Evidence map›Paper›PMID 32794259›Full record

Trial reportHepatology (Baltimore, Md.)2021

The Commensal Microbe Veillonella as a Marker for Response to an FGF19 Analog in NASH.

Rohit Loomba, Lei Ling, Duy M Dinh, Alex M DePaoli, Hsiao D Lieu, Stephen A Harrison, Arun J Sanyal

Registry-linked trialOpen access · hybridAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Hepatology (Baltimore, Md.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02443116 (A Phase 2, Randomized, Double-blind, Placebo-controlled Study With Additional Open-label, Single-blind and Placebo-controlled Cohorts to Assess the Safety, Tolerability, and Efficacy of NGM282 in Patients With Nonalcoholic Steatohepatitis), which is not on this map. Cited by 63 papers.

0numbers the graph read from it
0cells of the map it votes in
63citing papers in PubMed
4.4field-weighted citation impact, top 4% 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.

NCT02443116 phase2completednot on this map

A Phase 2, Randomized, Double-blind, Placebo-controlled Study With Additional Open-label, Single-blind and Placebo-controlled Cohorts to Assess the Safety, Tolerability, and Efficacy of NGM282 in Patients With Nonalcoholic Steatohepatitis

TypeinterventionalSponsorNGM Biopharmaceuticals, IncRan2015 to 2020Enrolled254ConditionsNonalcoholic Steatohepatitis (NASH)ArmsNGM282, Placebo
3 · Its place in the literature

Who cites it

63 citing papers in PubMed, 91 citations in OpenAlex.

  1. Trial
  2. Review
  3. Trending ileal microbiome dysbiosis over time as an early assessment of intestinal transplant rejection risk.American journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons · 2026
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  15. Emerging liver infection ofAnnals of medicine and surgery (2012) · 2024
    Article
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  19. Article
  20. Article

3 more citing papers are in PubMed but not listed here.

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 at 5 institutions in 2 countries.

Rohit LoombaNAFLD Research Center, University of California, San Diego, La Jolla, CA.ORCID 0000-0002-4845-9991
Lei LingClinical Research, NGM Biopharmaceuticals Inc., South San Francisco, CA.
Duy M DinhDiversigen, Inc., Houston, TX.
Alex M DePaoliClinical Research, NGM Biopharmaceuticals Inc., South San Francisco, CA.
Hsiao D LieuClinical Research, NGM Biopharmaceuticals Inc., South San Francisco, CA.
Stephen A HarrisonRadcliffe Department of Medicine, University of Oxford, London, United Kingdom.
Arun J SanyalDepartment of Internal Medicine, Virginia Commonwealth University, Richmond, VA.ORCID 0000-0001-8682-5748
NGM Biopharmaceuticals (United States) · USDiversitech (United States) · USUniversity of California San Diego · USUniversity of Oxford · GBVirginia Commonwealth University · US

Funding

Yeast Genetics and Stress Response Genes-BiomedicalP42ES010337 · NIEHS · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI TUKEY, ROBERT H · 2000 to 2022
$69.8M
San Diego Digestive Diseases Research CenterP30DK120515 · NIDDK · UNIVERSITY OF CALIFORNIA, SAN DIEGO · PI LARS ECKMANN, Bernd G. Schnabl · 2019 to 2026
$10.8M
NIDDK NIH HHS P30 DK120515NIEHS NIH HHS P42 ES010337
6 · The paper itself

Abstract

BACKGROUND AND

aimsThe composition of the human gut microbiota is linked to health and disease, and knowledge of the impact of therapeutics on the microbiota is essential to decipher their biological roles and to gain new mechanistic insights. Here we report the effect of aldafermin, an analog of the gut hormone FGF19, versus placebo on the gut microbiota in a prospective, phase 2 study in patients with NASH. APPROACH AND

resultsA total of 176 patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) (nonalcoholic fatty liver disease activity score ≥ 4), fibrosis (F1-F3 by NASH Clinical Research Network criteria), and elevated liver fat content (≥ 8% by magnetic resonance imaging-proton density fat fraction) received 0.3 mg (n = 23), 1 mg (n = 49), 3 mg (n = 49), and 6 mg (n = 28) aldafermin or placebo (n = 27) for 12 weeks. Stool samples were collected on day 1 and week 12 and profiled using 16S ribosomal RNA gene sequencing; 122 patients had paired stool microbiome profiles at both day 1 and week 12. Overall, the state of the gut microbial community was distinctly stable in patients treated with aldafermin, with all major phyla and genera unaltered during therapy. Patients treated with aldafermin showed a significant, dose-dependent enrichment in the rare genus Veillonella, a commensal microbe known to have lactate-degrading and performance-enhancing properties, which correlated with changes in serum bile acid profile.

conclusionsVeillonella may be a bile acid-sensitive bacteria whose enrichment is enabled by aldafermin-mediated suppression of bile acid synthesis and, in particular, decreases in toxic bile acids. This study provides an integrated analysis of gut microbiome, serum bile acid metabolome, imaging, and histological measurements in clinical trials testing aldafermin for NASH. Our results provide a better understanding of the intricacies of microbiome-host interactions (clinicaltrials.gov trial No. NCT02443116).

Indexed as

Gastrointestinal MicrobiomeAdultBile Acids and SaltsBiomarkersDysbiosisFecesFemaleFibroblast Growth FactorsFibrosisHumansLiverMaleMiddle AgedNon-alcoholic Fatty Liver DiseaseProspective StudiesVeillonellaaldaferminBile Acids and SaltsBiomarkersFibroblast Growth Factors

Identifiers

PMID32794259
PMCPMC7898628
OpenAlexW3049718907

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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 Socratic graph.