22日

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  • Piyush Agarwal,
  • Brajesh Kumar Jha,
  • Jaganmohan Somagoni,
  • Srinivas Shenoy B,
  • Vipul Modh,
  • Sanketh Kumar Chakilam,
  • Vinay Kumar,
  • Mukewar Shrikant Vasantrao,
  • Mukesh Kalla,
  • Anumula Kavitha,
  • Omesh Goyal,
  • Ashima Bhatia

摘要

Background

Elobixibat is a locally acting ileal bile acid transporter (IBAT) inhibitor that relieves functional constipation in patients by accelerating colonic transit. In this study, we aimed at determining the efficacy and safety of elobixibat for short-term treatment (two weeks) of chronic constipation in Indian patients.

Methods

The present study was a randomized, double-blind, parallel-group, placebo-controlled, phase III study to evaluate efficacy and safety of elobixibat. The study planned to enroll patients with chronic constipation of at least six months' duration, satisfying Rome IV criteria for functional constipation. Following a run-in of approximately 14 days to confirm eligibility and determine baseline frequency of spontaneous bowel movements (SBMs), eligible patients were randomized 1:1 either to elobixibat or to placebo groups. The change in weekly frequency of spontaneous bowel movements (SBMs) at the end of treatment (week two) over baseline was the primary efficacy endpoint in this trial. Primary efficacy analyses were based on the modified intention-to-treat (mITT) population. This trial is registered at CTRI (Clinical Trial Registry of India).

Results

Between April 2023 and December 2023, 150 patients were randomized into the two-week trial. In mITT population (n = 146 [elobixibat = 75 and placebo = 71]), the least square mean (LSM) difference between elobixibat (3.83) and placebo (2.68) was 1.15 (95% CI, 0.31, 1.99) demonstrating a statistically significant improvement (p = 0.008) in weekly frequency of SBMs (week two over baseline) with the use of elobixibat. The proportions of patients with a complete spontaneous bowel movement (CSBM) “response” was significantly higher with elobixibat (49.33%) compared to the placebo (26.76%) treatment (difference 22.57% [95% CI, 8.36%, 36.78%] [p = 0.005]). The most common adverse event (AE) was abdominal pain (elobixibat = 6 patients [7.89%] vs. placebo = 3 patients [4.05%]).

Conclusions

Elobixibat was well tolerated and improved bowel movement frequency within two weeks of treatment in Indian patient population with chronic constipation.

Clinical trial registry number

CTRI/2022/10/046690

Graphical Abstract