Evidence map›Paper›PMID 28760384›Full record

Trial reportGastroenterology2017

Efficacy and Safety of Relamorelin in Diabetics With Symptoms of Gastroparesis: A Randomized, Placebo-Controlled Study.

Michael Camilleri, Richard W McCallum, Jan Tack, Sharon C Spence, Keith Gottesdiener, Fred T Fiedorek

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Gastroenterology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02357420 (A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis), which is not on this map. Cited by 69 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
69citing papers in PubMed, 7 pooled it
–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.

NCT02357420 phase2completednot on this map

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of RM-131 Administered to Patients With Vomiting Symptoms and Moderate to Severe Diabetic Gastroparesis

TypeinterventionalSponsorAllerganRan2015 to 2016Enrolled393ConditionsDiabetes Mellitus, Diabetes Mellitus Complications, GastroparesisArmsRelamorelin, Placebo
3 · Its place in the literature

Who cites it

69 citing papers in PubMed, 7 syntheses or guidelines pooled it.

  1. Guideline
  2. Pooled it
  3. Pooled it
  4. Guideline
  5. Pooled it
  6. Pooled it
  7. Pooled it
  8. A Randomized, Controlled Trial of Efficacy and Safety of Cannabidiol in Idiopathic and Diabetic Gastroparesis.Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association · 2023
    Trial
  9. Trial
  10. Article
  11. Review
  12. Progress in Gastroparesis Management: From Pharmacotherapy to Interventional Treatments.JGH open : an open access journal of gastroenterology and hepatology · 2026
    Review
  13. Review
  14. Review
  15. Utility of aNeurogastroenterology and motility · 2025
    Article
  16. Review
  17. Pharmacologic treatments for gastroparesis.Pharmacological reviews · 2025
    Review
  18. Review
  19. Article
  20. Review

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

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

6 authors.

Michael CamilleriMayo Clinic, Rochester, Minnesota. Electronic address: camilleri.michael@mayo.edu.
Richard W McCallumDepartment of Internal Medicine, Texas Tech University Health Sciences Center, El Paso, Texas.
Jan TackUniversity Hospital, Leuven, Belgium.
Sharon C SpenceMotus Therapeutics, Boston, Massachusetts.
Keith GottesdienerMotus Therapeutics, Boston, Massachusetts.
Fred T FiedorekMotus Therapeutics, Boston, Massachusetts.

Funding

Physiological Characterization and Data Integration CoreP01DK068055 · NIDDK · MAYO CLINIC ROCHESTER · PI BHARUCHA, ADIL E. · 2004 to 2019
$23.8M
Temple University Gastroparesis Clinical CenterU01DK073975 · NIDDK · TEMPLE UNIV OF THE COMMONWEALTH · PI HENRY PAUL PARKMAN · 2006 to 2026
$7.4M
Pharmacogenomics of Gastric Function &Weight in ObesityR01DK067071 · NIDDK · MAYO CLINIC ROCHESTER · PI CAMILLERI, MICHAEL L. · 2004 to 2020
$4.7M
Pharmacodynamics, Pharmacogenetics, Clinical Efficacy and Safety of Cannabidiol for Gastroparesis and Functional DyspepsiaR01DK122280 · NIDDK · MAYO CLINIC ROCHESTER · PI CAMILLERI, MICHAEL L. · 2019 to 2022
$1.5M
NIDDK NIH HHS P01 DK068055NIDDK NIH HHS R01 DK067071NIDDK NIH HHS R01 DK122280NIDDK NIH HHS U01 DK073975
6 · The paper itself

Abstract

BACKGROUND &

aimsGastroparesis is a complication of diabetes with few treatment options. Relamorelin (also referred to as RM-131) is a selective, prokinetic agonist of ghrelin. We aimed to evaluate the efficacy of relamorelin on symptoms and gastric emptying (GE) in a 12-week, phase 2B study of diabetic patients with moderate to severe gastroparesis symptoms (DG).

methodsWe performed a study of 393 patients with DG (37.7% male; 9.9% with type 1 diabetes; median age, 58.2 years [range 20-76]; median body mass index, 31.4 kg/m

resultsPatients given relamorelin had a 75% reduction in vomiting frequency compared with baseline, but this difference was not significant compared with the placebo group. All 4 symptoms of DG (composite or individual symptoms) were significantly reduced over the 12-week study period in all 3 relamorelin dose groups compared with the placebo group (all P < .05, based on longitudinal analysis over 12 weeks). Relamorelin significantly accelerated GE from baseline compared with placebo (by 12%, P < .05 for the 10 μg and 30 μg groups; P = .051 for the 100 μg group). Dose-related worsening of glycemic control was noted in 14.5% of patients who received relamorelin; some required insulin or other diabetes drug dosage adjustments.

conclusionsIn a phase 2B randomized trial of patients with moderate to severe DG, relamorelin significantly reduced core symptoms of DG and overall composite score compared with placebo, accelerated GE, and was generally safe and well tolerated. ClinicalTrials.gov Identifier: NCT02357420.

Indexed as

Abdominal PainAdultAgedDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2EuropeFemaleGastric EmptyingGastrointestinal AgentsGastroparesisHumansIsraelMaleMiddle AgedOligopeptidesRecovery of FunctionGastrointestinal AgentsOligopeptidesrelamorelinBloatingFullnessNauseaVomiting

Identifiers

PMID28760384
PMCPMC5670003

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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.