PMID- 34287970
OWN - NLM
STAT- MEDLINE
DCOM- 20220527
LR  - 20220721
IS  - 1941-2444 (Electronic)
IS  - 0148-6071 (Print)
IS  - 0148-6071 (Linking)
VI  - 46
IP  - 4
DP  - 2022 May
TI  - Apraglutide, a novel glucagon-like peptide-2 analog, improves fluid absorption in 
      patients with short bowel syndrome intestinal failure: Findings from a 
      placebo-controlled, randomized phase 2 trial.
PG  - 896-904
LID - 10.1002/jpen.2223 [doi]
AB  - BACKGROUND: Treatment with glucagon-like peptide-2 (GLP-2) analogs improve 
      intestinal adaptation in patients with short bowel syndrome-associated intestinal 
      failure (SBS-IF) and may reduce parenteral support requirements. Apraglutide is a 
      novel, long-acting GLP-2 analog designed for once-weekly dosing. This trial 
      investigated the safety and efficacy of apraglutide in patients with SBS-IF. 
      METHODS: In this placebo-controlled, double-blind, randomized, crossover phase 2 
      trial, eight adults with SBS-IF were treated with once-weekly 5-mg apraglutide 
      doses and placebo for 4 weeks, followed by once-weekly 10-mg apraglutide doses 
      for 4 weeks, with a washout period of 6-10 weeks between treatments. Safety was 
      the primary end point. Secondary end points included changes from baseline in 
      urine volume output compared with placebo, collected for 48 h before and after 
      each treatment period. RESULTS: Common treatment-related adverse events (AEs) 
      were mild to moderate and included polyuria, decreased stoma output, stoma 
      complications, decreased thirst, and edema. No serious AEs were considered to be 
      related to apraglutide treatment. The safety profile was comparable for the lower 
      and higher doses. Treatment with once-weekly 5- and 10-mg apraglutide doses 
      significantly increased urine volume output by an adjusted mean of 714 ml/day 
      (95% CI, 490-939; P < .05) and 795 ml/day (95% CI, 195-1394; P < .05), 
      respectively, compared with placebo, with no significant differences between 
      doses. CONCLUSIONS: Once-weekly apraglutide was well tolerated at both tested 
      doses and significantly increased urine volume output, providing evidence for 
      increased intestinal fluid absorption. A phase 3 trial is underway in adults with 
      SBS-IF.
CI  - (c) 2021 The Authors. Journal of Parenteral and Enteral Nutrition published by 
      Wiley Periodicals LLC on behalf of American Society for Parenteral and Enteral 
      Nutrition.
FAU - Eliasson, Johanna
AU  - Eliasson J
AD  - Department of Intestinal Failure and Liver Diseases, Rigshospitalet, Copenhagen 
      University Hospital, Copenhagen, Denmark.
FAU - Hvistendahl, Mark K
AU  - Hvistendahl MK
AD  - Department of Intestinal Failure and Liver Diseases, Rigshospitalet, Copenhagen 
      University Hospital, Copenhagen, Denmark.
FAU - Freund, Nanna
AU  - Freund N
AD  - Department of Intestinal Failure and Liver Diseases, Rigshospitalet, Copenhagen 
      University Hospital, Copenhagen, Denmark.
FAU - Bolognani, Federico
AU  - Bolognani F
AD  - VectivBio AG, Basel, Switzerland.
FAU - Meyer, Christian
AU  - Meyer C
AD  - VectivBio AG, Basel, Switzerland.
FAU - Jeppesen, Palle B
AU  - Jeppesen PB
AD  - Department of Intestinal Failure and Liver Diseases, Rigshospitalet, Copenhagen 
      University Hospital, Copenhagen, Denmark.
LA  - eng
SI  - ClinicalTrials.gov/NCT03415594
PT  - Clinical Trial, Phase II
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20210907
PL  - United States
TA  - JPEN J Parenter Enteral Nutr
JT  - JPEN. Journal of parenteral and enteral nutrition
JID - 7804134
RN  - 0 (Glucagon-Like Peptide 2)
RN  - 0 (Peptides)
RN  - CVQ1IAY2G6 (apraglutide)
SB  - IM
MH  - Adult
MH  - Glucagon-Like Peptide 2/therapeutic use
MH  - Humans
MH  - Intestinal Absorption
MH  - *Intestinal Failure
MH  - Peptides/adverse effects
MH  - *Short Bowel Syndrome/drug therapy
PMC - PMC9292678
OTO - NOTNLM
OT  - glucagon-like peptide-2
OT  - intestinal adaptation
OT  - intestinal failure
OT  - parenteral support
OT  - short bowel syndrome
COIS- Palle B. Jeppesen has served as a consultant and speaker for VectivBio AG and was 
      the principal investigator in this study. Johanna Eliasson has served as a 
      consultant for VectivBio AG and was a study investigator. Mark K. Hvistendahl and 
      Nanna Freund were study investigators. Federico Bolognani and Christian Meyer are 
      employees of VectivBio AG.
EDAT- 2021/07/22 06:00
MHDA- 2022/05/28 06:00
PMCR- 2022/07/18
CRDT- 2021/07/21 13:15
PHST- 2021/07/22 06:00 [pubmed]
PHST- 2022/05/28 06:00 [medline]
PHST- 2021/07/21 13:15 [entrez]
PHST- 2022/07/18 00:00 [pmc-release]
AID - JPEN2223 [pii]
AID - 10.1002/jpen.2223 [doi]
PST - ppublish
SO  - JPEN J Parenter Enteral Nutr. 2022 May;46(4):896-904. doi: 10.1002/jpen.2223. 
      Epub 2021 Sep 7.