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

Authors

• John M. Jakicic, University of Kansas Medical Center, Kansas City, KS
• Donna H. Ryan, Pennington Biomedical Research Center, Baton Rouge, LA
• Jamy D. Ard, Wake Forest University School of Medicine, Winston-Salem, NC
• Patrick M. O'Neil, Medical University of South Carolina, Charleston, SC
• Robert F. Kushner, Northwestern University Feinberg School of Medicine, Chicago, IL
• Holly R. Wyatt, The University of Alabama at Birmingham, Birmingham, AL
• Harold E. Bays, Louisville Metabolic and Atherosclerosis Research Center, Louisville, KY
• Frank L. Greenway, Pennington Biomedical Research Center, Baton Rouge, LA
• Sharon Leonard, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA
• Yael Kenan, Epitomee Medical Ltd, Israel
• Eti Ganon-Elazar, Epitomee Medical Ltd, Israel
• Thomas A. Wadden, University of Pennsylvania Perelman School of Medicine, Philadelphia, PA

Document Type

Article

Publication Date

7-29-2025

Publication Title

Clinical Obesity

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.

First Page

1

Last Page

9

DOI

10.1111/cob.70037

Creative Commons License

This work is licensed under a Creative Commons Attribution-NonCommercial-No Derivative Works 4.0 International License.

Recommended Citation

Jakicic, John M.; Ryan, Donna H.; Ard, Jamy D.; O'Neil, Patrick M.; Kushner, Robert F.; Wyatt, Holly R.; Bays, Harold E.; Greenway, Frank L.; Leonard, Sharon; Kenan, Yael; Ganon-Elazar, Eti; and Wadden, Thomas A., "Association of the Early Response to an Oral Shape-Shifting Superabsorbent Hydrogel Capsule With Weight Loss" (2025). LSU-LCMC Cancer Center Faculty Publications. 207.
https://digitalscholar.lsuhsc.edu/llcc_facpubs/207
10.1111/cob.70037