Evidence map›Paper›PMID 36797481›Full record

Trial reportNature medicine2023

Tropifexor for nonalcoholic steatohepatitis: an adaptive, randomized, placebo-controlled phase 2a/b trial.

Arun J Sanyal, Patricia Lopez, Eric J Lawitz, Kathryn J Lucas, Juergen Loeffler, Won Kim, George B B Goh, Jee-Fu Huang, Carla Serra, Pietro Andreone and 17 more

Open access · hybridAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase II
In one paragraph

Trial report in Nature medicine, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 98 papers.

0numbers the graph read from it
0cells of the map it votes in
98citing papers in PubMed
31.8field-weighted citation impact, top 1% 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

98 citing papers in PubMed, 149 citations in OpenAlex.

  1. Trial
  2. Digital quantitation of bridging fibrosis and septa reveals changes in natural history and treatment not seen with conventional histology.Liver international : official journal of the International Association for the Study of the Liver · 2024
    Trial
  3. Exercise training improves serum biomarkers of liver fibroinflammation in patients with metabolic dysfunction-associated steatohepatitis.Liver international : official journal of the International Association for the Study of the Liver · 2024
    Trial
  4. Review
  5. Bile acid signaling in health and disease.Molecular biomedicine · 2026
    Review
  6. Review
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38 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

27 authors at 17 institutions in 8 countries.

Arun J SanyalVirginia Commonwealth University School of Medicine, Richmond, VA, USA. arun.sanyal@vcuhealth.org.ORCID http://orcid.org/0000-0001-8682-5748
Patricia LopezNovartis Pharma AG, Basel, Switzerland.
Eric J LawitzTexas Liver Institute, University of Texas Health, San Antonio, TX, USA.
Kathryn J LucasDiabetes and Endocrinology Consultants, Morehead City, NC, USA.
Juergen LoefflerNovartis Pharma AG, Basel, Switzerland.ORCID http://orcid.org/0000-0003-0609-7694
Won KimDivision of Gastroenterology and Hepatology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul Metropolitan Government Boramae Medical Center, Seoul, Republic of Korea.ORCID http://orcid.org/0000-0002-2926-1007
George B B GohDepartment of Gastroenterology and Hepatology, Singapore General Hospital, Singapore, Singapore.
Jee-Fu HuangHepatitis Centre and Hepatobiliary Division, Department of Internal Medicine, Kaohsiung Medical University Hospital, Kaohsiung City, Taiwan.ORCID http://orcid.org/0000-0002-2752-7051
Carla SerraDiagnostic and Therapeutic Interventional Ultrasound Unit, IRCCS, Azienda Ospedaliero-Universitaria, Bologna, Italy.
Pietro AndreoneUniversity of Modena and Reggio Emilia, Modena, Italy.ORCID http://orcid.org/0000-0002-4794-9809
Yi-Cheng ChenDepartment of Gastroenterology and Hepatology, Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Taoyuan, Taiwan.
Stanley H HsiaNational Research Institute, Los Angeles, CA, USA.
Vlad RatziuSorbonne Université, Assistance Publique-Hôpitaux de Paris, Hôpital Pitié Salpêtrière, Institute of Cardiometabolism and Nutrition (ICAN), Paris, France.ORCID http://orcid.org/0000-0002-6865-3791
Diego AizenbergCentro Medico Viamonte, Buenos Aires, Argentina.
Hiroshi TobitaShimane University Hospital, Izumo, Japan.
Aasim M SheikhGastrointestinal Specialists of Georgia, Marietta, GA, USA.ORCID http://orcid.org/0000-0002-4085-6474
John M VierlingAdvanced Liver Therapies, Baylor College of Medicine, Houston, TX, USA.
Yoon Jun KimSeoul National University College of Medicine and Liver Research Institute, Seoul, Korea.
Hideyuki HyogoJA Hiroshima General Hospital, Hiroshima, Japan.
Dean TaiHistoIndex Pte. Ltd, Singapore, Singapore.
Zachary GoodmanInova Fairfax Hospital, Falls Church, VA, USA.
Felicity SchaeferNovartis Pharmaceutical Corporation, East Hanover, NJ, USA.
Ian R I CarbarnsNovartis Pharma AG, Basel, Switzerland.
Sophie LamleNovartis Pharma AG, Basel, Switzerland.
Miljen MarticNovartis Pharma AG, Basel, Switzerland.ORCID http://orcid.org/0000-0002-0166-5421
Nikolai V NaoumovNovartis Pharma AG, Basel, Switzerland.
Clifford A BrassNovartis Pharmaceutical Corporation, East Hanover, NJ, USA.
Novartis (Switzerland) · CHNovartis (United States) · USSeoul National University · KRBaylor College of Medicine · USChang Gung University · TWGI Specialists of Georgia (United States) · USHiroshima General Hospital · JPHistoindex (Singapore) · SGInova Fairfax Hospital · USKaohsiung Medical University · TWNational Research Institute · USShimane University Hospital · JPSingapore General Hospital · SGSorbonne Université · FRThe University of Texas Health Science Center at San Antonio · USUniversity of Modena and Reggio Emilia · ITVirginia Commonwealth University · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The multimodal activities of farnesoid X receptor (FXR) agonists make this class an attractive option to treat nonalcoholic steatohepatitis. The safety and efficacy of tropifexor, an FXR agonist, in a randomized, multicenter, double-blind, three-part adaptive design, phase 2 study, in patients with nonalcoholic steatohepatitis were therefore assessed. In Parts A + B, 198 patients were randomized to receive tropifexor (10-90 μg) or placebo for 12 weeks. In Part C, 152 patients were randomized to receive tropifexor 140 µg, tropifexor 200 µg or placebo (1:1:1) for 48 weeks. The primary endpoints were safety and tolerability to end-of-study, and dose response on alanine aminotransferase (ALT), aspartate aminotransferase (AST) and hepatic fat fraction (HFF) at week 12. Pruritus was the most common adverse event in all groups, with a higher frequency in the 140- and 200-µg tropifexor groups. Decreases from baseline in ALT and HFF were greater with tropifexor versus placebo at week 12, with a relative decrease in least squares mean from baseline observed with all tropifexor doses for ALT (tropifexor 10-90-μg dose groups ranged from -10.7 to -16.5 U l

Indexed as

Non-alcoholic Fatty Liver DiseaseBenzothiazolesDouble-Blind MethodHumansIsoxazolesTreatment OutcomeBenzothiazolesIsoxazolestropifexor

Identifiers

PMID36797481
PMCPMC9941046
OpenAlexW4321077653

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.