Evidence map›Paper›PMID 41479524›Full record

Trial reportWorld journal of hepatology2025

Phase III, multicenter, randomized, double-blind, placebo-controlled study of norursodeoxycholic acid in metabolic dysfunction-associated steatotic liver disease patients.

Veerendra Kumar Panuganti, Chandrasekhar Varma Alluri, Javeed Mohammad, Mamatha Reddy Dundigalla, Pavan Kumar Madala, Sanyasirao Kssvv, Althaf Shaik

Abstract readClinical Trial
In one paragraph

Trial report in World journal of hepatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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

2 citing papers in PubMed.

  1. Nor-ursodeoxycholic acid in hepatobiliary diseases: A narrative review.World journal of gastrointestinal pharmacology and therapeutics · 2026
    Review
  2. Review
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

7 authors.

Veerendra Kumar PanugantiClinical Affair Division, Shilpa Medicare Limited, Hyderabad 500076, Telangāna, India. veerendrap.frd@shilpamedicare.com.
Chandrasekhar Varma AlluriMedical Affairs Department, Shilpa Medicare Limited, Hyderabad 500076, Telangāna, India.
Javeed MohammadClinical Affair Division, Shilpa Medicare Limited, Hyderabad 500076, Telangāna, India.
Mamatha Reddy DundigallaMedical Affairs Department, Shilpa Medicare Limited, Hyderabad 500076, Telangāna, India.
Pavan Kumar MadalaBioanalytical Laboratory, Shilpa Medicare Limited, Hyderabad 500076, Telangāna, India.
Sanyasirao KssvvClinical Affair Division, Shilpa Medicare Limited, Hyderabad 500076, Telangāna, India.
Althaf ShaikClinical Affair Division, Shilpa Medicare Limited, Hyderabad 500076, Telangāna, India.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe norursodeoxycholic acid (norUDCA), a side chain-shortened derivative of ursodeoxycholic acid, exhibits unique pharmacological properties that may benefit patients with metabolic dysfunction-associated steatotic liver disease (MASLD).

aimTo evaluate the efficacy, safety, and tolerability of norUDCA 1500 mg compared to placebo in the patients with MASLD.

methodsThis phase III, randomized, double-blind, multi-centric, placebo-controlled trial enrolled patients with MASLD, and were randomized in 2:1 ratio to receive either norUDCA 1500 mg or placebo for 24 weeks. Efficacy and safety were rigorously evaluated through clinical, biochemical, and imaging assessments. Primary endpoints assessed alanine aminotransferase (ALT) normalization and improvement in liver stiffness (FibroScan

resultsOf 165 randomized patients, 110 received norUDCA and 55 placebos. At week 12, ALT normalization was achieved in 89% of norUDCA-treated group compared to 76% of placebo-treated group (

conclusionNorUDCA 1500 mg demonstrated clinically meaningful therapeutic efficacy in patients with MASLD, accompanied by consistently favorable safety profile.

Indexed as

24-norursodeoxycholic acidFatty liverFibrosisLiver diseasesMetabolic dysfunction-associated steatotic liver diseaseNonalcoholic fatty liver diseaseSteatosis

Identifiers

PMID41479524
PMCPMC12754511

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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.