Obesity PillarsPub Date : 2026-03-01Epub Date: 2025-11-20DOI: 10.1016/j.obpill.2025.100233
Sonya T. Gelfand , Meghan C. Tveit , James A. Simon
{"title":"Clinical review of how glucagon-like peptide-1 agonist obesity medications decrease sexual desire, and a biopsychosocial model for why we don’t ‘see’ it","authors":"Sonya T. Gelfand , Meghan C. Tveit , James A. Simon","doi":"10.1016/j.obpill.2025.100233","DOIUrl":"10.1016/j.obpill.2025.100233","url":null,"abstract":"<div><h3>Background</h3><div>While prevailing assumptions suggest that improved body image and erectile function, even in people with diabetes, associated with glucagon-like peptide-1 (GLP-1) agonist medications would correlate with heightened sexual function, there is limited literature on the effects of GLP-1 agonists on hedonistic pleasures such as sexual activity. In this paper, we aim to elucidate the potential implications of GLP-1 agonists on sexual desire by proposing a serotonergic mechanism by which GLP-1 agonists theoretically decrease sexual desire, and a biopsychosocial perspective on why this effect may be camouflaged by competing influences.</div></div><div><h3>Methods</h3><div>This was a narrative review analysis with target literature search. A PubMed search was conducted to identify systematic reviews or meta-analyses investigating the effects of GLP-1 agonists on physiological and lifestyle factors. We used the same methodology to investigate the connection between GLP-1 agonism and the brain’s reward pathways to elucidate whether a connection exists between GLP-1 agonism and sexual desire.</div></div><div><h3>Results</h3><div>We established a theoretical model for how GLP-1 agonist modulation via increased serotonergic activity at the 5-HT2C receptor may result in diminished sexual desire. We then applied a biopsychosocial framework to highlight why this effect may be overlooked by GLP-1-treated patients and clinicians. Although the serotonergic pathway may create a physiological decrease in sexual desire for patients taking GLP-1 agonists, we postulate that this diminishing influence of GLP-1 agonism is both compounded by factors such as undesirable side effects and increased SHBG and offset by the enhancing influences on sexual desire such as increased total testosterone, and improved vascular reactivity and mood.</div></div><div><h3>Conclusion</h3><div>Failing to systematically measure and report on sexual desire as a potential adverse outcome of GLP-1 agonist use overlooks an essential aspect of patient well-being. Future research should prioritize longitudinal studies to assess changes in sexual desire among individuals prescribed GLP-1 agonists.</div></div>","PeriodicalId":100977,"journal":{"name":"Obesity Pillars","volume":"17 ","pages":"Article 100233"},"PeriodicalIF":0.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145625393","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Obesity PillarsPub Date : 2026-03-01Epub Date: 2025-11-11DOI: 10.1016/j.obpill.2025.100228
J.L. Sievenpiper , J. Ard , M. Blüher , W. Chen , J.B. Dixon , A. Fitch , L. Gigliotti , K. Khunti , A. Lecube , M.E.J. Lean , B. Mittendorfer , A.F.H. Pfeiffer , D.H. Ryan , T. Vilsbøll , L.F. Van Gaal
{"title":"Nutritional and lifestyle supportive care recommendations for management of obesity with GLP-1 - based therapies: An expert consensus statement using a modified Delphi approach","authors":"J.L. Sievenpiper , J. Ard , M. Blüher , W. Chen , J.B. Dixon , A. Fitch , L. Gigliotti , K. Khunti , A. Lecube , M.E.J. Lean , B. Mittendorfer , A.F.H. Pfeiffer , D.H. Ryan , T. Vilsbøll , L.F. Van Gaal","doi":"10.1016/j.obpill.2025.100228","DOIUrl":"10.1016/j.obpill.2025.100228","url":null,"abstract":"<div><h3>Background</h3><div>Liraglutide, semaglutide and tirzepatide have transformed the management of obesity. However, dose-related gastrointestinal effects, obesity-associated nutritional insufficiencies, and poor long-term adherence may limit their long-term health benefits. Despite a recent joint advisory summarizing nutritional and lifestyle supportive care priorities with these therapies, there is still a significant lack of direct evidence to guide clinical practice, making consensus-based recommendations necessary.</div></div><div><h3>Methods</h3><div>The consensus statement development was based on an initial scoping review that included searching PubMed, Embase, Web of Science, Cochrane, and Medline for relevant scientific publications from January 1, 2021 through June 30, 2025. An international multidisciplinary panel consisting of physicians, clinical researchers, and dietitians employed a modified Delphi process to develop clinical practice recommendations for nutritional and lifestyle strategies that may assist people on glucagon-like peptide 1 based therapies (GBT) in optimizing treatment experience and improving health outcomes.</div></div><div><h3>Results</h3><div>A total of 52 consensus statements were developed, outlining key considerations for the practical management of obesity and associated complications with GBTs, with a focus on nutritional factors in relation to obesity, body composition, physical activity, and the management of common gastrointestinal symptoms such as nausea, vomiting, diarrhoea, and constipation. The consensus statements include practical strategies supporting the weight loss journey, from before starting a GBT, during the weight loss and weight maintenance phases, and in case of GBT discontinuation. The statements were primarily derived from indirect evidence, including from existing evidence and established guidelines for nutrition therapy in bariatric medicine and relevant clinical experience.</div></div><div><h3>Conclusions</h3><div>These expert consensus recommendations offer healthcare professionals practical guidance on nutritional and lifestyle interventions for patients undergoing GBT-related weight management, complementing current recommendations. Further direct evidence is urgently required to inform and enhance optimal clinical care.</div></div>","PeriodicalId":100977,"journal":{"name":"Obesity Pillars","volume":"17 ","pages":"Article 100228"},"PeriodicalIF":0.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145799725","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Obesity PillarsPub Date : 2026-03-01Epub Date: 2025-11-27DOI: 10.1016/j.obpill.2025.100238
Alvin Mondoh , Francisca Contreras , Hilary Craig , Michael Crotty , Carel W. le Roux
{"title":"Logistics, effectiveness, safety, and accessibility: Factors determining obesity medication patient preferences from a photovoice analysis","authors":"Alvin Mondoh , Francisca Contreras , Hilary Craig , Michael Crotty , Carel W. le Roux","doi":"10.1016/j.obpill.2025.100238","DOIUrl":"10.1016/j.obpill.2025.100238","url":null,"abstract":"<div><h3>Background</h3><div>Obesity is a chronic, relapsing, and multifactorial disease that necessitates sustained, patient-centred management. Although pharmacotherapy is now an integral component of obesity care, there is limited evidence regarding the factors influencing patients’ choices among specific medications. As part of the Innovative Medicines Initiative 2 (IMI2) programme. Stratification of Obesity Phenotypes to Optimize Future Obesity Therapy (SOPHIA) and the second phase of a three-part qualitative doctoral programme, the present study is built upon previous interview findings that examined how patients conceptualize and interpret the factors shaping their pharmacotherapy preferences.</div></div><div><h3>Methods</h3><div>A qualitative Photovoice methodology was employed with treatment naive adults attending a specialist weight management clinic. Participants captured photographs reflecting factors shaping their medication choices and they also engaged in facilitated reflective interviews. Data was analysed using the MAXQDA 2024 software and the Braun and Clarke's framework for reflexive thematic analysis.</div></div><div><h3>Results</h3><div>The photovoice analysis revealed 4 themes around patient preferences for obesity medications including a) Logistics around Lifestyle, b) Effectiveness, c) Safety, risk and tolerability and d) Accessibility.</div></div><div><h3>Conclusion</h3><div>Patient preferences for obesity pharmacotherapy arise from the interaction of efficacy expectations with logistical challenged, while concerns regarding safety and accessibility also contribute to decision making. Clinicians should include explanations how the medications can fit into the lifestyle of patients, while also addressing structural barriers that may affect access to treatment, but ultimately allowing patients to understand the balance between efficacy and safety will allow optimal shared decision-making to support sustainable pharmacotherapy pathways.</div></div>","PeriodicalId":100977,"journal":{"name":"Obesity Pillars","volume":"17 ","pages":"Article 100238"},"PeriodicalIF":0.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145694478","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Obesity PillarsPub Date : 2025-12-01Epub Date: 2025-08-29DOI: 10.1016/j.obpill.2025.100206
Nora Struckmeyer , Torben Biester , Chantal Weiner , Evelin Sadeghian , Cathrin Guntermann , Laura Galuschka , Kisa von Stuelpnagel , Jantje Weiskorn , Kerstin Kapitzke , Karin Lange , Thomas Danne , Rebecca Toenne , Felix Reschke
{"title":"Evaluating the long-term effectiveness of a structured telehealth obesity program in children and adolescents: A retrospective matched-control study","authors":"Nora Struckmeyer , Torben Biester , Chantal Weiner , Evelin Sadeghian , Cathrin Guntermann , Laura Galuschka , Kisa von Stuelpnagel , Jantje Weiskorn , Kerstin Kapitzke , Karin Lange , Thomas Danne , Rebecca Toenne , Felix Reschke","doi":"10.1016/j.obpill.2025.100206","DOIUrl":"10.1016/j.obpill.2025.100206","url":null,"abstract":"<div><h3>Background</h3><div>Childhood obesity is a growing global health crisis, driven by poor diet, reduced physical activity, and psychosocial distress. The COVID-19 pandemic amplified these factors, contributing to rising BMI and impaired health-related quality of life (HrQoL). Telehealth offers a promising, scalable modality to deliver multimodal obesity care. This study evaluated the long-term effectiveness of a structured pediatric telehealth intervention compared to historical in-person treatment.</div></div><div><h3>Methods</h3><div>This retrospective cohort study analyzed data from 237 children and adolescents with obesity treated at a single academic center. Between 2020 and 2022, 117 participants received a 12-month structured lifestyle intervention via telehealth. A historical cohort (n = 120; 2017–2019) received the same intervention in person. Clinical outcomes were assessed at baseline and after 12 months; the telehealth group was additionally followed up at 24 and 36 months. Primary outcome was change in BMI standard deviation score (BMI SDS). Secondary outcomes included physical fitness (6-min walk test), insulin resistance (HOMA index), lipid profile, dietary behavior (K-FFL), eating regulation (K-FEV), and HrQoL (KINDL-R).</div></div><div><h3>Results</h3><div>Both groups achieved significant reductions in BMI SDS after 12 months, with sustained improvements in the telehealth group through 36 months (Δ = −0.18; p < 0.05). Physical performance and HOMA index improved in both cohorts. Telehealth participants showed greater improvements in healthy dietary behavior, cognitive appetite regulation, and Health-related quality of life HrQoL, especially in emotional and family domains. No adverse events occurred; adherence exceeded 85 %.</div></div><div><h3>Conclusion</h3><div>A structured telehealth lifestyle intervention is safe, effective, and sustainable for pediatric obesity management. These findings support telehealth as a clinically viable and sustainable model for pediatric obesity care, recognizing that both weight reduction and weight stabilization may contribute to improved long-term outcomes.</div></div>","PeriodicalId":100977,"journal":{"name":"Obesity Pillars","volume":"16 ","pages":"Article 100206"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144988586","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Obesity PillarsPub Date : 2025-12-01Epub Date: 2025-07-26DOI: 10.1016/j.obpill.2025.100199
Kevin L. Roddy, Matthew R. Greenwald, Nicholas Hollman, Madisen F. Dorand, Jesse R. Richards
{"title":"Obesity treatment as a bridge to solid organ transplantation: A comparison of bariatric surgery to medical therapy","authors":"Kevin L. Roddy, Matthew R. Greenwald, Nicholas Hollman, Madisen F. Dorand, Jesse R. Richards","doi":"10.1016/j.obpill.2025.100199","DOIUrl":"10.1016/j.obpill.2025.100199","url":null,"abstract":"<div><h3>Background</h3><div>Organ transplant is a rapidly growing area of medicine, with over 42,800 organ transplants occurring in 2022.[1] Obesity complicates the transplant surgery process; historically, the only available treatment for patients with both severe obesity and end-organ damage requiring transplant was bariatric surgery. Glucagon-like peptide-1 (GLP-1) and dual GLP-1/glucose-dependent insulinotropic polypeptide (GIP) agonists (such as semaglutide and tirzepatide, respectively) may offer a non-surgical alternative to weight management prior to transplant surgery.</div></div><div><h3>Methods</h3><div>This descriptive case series utilized retrospective chart review to compare peri-transplant weight loss in individuals treated with bariatric surgery alone, GLP-1 or GLP-1/GIP medication without surgical intervention, and GLP-1 or GLP-1/GIP medication with surgical intervention. Nineteen (N = 19) patients pursuing kidney transplant met inclusion criteria. Primary outcomes of interest in each group were median weight loss, total weight loss percent, and portion of individuals who met the BMI cut-off for transplantation following the intervention.</div></div><div><h3>Results</h3><div>Individuals treated with tirzepatide (n = 9) demonstrated 8 % less weight loss than the surgical-intervention group, and 77.8 % (n = 7) met BMI cutoff for transplant after treatment. Among patients treated with semaglutide (n = 4), 50 % (n = 2) met BMI cutoff for transplant. In the bariatric-surgery only group, 66.7 % (n = 2) met the BMI cutoff for transplant. Among those who received both bariatric surgery and GLP-1 medication (n = 3), all met the BMI cutoff for transplant.</div></div><div><h3>Conclusions</h3><div>This descriptive case series demonstrates that the current generation of weight loss medications produce a degree of weight loss comparable to bariatric surgery; this is particularly relevant to individuals with obesity who are pursuing organ transplant. Conclusions are limited due to the small, retrospective, and observational nature of this study; however, the results support the hypothesis that medications could revolutionize the organ transplant process by providing a reasonable non-surgical weight loss option for individuals with obesity. Further study with a larger, prospective randomized trial is needed to fully evaluate the viability of utilizing anti-obesity medications for this unique clinical indication.</div></div>","PeriodicalId":100977,"journal":{"name":"Obesity Pillars","volume":"16 ","pages":"Article 100199"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144902395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Exploring the effects of high protein versus high fat snacks on satiety, gut hormones and insulin secretion in women with overweight and obesity: A randomized clinical trial","authors":"Nahla Al-Bayyari , Maysoon Alhameedy , Razan Omoush , Hadeel Ghazzawi","doi":"10.1016/j.obpill.2025.100212","DOIUrl":"10.1016/j.obpill.2025.100212","url":null,"abstract":"<div><h3>Background</h3><div>Nuts generally blunt the postprandial increases in glucose levels and increase satiety, while yogurt studies yield inconclusive results regarding post-meal hunger. This study investigated the effects of high-protein, and high-fat snacks, specifically Greek yogurt, and peanuts, on satiety, gut hormones, and insulin secretion in women with overweight and obesity. The hypothesis posited that peanuts would exhibit a more beneficial impact on satiety, gut hormones, and insulin levels compared to Greek yogurt.</div></div><div><h3>Methods</h3><div>The two-arm parallel randomized trial involved fifty participants aged 30–40 years with a BMI between 25 and 35 kg/m<sup>2</sup>, randomly divided into peanut (n = 25) and Greek yogurt (n = 25) groups. After three days of adhering to 1200 Kcal diet, appetite sensations were gauged using a visual analog scale (VAS) upon arrival, and at 30- and 60-min post-snack. Pre- and post-snacking, plasma levels of cholecystokinin (CCK), Peptide Tyrosine-Tyrosine (PYY), Glucagon Like Peptide-1 (GLP-1), Ghrelin (GHRL), and insulin were analyzed.</div></div><div><h3>Results</h3><div>Revealed that Greek yogurt induced a statistically significant increase in satiety 30 min after consumption and markedly elevated postprandial insulin levels compared to peanuts. Moreover, notable intergroup differences in postprandial insulin concentrations were observed in the Greek yogurt group. The peanut group had no significant alterations in PYY, GLP-1, CCK or GHRL levels. Pre-snacking, GHRL levels exhibited a positive association with abdominal circumference, weight, and fat mass, while CCK levels displayed a negative association with abdominal circumference, weight, and fat mass.</div></div><div><h3>Conclusion</h3><div>Greek yogurt may enhance satiety and thus has the potential to positively influence body weight in individuals with overweight and/or obesity. Further research is required to elucidate appetite control mechanisms.</div></div><div><h3>Trial registration</h3><div>The study was registered on <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (No. NCT 04518930).</div></div>","PeriodicalId":100977,"journal":{"name":"Obesity Pillars","volume":"16 ","pages":"Article 100212"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145227026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Obesity PillarsPub Date : 2025-12-01Epub Date: 2025-09-08DOI: 10.1016/j.obpill.2025.100209
Brittany V.B. Johnson, Mary Milstead, Rachel Kreider, Rachel Jones
{"title":"Dietary supplement considerations during glucagon-like Peptide-1 receptor agonist treatment: A narrative review","authors":"Brittany V.B. Johnson, Mary Milstead, Rachel Kreider, Rachel Jones","doi":"10.1016/j.obpill.2025.100209","DOIUrl":"10.1016/j.obpill.2025.100209","url":null,"abstract":"<div><h3>Background</h3><div>Recent advancements with Glucagon-like Peptide-1 Receptor Agonists (GLP-1RA) result in approximately 15 % or more weight reduction. Scientific research addressing specific nutritional concerns with GLP-1RA are still emerging. While some guidelines currently exist for nutritional considerations, they are largely focused on side effect management and providing basic dietary guidance during GLP-1RA.</div></div><div><h3>Methods</h3><div>This narrative review aims to provide practical evidence-based considerations for dietary supplementation to help optimize health outcomes while using GLP-1RA. We reviewed available literature of dietary supplementation interventions among individuals with obesity, weight loss clinical trials, and adiposity-related complications to help guide clinicians on potentially advantageous supplementation.</div></div><div><h3>Results</h3><div>Robust data from meta-analyses provides justification for a variety of dietary supplements that can support the unintended consequences of GLP-1RA treatments. Multivitamins are recommended to address micronutrient insufficiencies as determined by individual deficiencies and suboptimal intake. Protein supplements can help individuals meet daily protein intake recommendations of 1.2–2.0 g/kg/d. When combined with resistance training, whey protein can help preserve lean body mass during weight loss, with additional strength benefits from creatine monohydrate and β-Hydroxy β-Methylbutyrate supplementation. Antioxidants and anti-inflammatory nutrients can mitigate oxidative stress and inflammation. Fiber and probiotics can improve bowel regularity and mitigate side effects.</div></div><div><h3>Conclusion</h3><div>Healthcare providers play an active role in supporting their patients with comprehensive obesity treatment. Guidance should focus on improving their long-term health and potentially mitigating unintended consequences. Optimizing nutrient intakes with therapeutic doses of dietary supplements may enhance outcomes when used alongside GLP-1RA, such as increasing nutrient status, retaining lean mass, reducing oxidative stress and inflammation, and improving gastrointestinal health.</div></div>","PeriodicalId":100977,"journal":{"name":"Obesity Pillars","volume":"16 ","pages":"Article 100209"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145048594","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Obesity PillarsPub Date : 2025-12-01Epub Date: 2025-10-08DOI: 10.1016/j.obpill.2025.100215
{"title":"Response to Letter to the Editor","authors":"","doi":"10.1016/j.obpill.2025.100215","DOIUrl":"10.1016/j.obpill.2025.100215","url":null,"abstract":"","PeriodicalId":100977,"journal":{"name":"Obesity Pillars","volume":"16 ","pages":"Article 100215"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145265494","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Obesity PillarsPub Date : 2025-12-01Epub Date: 2025-10-20DOI: 10.1016/j.obpill.2025.100216
Moshe Kamar , Donna H. Ryan , Sharon Leonard , Holly R. Wyatt , Yael Kenan , Liora Cohen Asaraf , Eti Ganon-Elazar , Jamy D. Ard
{"title":"The safety and efficacy of extended use of an oral shape-shifting superabsorbent hydrogel capsule for weight loss: The ELECT extension study","authors":"Moshe Kamar , Donna H. Ryan , Sharon Leonard , Holly R. Wyatt , Yael Kenan , Liora Cohen Asaraf , Eti Ganon-Elazar , Jamy D. Ard","doi":"10.1016/j.obpill.2025.100216","DOIUrl":"10.1016/j.obpill.2025.100216","url":null,"abstract":"<div><h3>Background</h3><div>Long-term weight-loss maintenance remains challenging despite of the numerous available treatments. The previously published pivotal randomized RESET study demonstrated a mean weight reduction from baseline of 6.6 % with Epitomee and a mean weight reduction of 4.6 % with placebo (p < 0.001). In this study we investigated the efficacy and safety of the extended use of Epitomee, an FDA cleared, non-pharmacological treatment for weight management.</div></div><div><h3>Methods</h3><div>In this open label extension study, a subset of participants in the RESET study who lost ≥3 % of initial body weight during a 24-week treatment with Epitomee capsule or placebo, as an adjunct to lifestyle counseling, were eligible for a 24-week open-label extension study (ELECT).</div></div><div><h3>Results</h3><div>Continuous treatment with Epitomee and lifestyle counseling for 48 weeks was associated with sustained reduction in body weight of 11.2 ± 8.4 % (p < 0.001) and sustained prior improvements in cardiometabolic risk factors and quality of life (QOL). Taking the Epitomee capsule for 24 weeks, after previous weight loss with the placebo treatment, was associated with an additional 1.5 ± 4.2 % weight loss, yielding a total 7.5 ± 5.5 % reduction at 48 weeks and additional improvements in QOL. Capsule adherence exceeded 94 %. Extended use of Epitomee had a favorable safety profile, with no serious adverse device-related events and no discontinuation due to adverse events.</div></div><div><h3>Conclusions</h3><div>In this open-label study, extended use of Epitomee, combined with lifestyle counseling, was associated with maintenance of prior weight loss and favorable safety profile (NCT04994769).</div></div>","PeriodicalId":100977,"journal":{"name":"Obesity Pillars","volume":"16 ","pages":"Article 100216"},"PeriodicalIF":0.0,"publicationDate":"2025-12-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145424615","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}