Evidence mapPaperPMID 40730417Full record

Trial reportClinical obesity2026

Association of the Early Response to an Oral Shape-Shifting Superabsorbent Hydrogel Capsule With Weight Loss.

John M Jakicic, Donna H Ryan, Jamy D Ard, Patrick M O'Neil, Robert F Kushner, Holly R Wyatt, Harold E Bays, Frank L Greenway, Sharon Leonard, Yael Kenan and 2 more

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Clinical obesity, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Trial
  2. Trial
  3. 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

12 authors.

John M JakicicDivision of Physical Activity and Weight Management, Department of Internal Medicine, University of Kansas Medical Center, Kansas, USA.ORCID https://orcid.org/0000-0001-6800-9368
Donna H RyanPennington Biomedical Research Center, Louisiana State University, Louisiana, USA.
Jamy D ArdDepartment of Epidemiology and Prevention and Department of Medicine, Wake Forest University School of Medicine, North Carolina, USA.
Patrick M O'NeilWeight Management Center, Department of Psychiatry and Behavioral Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.ORCID https://orcid.org/0000-0002-0388-4046
Robert F KushnerDepartment of Medicine, Division of Endocrinology, Metabolism, and Molecular Medicine, Northwestern University Feinberg School of Medicine, Chicago, Illinois, USA.
Holly R WyattDepartment of Nutrition Sciences, The University of Alabama at Birmingham, Birmingham, Alabama, USA.
Harold E BaysLouisville Metabolic and Atherosclerosis Research Center, Louisville, Kentucky, USA.
Frank L GreenwayPennington Biomedical Research Center, Louisiana State University, Louisiana, USA.
Sharon LeonardDepartment of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.
Yael KenanEpitomee Medical Ltd, Israel.
Eti Ganon-ElazarEpitomee Medical Ltd, Israel.ORCID https://orcid.org/0009-0003-9722-9804
Thomas A WaddenDepartment of Psychiatry, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, USA.

Funding

Epitomee Medical Ltd
6 · The paper itself

Abstract

Early response (ER) to treatment is predictive of longer-term weight loss. In this post hoc analysis, ER to an oral shape-shifting superabsorbent hydrogel capsule (Epitomee) combined with a lifestyle intervention was compared to placebo combined with a lifestyle intervention. Participants (age = 48.5 ± 12.5 and 48.6 ± 12.4; BMI = 34.1 ± 3.3 and 33.7 ± 3.4, in the Epitomee and placebo groups, respectively) were randomised to Epitomee (N = 138) or placebo (N = 141) with lifestyle intervention. Analyses included body weight measurements taken at baseline, week 8, and week 24. Of the 279 participants enrolled in the study, 250 (90% of the ITT population) provided weight data, including 124 participants in the Epitomee group and 126 in the placebo group. Participants with missing weight data at week 24 were classified as non-responders. Early response (ER) was defined as a weight loss of ≥ 2% at week 8. Weight loss at week 24 was greater in ER to Epitomee compared to placebo (9.3% ± 6.0% vs. 6.9% ± 4.3%; p < 0.0001). The odds ratio for ER to achieve > 5% weight loss at week 24 was 4.10 (95% CI: 1.02, 16.46) for Epitomee and 2.38 (95% CI: 0.62, 9.21) for placebo. A greater proportion of ER to Epitomee, compared to placebo, achieved > 5% (76% vs. 62%; p = 0.0472), ≥ 7% (61% vs. 38%; p < 0.0045) and ≥ 10% (39% vs. 17%; p < 0.0025) weight loss at week 24. ER response to Epitomee was associated with greater weight loss at 24 weeks compared to placebo. Monitoring ER to Epitomee and titrating treatment based on ER may enhance weight loss.

Indexed as

HydrogelsObesityWeight LossAdultCapsulesDouble-Blind MethodFemaleHumansLife StyleMaleMiddle AgedTreatment OutcomeCapsulesHydrogelsearly responsemedical deviceobesityoverweightweight lossweight management

Identifiers

PMID40730417
PMCPMC12695463

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
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 Socratic graph.