Evidence mapPaperPMID 40080694Full record

Trial reportThe Journal of clinical endocrinology and metabolism2025

Efficacy and Safety of Obeticholic Acid for Treating Hepatic Steatosis in Patients With Familial Partial Lipodystrophy.

Abhimanyu Garg, Chandna Vasandani, Xilong Li, Claudia Quittner, Takeshi Yokoo

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical endocrinology and metabolism, 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. Trial
  2. Article
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

5 authors.

Abhimanyu GargSection of Nutrition and Metabolic Diseases, Division of Endocrinology, Department of Internal Medicine, Center for Human Nutrition, UT Southwestern Medical Center, Dallas, TX 75390-8537, USA.ORCID 0000-0001-7209-6986
Chandna VasandaniSection of Nutrition and Metabolic Diseases, Division of Endocrinology, Department of Internal Medicine, Center for Human Nutrition, UT Southwestern Medical Center, Dallas, TX 75390-8537, USA.ORCID 0000-0003-4014-2831
Xilong LiPeter O'Donnell Jr. School of Public Health, UT Southwestern Medical Center, Dallas, TX 75390-9066, USA.ORCID 0000-0002-1833-6077
Claudia QuittnerSection of Nutrition and Metabolic Diseases, Division of Endocrinology, Department of Internal Medicine, Center for Human Nutrition, UT Southwestern Medical Center, Dallas, TX 75390-8537, USA.
Takeshi YokooDepartment of Radiology, UT Southwestern Medical Center, Dallas, TX 75390-9085, USA.ORCID 0000-0002-5092-6931

Funding

Intercept PharmaceuticalsNCATS NIH HHS (UL1TR001105)
6 · The paper itself

Abstract

contextPatients with familial partial lipodystrophy (FPLD) have increased risk of hepatic steatosis and its complications, for which there is no approved therapy.

objectiveThis work aimed to investigate the efficacy and safety of obeticholic acid (OCA), a farnesoid X receptor agonist, for reducing hepatic steatosis in patients with FPLD.

methodsA randomized, double-blind, placebo-controlled, crossover trial was conducted at an academic referral center. Ten women (age 19-60 years) with the Dunnigan variety of FPLD (FPLD2), harboring pathogenic heterozygous variants in the lamin A/C gene and hepatic steatosis (liver fat >5.6% by proton-density fat fraction mapping by magnetic resonance imaging), were included. Intervention included OCA 25 mg daily vs matched placebo for 4 months each with a 4-month washout period in between. The primary end point variable was liver fat. Secondary end point variables were serum triglycerides (TGs) and transaminase levels.

resultsAll patients completed the trial. OCA therapy caused significant (39.6%) reduction in liver fat as compared to placebo (median liver fat [minimum-maximum]; 6.4% [2.4%-18.0%] vs 10.6% [3.4%-29.3%], respectively; P value for treatment × month interaction = .03). There were no significant differences in serum TGs or transaminase levels during OCA and placebo therapy. Overall, OCA was well tolerated except for itching in 4 patients compared to 2 on placebo. OCA, as compared to placebo, caused 24% increase in serum low-density lipoprotein cholesterol (mean 129 mg/dL vs 104 mg/dL, respectively; P = .0016).

conclusionOCA is safe and effective in lowering hepatic TG levels in patients with FPLD2.

Indexed as

Chenodeoxycholic AcidFatty LiverLipodystrophy, Familial PartialAdultCross-Over StudiesDouble-Blind MethodFemaleHumansLiverMiddle AgedTreatment OutcomeTriglyceridesYoung AdultChenodeoxycholic Acidobeticholic acidTriglyceridesDunnigan varietyfamilial partial lipodystrophyhepatic steatosislamin A/Cobeticholic acidtransaminasetriglycerides

Identifiers

PMID40080694
PMCPMC12527461

What Socratic 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 Socratic graph.