Evidence map›Paper›PMID 33289350›Full record

Trial reportDiabetes, obesity & metabolism2021

Inhibition of fatty acid synthase with FT-4101 safely reduces hepatic de novo lipogenesis and steatosis in obese subjects with non-alcoholic fatty liver disease: Results from two early-phase randomized trials.

Carine Beysen, Patricia Schroeder, Eric Wu, Julie Brevard, Maria Ribadeneira, Wei Lu, Kiran Dole, Terry O'Reilly, Linda Morrow, Marcus Hompesch and 4 more

Open access · hybridAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Diabetes, obesity & metabolism, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 35 papers.

0numbers the graph read from it
0cells of the map it votes in
35citing papers in PubMed
4.7field-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.

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

35 citing papers in PubMed, 52 citations in OpenAlex.

  1. Trial
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  3. Review
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  5. New Horizons in Metabolic Health: Unveiling the Future of Drug Discovery and Development.Endocrine, metabolic & immune disorders drug targets · 2026
    Review
  6. Targeting Metabolism: Innovative Therapies for MASLD Unveiled.International journal of molecular sciences · 2025
    Review
  7. Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. Review
  13. Article
  14. Review
  15. Article
  16. Article
  17. Ubiquitination and Metabolic Disease.Advances in experimental medicine and biology · 2024
    Review
  18. Article
  19. Review
  20. 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

14 authors at 6 institutions in 2 countries.

Carine BeysenFluxBio, San Mateo, California.ORCID 0000-0002-2259-0932
Patricia SchroederForma Therapeutics, Watertown, Massachusetts.
Eric WuForma Therapeutics, Watertown, Massachusetts.
Julie BrevardForma Therapeutics, Watertown, Massachusetts.
Maria RibadeneiraForma Therapeutics, Watertown, Massachusetts.
Wei LuForma Therapeutics, Watertown, Massachusetts.
Kiran DoleForma Therapeutics, Watertown, Massachusetts.
Terry O'ReillyCelerion, Tempe, Arizona.
Linda MorrowProSciento Inc, Chula Vista, California.
Marcus HompeschProSciento Inc, Chula Vista, California.ORCID 0000-0001-5867-2131
Marc K HellersteinDepartment of Nutritional Sciences and Toxicology, University of California, Berkeley, Berkeley, California.
Kelvin LiDepartment of Nutritional Sciences and Toxicology, University of California, Berkeley, Berkeley, California.
Lars JohanssonAntaros Medical, Mölndal, Sweden.
Patrick F KellyForma Therapeutics, Watertown, Massachusetts.
Forma Therapeutics (United States) · USPrecision Research Institute · USUniversity of California, Berkeley · USAntaros Medical (Sweden) · SECelerion (United States) · USFluxion Biosciences (United States) · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimsTo assess the therapeutic potential of fatty acid synthase (FASN) inhibition with FT-4101, a potent, selective, orally bioavailable, small-molecule by (a) evaluating the dose-response of single FT-4101 doses (3, 6 and 9 mg) on hepatic de novo lipogenesis (DNL) in healthy participants (Study 1) and (b) demonstrating the safety, tolerability and efficacy on hepatic steatosis after 12 weeks of FT-4101 dosing in patients with non-alcoholic fatty liver disease (NAFLD; Study 2). MATERIALS AND

methodsIn Study 1, three sequential cohorts of healthy men (n = 10/cohort) were randomized to receive a single dose of FT-4101 (n = 5/cohort) or placebo (n = 5/cohort) followed by crossover dosing after 7 days. Hepatic DNL was assessed during fructose stimulation from

resultsSingle and repeat dosing of FT-4101 were safe and well tolerated. Single FT-4101 doses inhibited hepatic DNL dose-dependently. Twelve weeks of 3 mg FT-4101 treatment improved hepatic steatosis and inhibited hepatic DNL. Decreases in sebum sapienate content with FT-4101 at week 11 were not significant compared to placebo and rebounded at week 12. Biomarkers of liver function, glucose and lipid metabolism were unchanged.

conclusionsInhibition of FASN with 3 mg FT-4101 safely reduces hepatic DNL and steatosis in NAFLD patients.

Indexed as

Non-alcoholic Fatty Liver DiseaseFatty Acid SynthasesFemaleHumansLipogenesisLiverMaleObesityFatty Acid Synthasesdrug developmentdrug mechanismfatty liver diseasepharmacodynamicsphase I−II studyrandomized trial

Identifiers

PMID33289350
PMCPMC7898808
OpenAlexW3106636817

What OpenQuestion holds

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LicenceCC BY-NC-ND
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Registered trials

None linked

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.