Trial reportBMC cardiovascular disorders2015
Specific inhibition of bile acid transport alters plasma lipids and GLP-1.
Trial report in BMC cardiovascular disorders, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 22 papers, 2 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effects of A3309, an Ileal Bile Acid Transport Inhibitor, on Gastrointestinal and Colonic Motor Functions in Female Patients With Functional Constipation
A Phase IIa, Double-blind, Randomised, Placebo-controlled, Dose-finding Efficacy and Safety Study of A3309 in Patients With Dyslipidemia
Who cites it
22 citing papers in PubMed, 2 syntheses or guidelines pooled it, 57 citations in OpenAlex.
- Pooled it
- Bile Acids Transporters of Enterohepatic Circulation for Targeted Drug Delivery.Molecules (Basel, Switzerland) · 2022Pooled it
- Effects of Elobixibat in Patients with Diabetes and Concomitant Chronic Constipation: an 8-week, Prospective, Single-center, Single-arm Study.Advances in therapy · 2022Trial
- Postprandial glucose-lowering effect of premeal consumption of protein-enriched, dietary fiber-fortified bar in individuals with type 2 diabetes mellitus or normal glucose tolerance.Journal of diabetes investigation · 2018Trial
- Determining an optimal clinical dose of elobixibat, a novel inhibitor of the ileal bile acid transporter, in Japanese patients with chronic constipation: a phase II, multicenter, double-blind, placebo-controlled randomized clinical trial.Journal of gastroenterology · 2018Trial
- Safety, tolerability and pharmacodynamics of apical sodium-dependent bile acid transporter inhibition with volixibat in healthy adults and patients with type 2 diabetes mellitus: a randomised placebo-controlled trial.BMC gastroenterology · 2018Trial
- Benefits and challenges to therapeutic targeting of bile acid circulation in cholestatic liver disease.Hepatology (Baltimore, Md.) · 2025Review
- Bile acids and microbes in metabolic disease.World journal of gastroenterology · 2022Review
- Bile acids, bioactive signalling molecules in interoceptive gut-to-brain communication.The Journal of physiology · 2022Article
- Targeting the Enteroendocrine System for Treatment of Obesity.Handbook of experimental pharmacology · 2022Article
- Role of Bile Acids in the Regulation of Food Intake, and Their Dysregulation in Metabolic Disease.Nutrients · 2021Review
- Aberrant Gut-To-Brain Signaling in Irritable Bowel Syndrome - The Role of Bile Acids.Frontiers in endocrinology · 2021Review
- Enteroendocrine Hormone Secretion and Metabolic Control: Importance of the Region of the Gut Stimulation.Pharmaceutics · 2020Review
- Potential of ileal bile acid transporter inhibition as a therapeutic target in Alagille syndrome and progressive familial intrahepatic cholestasis.Liver international : official journal of the International Association for the Study of the Liver · 2020Review
- The effect of exenatide on fasting bile acids in newly diagnosed type 2 diabetes mellitus patients, a pilot study.BMC pharmacology & toxicology · 2020Article
- Bile acids in glucose metabolism and insulin signalling - mechanisms and research needs.Nature reviews. Endocrinology · 2019Review
- What's in the pipeline for lower functional gastrointestinal disorders in the next 5 years?American journal of physiology. Gastrointestinal and liver physiology · 2019Review
- Elobixibat for the treatment of constipation.Expert review of gastroenterology & hepatology · 2018Article
- Targeted intestinal delivery of incretin secretagogues-towards new diabetes and obesity therapies.Peptides · 2018Review
- Recent advances in understanding and managing chronic constipation.F1000Research · 2018Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors at 4 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundElobixibat is a minimally absorbed ileal bile acid (BA) transporter (IBAT) inhibitor in development against chronic constipation (CC) and constipation-predominant Irritable Bowel Syndrome (IBS-C). CC is associated with an increased risk for cardiovascular disease and type2 diabetes mellitus. The objectives of this study were to evaluate metabolic effects of elobixibat. Effects on plasma lipids and BA synthesis were evaluated utilizing a 4-week, placebo-controlled study in patients with dyslipidemia while changes of glucagon-like peptide-1 (GLP-1) by elobixibat was assayed in samples from a 14 day high-dose elobixibat study in patients with CC.
methodsThirty-six dyslipidemic patients, 21 females, mean age 63 years, were randomized to 2.5 mg or 5 mg elobixibat or placebo once daily for four weeks. The primary endpoint was the change in low density lipoprotein (LDL) cholesterol. Secondary endpoints included other lipid parameters and serum 7α-hydroxy-4-cholesten-3-one (C4), a marker of BA (bile acid) synthesis. Another study, in 36 patients with CC treated with high dose elobixibat; 15 mg or 20 mg/day or placebo for 14 days, was evaluated for changes in GLP-1.
resultsIn the dyslipidemia study LDL cholesterol was reduced by 7.4 % (p = 0.044), and the LDL/HDL ratio was decreased by 18 % (p = 0.004). Serum C4 increased, indicating that BA synthesis was induced. No serious adverse events were recorded. In the CC study, GLP-1 increased significantly in both the 15 mg (20.7 ± 2.4 pmol/L; p = 0.03) and the 20 mg group (25.6 ± 4.9 pmol/L; p = 0.02).
conclusionsElobixibat reduces LDL cholesterol and LDL/HDL ratio and increase circulating peak GLP-1 levels, the latter in line with increased intestinal BA mediated responses in humans. TRIAL REGISTRATIONS: ClinicalTrial.gov: NCT01069783 and NCT01038687 .
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.