Evidence map›Paper›PMID 32930860›Full record

Trial reportWiener klinische Wochenschrift2021

Open-label phase II study evaluating safety and efficacy of the non-steroidal farnesoid X receptor agonist PX-104 in non-alcoholic fatty liver disease.

Stefan Traussnigg, Emina Halilbasic, Harald Hofer, Petra Munda, Tatjana Stojakovic, Günter Fauler, Karl Kashofer, Martin Krssak, Michael Wolzt, Michael Trauner

Open access · hybridAbstract readClinical Trial, Phase II
In one paragraph

Trial report in Wiener klinische Wochenschrift, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 21 papers.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed
3.9field-weighted citation impact, top 5% of its field
1 · What the graph read from 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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 41 citations in OpenAlex.

  1. Trial
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  7. Advances in fecal microbiota transplantation for the treatment of diabetes mellitus.Frontiers in cellular and infection microbiology · 2024
    Review
  8. Review
  9. Article
  10. Role of FXR in Renal Physiology and Kidney Diseases.International journal of molecular sciences · 2023
    Review
  11. Article
  12. Review
  13. Lipid alterations in chronic liver disease and liver cancer.JHEP reports : innovation in hepatology · 2022
    Review
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  15. Review
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors at 2 institutions in 1 country.

Stefan TraussniggDivision of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Emina HalilbasicDivision of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Harald HoferDivision of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Petra MundaDivision of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria.
Tatjana StojakovicClinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Graz, Austria.
Günter FaulerClinical Institute of Medical and Chemical Laboratory Diagnostics, Medical University of Graz, Graz, Austria.
Karl KashoferInstitute of Pathology, Medical University of Graz, Graz, Austria.
Martin KrssakHigh-Field MR Center, Department of Biomedical Imaging and Image-guided Therapy, Medical University of Vienna, Vienna, Austria.
Michael WolztDepartment of Clinical Pharmacology, Medical University of Vienna, Vienna, Austria.
Michael TraunerDivision of Gastroenterology and Hepatology, Department of Internal Medicine III, Medical University of Vienna, Waehringer Guertel 18-20, 1090, Vienna, Austria. michael.trauner@meduniwien.ac.at.
Medical University of Vienna · ATMedical University of Graz · AT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe PX-104 is an oral non-steroidal agonist for the farnesoid X receptor (FXR), a key regulator of bile acid (BA), glucose and lipid homeostasis. AIMS AND

methodsThis single center, proof of concept study evaluated the efficacy, safety and tolerability of PX-104 in non-diabetic NAFLD patients. 12 individuals were treated daily with 5 mg of PX-104 orally for 4 weeks. Serum liver enzymes, insulin sensitivity by clamp like index (CLIX) and hepatic fat by proton

resultsA significant decrease in ALT (p = 0.027; 1‑tailed) and GGT (p = 0.019) was observed, without changes in serum alkaline phosphatase or serum lipids. Insulin sensitivity improved in 92% of patients (p = 0.02). However, hepatic steatosis measured by PDFF-MRI,

conclusionThe non-steroidal FXR agonist PX-104 improved insulin sensitivity and liver enzymes after 4 weeks of treatment in non-diabetic NAFLD patients. Changes in fecal BAs and gut microbiota deserve more extensive investigations.

Indexed as

Non-alcoholic Fatty Liver DiseaseBile Acids and SaltsHumansLiverReceptors, Cytoplasmic and NuclearSignal TransductionBile Acids and SaltsReceptors, Cytoplasmic and NuclearFatty liverFXRInsulin resistanceNAFLDTherapy

Identifiers

PMID32930860
PMCPMC8116226
OpenAlexW3087550178

What OpenQuestion holds

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Registered trials

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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.