Evidence map›Paper›PMID 29325236›Full record

Trial reportThe Journal of clinical psychiatry

Treatment With a Ghrelin Agonist in Outpatient Women With Anorexia Nervosa: A Randomized Clinical Trial.

Pouneh K Fazeli, Elizabeth A Lawson, Alexander T Faje, Kamryn T Eddy, Hang Lee, Fred T Fiedorek, Anne Breggia, Ildiko M Gaal, Rebecca DeSanti, Anne Klibanski

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of clinical psychiatry. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01642550 (A Phase 2, Investigator-Initiated, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa), which is not on this map. Cited by 37 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 14% 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.

NCT01642550 phase2completednot on this map

A Phase 2, Investigator-Initiated, Randomized, Double-blind, Placebo-controlled Pilot Study to Evaluate the Safety and Efficacy of RM-131 Administered to Females With Anorexia Nervosa

TypeinterventionalSponsorMotus Therapeutics, Inc.Ran2012 to 2015Enrolled20ConditionsAnorexia NervosaArmsRM-131, Placebo
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 1 synthesis or guideline pooled it, 70 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Nutritional state-dependent changes in subcortical limbic structures in anorexia nervosa are linked to leptin, ghrelin, and neurofilament light.Neuropsychopharmacology : official publication of the American College of Neuropsychopharmacology · 2026
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  16. Neuroendocrine adaptations to starvation.Psychoneuroendocrinology · 2023
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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

10 authors at 2 institutions in 1 country.

Pouneh K FazeliNeuroendocrine Unit, Bulfinch 457B, Massachusetts General Hospital, Boston, MA 02114. pkfazeli@partners.org.
Elizabeth A LawsonNeuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.
Alexander T FajeNeuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.
Kamryn T EddyHarvard Medical School, Boston, Massachusetts, USA.
Hang LeeHarvard Medical School, Boston, Massachusetts, USA.
Fred T FiedorekMotus Therapeutics, Boston, Massachusetts, USA.
Anne BreggiaMaine Medical Center, Scarborough, Maine, USA.
Ildiko M GaalNeuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.
Rebecca DeSantiNeuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.
Anne KlibanskiNeuroendocrine Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.
Harvard University · USMassachusetts General Hospital · US

Funding

Harvard Clinical and Translational Science CenterUL1TR001102 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2013 to 2017
$106.2M
ROLE OF DIETARY CONSTITUENTS ON GENE EXPRESSION IN INTESTINAL EPITHELIUMP30DK040561 · NIDDK · MASSACHUSETTS GENERAL HOSPITAL · PI Elizabeth Austen Lawson, Takara Leah Stanley · 1994 to 2026
$31.6M
Harvard Clinical and Translational Science Center (UL1)UL1TR000170 · NCATS · HARVARD MEDICAL SCHOOL · PI NADLER, LEE MARSHALL · 2012 to 2013
$31.4M
NCATS NIH HHS UL1 TR000170NCATS NIH HHS UL1 TR001102NIDDK NIH HHS P30 DK040561
6 · The paper itself

Abstract

objectiveTo assess the effects of relamorelin-an agonist of the appetite-stimulating hormone ghrelin, which has effects on gastric emptying-on (1) weight gain and (2) gastric emptying in women with anorexia nervosa.

methodsIn a randomized, double-blind, placebo-controlled design, the effects of the ghrelin agonist relamorelin were studied in 22 outpatient women with anorexia nervosa, diagnosed using DSM-5 criteria. The study was conducted at the Massachusetts General Hospital Clinical Research Center between March 11, 2013, and February 26, 2015. Ten participants were randomly assigned to relamorelin 100 μg subcutaneously daily (mean ± SEM age: 28.9 ± 2.4 y), and 12 were randomly assigned to placebo (28.9 ± 1.9 y). We measured changes in weight and gastric emptying time using a gastric emptying breath test (GEBT) for relamorelin versus placebo after 4 weeks of treatment.

resultsAt baseline, subjects did not differ in weight, plasma ghrelin levels, or gastric emptying time. Three subjects randomized to relamorelin stopped use of the study medication due to reported feelings of increased hunger. After 4 weeks, there was a trend toward an increase in weight in participants randomized to relamorelin (mean ± SEM change: 0.86 ± 0.40 kg) compared to placebo (0.04 ± 0.28 kg; P = .07), and gastric emptying time was significantly shorter in patients taking relamorelin (median [interquartile range]: 58.0 [51.0, 78.0] minutes) compared to placebo (85.0 [75.8,100.5] minutes; P = .03).

conclusionsTreatment with a ghrelin agonist in women with anorexia nervosa significantly decreases gastric emptying time, leads to a trend in weight gain after only 4 weeks, and is well-tolerated. Further study is necessary to determine the long-term safety and efficacy of a ghrelin agonist in the treatment of anorexia nervosa.

trial registrationClinicalTrials.gov identifier: NCT01642550.

Indexed as

AdultAnorexia NervosaAppetite StimulantsDouble-Blind MethodFemaleGastric EmptyingGhrelinHumansOligopeptidesOutpatientsTime FactorsTreatment OutcomeWeight GainYoung AdultAppetite StimulantsGhrelinOligopeptidesrelamorelin

Identifiers

PMID29325236
PMCPMC6908430
OpenAlexW2778633687

What OpenQuestion holds

Textmetadata
LicenceTDM
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 OpenQuestion graph.