Evidence map›Paper›PMID 35291351›Full record

Trial reportMed (New York, N.Y.)2021

Metreleptin therapy for nonalcoholic steatohepatitis: Open-label therapy interventions in two different clinical settings.

Baris Akinci, Angela Subauste, Nevin Ajluni, Nazanene H Esfandiari, Rasimcan Meral, Adam H Neidert, Akin Eraslan, Rita Hench, Diana Rus, Barbara McKenna and 9 more

Open access · bronzeAbstract readClinical TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Med (New York, N.Y.), 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
2.9field-weighted citation impact, top 9% 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

13 citing papers in PubMed, 1 synthesis or guideline pooled it, 28 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Research Progress on Leptin in Metabolic Dysfunction-associated Fatty Liver Disease.Journal of clinical and translational hepatology · 2025
    Review
  5. Review
  6. Article
  7. Observational
  8. Review
  9. Review
  10. Article
  11. Article
  12. Review
  13. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

19 authors at 3 institutions in 2 countries.

Baris AkinciDivision of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Angela SubausteDivision of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Nevin AjluniDivision of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Nazanene H EsfandiariDivision of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Rasimcan MeralDivision of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Adam H NeidertDivision of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Akin EraslanDivision of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Rita HenchDivision of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Diana RusDivision of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Barbara McKennaDepartment of Pathology, University of Michigan, Ann Arbor, MI, USA.
Hero K HussainDepartment of Radiology, University of Michigan, Ann Arbor, MI, USA.
Thomas L ChenevertDepartment of Radiology, University of Michigan, Ann Arbor, MI, USA.
Marwan K TayehDepartments of Pediatrics, University of Michigan, Ann Arbor, MI, USA.
Amit R RupaniDepartments of Pediatrics, University of Michigan, Ann Arbor, MI, USA.
Jeffrey W InnisDepartments of Pediatrics, University of Michigan, Ann Arbor, MI, USA.
Christos S MantzorosEndocrinology, Diabetes and Metabolism, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, MA, USA.
Hari S ConjeevaramDivision of Gastroenterology, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Charles L BurantDivision of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
Elif A OralDivision of Metabolism, Endocrinology and Diabetes, Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.
University of Michigan · USBeth Israel Deaconess Medical Center · USDokuz Eylül University · TR

Funding

Michigan Institute for Clinical and Health Research (MICHR)UL1TR002240 · NCATS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI LUMENG, JULIE C, MASHOUR, GEORGE ALEXANDER · 2017 to 2022
$54.9M
Michigan Institute for Clinical and Health Research (MCHR)UL1TR000433 · NCATS · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MASHOUR, GEORGE ALEXANDER · 2012 to 2016
$49.9M
ZINC GLUCONATE GLYCINE LOZENGES &VITAMIN C EFFECTS ON COMMON COLDM01RR000042 · NCRR · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ELSTROM, REBECCA L · 1985 to 2007
$40.8M
PUBLIC HEALTH DEMONSTRATIONP60DK020572 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI MYERS, MARTIN G · 1985 to 2012
$26.5M
University of Michigan Center for Gastrointestinal ResearchP30DK034933 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI OMARY, BISHR · 1986 to 2021
$22.5M
Pilot and Feasibility (P and F) ProgramP30DK089503 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI Kanakadurga Singer · 2010 to 2026
$20.3M
Statistics and Bioinformatics Core - WangU24DK097153 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI BURANT, CHARLES F · 2012 to 2017
$10.1M
Effects of recombinant human leptin in nonalcoholic fatty liver disease (NAFLD)R01DK088114 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI CONJEEVARAM, HARI S, ORAL, ELIF ARIOGLU · 2011 to 2015
$1.7M
RECOMBINANT LEPTIN THERAPY FOR TREATMENT OF NASHR03DK074488 · NIDDK · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI ORAL, ELIF ARIOGLU · 2006 to 2007
$300k
NCATS NIH HHS UL1 TR000433NCATS NIH HHS UL1 TR002240NCRR NIH HHS M01 RR000042NIDDK NIH HHS P30 DK034933NIDDK NIH HHS P30 DK089503NIDDK NIH HHS P60 DK020572NIDDK NIH HHS R01 DK088114NIDDK NIH HHS R03 DK074488NIDDK NIH HHS U24 DK097153
6 · The paper itself

Abstract

backgroundRecombinant leptin therapy reverses nonalcoholic steatohepatitis (NASH) in leptin-deficient lipodystrophy. We inquired if leptin therapy would improve nonalcoholic steatohepatitis in more common forms of this heterogeneous condition.

methodsNine male patients with relative leptin deficiency (level < 25th percentile of body mass index- and gender-matched United States population) and biopsy-proven NASH and 23 patients with partial lipodystrophy and NASH were recruited for two distinctive open-label trials. Participants received leptin therapy in the form of metreleptin for 12 months. The primary endpoints were the global nonalcoholic steatohepatitis scores from paired liver biopsies scored blindly.

findingsOf 9 participants recruited in the relative leptin deficiency treatment study, 7 completed 12-months of therapy. Mean global NASH scores were reduced from 8 ± 3 to 5 ± 2 (range: from 1 to 6,

conclusionOur findings show that patients with NASH associated with both relative leptin deficiency and partial lipodystrophy have reductions in hepatic steatosis and injury in response to exogenous leptin therapy. Moreover, leptin deficiency may have regulatory effects in mediating fat deposition and ensuing injury in the liver.

Indexed as

LipodystrophyNon-alcoholic Fatty Liver DiseaseHumansLeptinMaleLeptinmetreleptinFatty Liver DiseaseInsulin ResistanceLeptinObesityPartial Lipodystrophy

Identifiers

PMID35291351
PMCPMC8920072
OpenAlexW3163310998

What OpenQuestion holds

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Read underepoch 390

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.