Evidence map›Paper›PMID 30421844›Full record

Trial reportObesity (Silver Spring, Md.)2019

A Randomized, Double-Blind, Placebo-Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss.

Frank L Greenway, Louis J Aronne, Anne Raben, Arne Astrup, Caroline M Apovian, James O Hill, Lee M Kaplan, Ken Fujioka, Erika Matejkova, Stepan Svacina and 14 more

Erratum issuedAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Obesity (Silver Spring, Md.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 48 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
48citing papers in PubMed, 1 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.

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

48 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. American Association of Clinical Endocrinology Clinical Practice Guideline: Developing a Diabetes Mellitus Comprehensive Care Plan-2022 Update.Endocrine practice : official journal of the American College of Endocrinology and the American Association of Clinical Endocrinologists · 2022
    Guideline
  2. Trial
  3. Trial
  4. Trial
  5. Trial
  6. Article
  7. Review
  8. Review
  9. Palmitoylethanolamide in Human and Animal Obesity.Molecules (Basel, Switzerland) · 2026
    Review
  10. Article
  11. Review
  12. Article
  13. Review
  14. Endobariatric systems: Strategic integration of endoscopic therapies in the management of obesity.Indian journal of gastroenterology : official journal of the Indian Society of Gastroenterology · 2024
    Review
  15. A Guideline-Directed Approach to Obesity Treatment.Diabetes spectrum : a publication of the American Diabetes Association · 2024
    Article
  16. Review
  17. Article
  18. Article
  19. Obesity Management in Adults: A Review.JAMA · 2023 · on this map
    Review
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

24 authors.

Frank L GreenwayPennington Biomedical Research Center of the Louisiana State University System, Baton Rouge, Louisiana, USA.ORCID 0000-0002-1766-6111
Louis J AronneWeill Cornell Medicine Comprehensive Weight Control Center, New York, New York, USA.
Anne RabenDepartment of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg C, Denmark.
Arne AstrupDepartment of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen, Frederiksberg C, Denmark.
Caroline M ApovianDepartment of Medicine, Endocrinology, Diabetes, and Nutrition, Boston University School of Medicine, Boston, Massachusetts, USA.
James O HillDepartment of Pediatrics and Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
Lee M KaplanObesity, Metabolism, and Nutrition Institute and Gastrointestinal Unit, Massachusetts General Hospital, Boston, Massachusetts, USA.
Ken FujiokaScripps Clinic Del Mar, San Diego, California, USA.
Erika MatejkovaHealth & Care, sro., Prague, Czech Republic.
Stepan SvacinaThird Internal Clinic, Charles University, Prague, Czech Republic.
Livio LuziDepartment of Endocrinology and Metabolism, Policlinico San Donato, University of Milan, Milan, Italy.
Lucio GnessiExperimental Medicine Department, Sapienza University of Rome, Rome, Italy.
Santiago Navas-CarreteroCenter for Nutrition Research, University of Navarra, Pamplona, Spain.
J Alfredo MartinezCenter for Nutrition Research, University of Navarra, Pamplona, Spain.
Christopher D StillCenter for Nutrition and Weight, Geisinger Obesity Institute, Danville, Pennsylvania, USA.
Alessandro SanninoGelesis, Inc., Boston, Massachusetts, USA.
Cosimo SaponaroGelesis, Inc., Boston, Massachusetts, USA.
Christian DemitriGelesis, Inc., Boston, Massachusetts, USA.
Lorien E UrbanGelesis, Inc., Boston, Massachusetts, USA.
Harry LeiderGelesis, Inc., Boston, Massachusetts, USA.
Elaine ChiquetteGelesis, Inc., Boston, Massachusetts, USA.
Eyal S RonGelesis, Inc., Boston, Massachusetts, USA.
Yishai ZoharGelesis, Inc., Boston, Massachusetts, USA.
Hassan M HeshmatiGelesis, Inc., Boston, Massachusetts, USA.ORCID 0000-0002-5805-5085

Funding

Tracking & Evaluation CoreU54GM104940 · NIGMS · LSU PENNINGTON BIOMEDICAL RESEARCH CTR · PI JUDD E SHELLITO · 2012 to 2026
$69.1M
PILOT STUDY--SUBSTRATE METABOLISM IN EXTREMELY LOW BIRTH WEIGHT INFANTSP30DK048520 · NIDDK · UNIVERSITY OF COLORADO DENVER · PI Edward L Melanson · 1995 to 2026
$32.6M
NIGMS NIH HHS U54 GM104940
6 · The paper itself

Abstract

objectiveThis study aims to assess the efficacy and safety of Gelesis100, a novel, nonsystemic, superabsorbent hydrogel to treat overweight or obesity.

methodsThe Gelesis Loss Of Weight (GLOW) study was a 24-week, multicenter, randomized, double-blind, placebo-controlled study in patients with BMI ≥  27 and ≤ 40 kg/m

resultsGelesis100 treatment caused greater weight loss over placebo (6.4% vs. 4.4%, P = 0.0007), achieving 2.1% superiority but not 3% super-superiority. Importantly, 59% of Gelesis100-treated patients achieved weight loss of ≥ 5%, and 27% achieved ≥ 10% versus 42% and 15% in the placebo group, respectively. Gelesis100-treated patients had twice the odds of achieving ≥ 5% and ≥ 10% weight loss versus placebo (adjusted OR: 2.0, P = 0.0008; OR: 2.1, P = 0.0107, respectively), with 5% responders having a mean weight loss of 10.2%. Patients with prediabetes or drug-naive type 2 diabetes had six times the odds of achieving ≥ 10% weight loss. Gelesis100 treatment had no apparent increased safety risks.

conclusionsGelesis100 is a promising new nonsystemic therapy for overweight and obesity with a highly desirable safety and tolerability profile.

Indexed as

Administration, OralDouble-Blind MethodFemaleHumansHydrogelsMaleMiddle AgedObesityWeight LossHydrogels

Identifiers

PMID30421844
PMCPMC6587502

What OpenQuestion 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 OpenQuestion graph.