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dc.creatorGreenway, F.L. (Frank L.)-
dc.creatorAronne, L.J. (Louis J.)-
dc.creatorRaben, A. (Anne)-
dc.creatorAstrup, A. (Arne)-
dc.creatorApovian, C.M. (Caroline M.)-
dc.creatorHill, J.O. (James O.)-
dc.creatorKaplan, L.M. (Lee M.)-
dc.creatorFujioka, K. (Ken)-
dc.creatorMatejkova, E. (Erika)-
dc.creatorSvacina, S. (Stephan)-
dc.creatorLuzi, L. (Livio)-
dc.creatorGnessi, L. (Lucio)-
dc.creatorNavas-Carretero, S. (Santiago)-
dc.creatorMartinez, J.A. (José Alfredo)-
dc.creatorStill, C.D. (Christopher D.)-
dc.creatorSannino, A. (Alessandro)-
dc.creatorSaponaro, C. (Cosimo)-
dc.creatorDemitri, C. (Christian)-
dc.creatorUrban, L.E. (Lorien E.)-
dc.creatorLeider, H. (Harry)-
dc.creatorChiquette, E. (Elaine)-
dc.creatorRon, E.S. (Eyal S.)-
dc.creatorZohar, Y. (Yishai)-
dc.creatorHeshmati, H.M. (Hassan M.)-
dc.date.accessioned2022-03-22T08:31:47Z-
dc.date.available2022-03-22T08:31:47Z-
dc.date.issued2019-
dc.identifier.citationGreenway, F.L. (Frank L.); Aronne, L.J. (Louis J.); Raben, A. (Anne); et al. "A randomized, double-blind, placebo-controlled study of gelesis100: A novel nonsystemic oral hydrogel for weight loss". Obesity. 27 (2), 2019, 205 - 216es
dc.identifier.issn1930-7381-
dc.identifier.other10.1002/oby.22347-
dc.identifier.urihttps://hdl.handle.net/10171/63284-
dc.description.abstractObjective: This study aims to assess the efficacy and safety of Gelesis100, a novel, nonsystemic, superabsorbent hydrogel to treat overweight or obesity. Methods: The 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/m2 and fasting plasma glucose ≥ 90 and ≤ 145 mg/dL. The co-primary end points were placebo-adjusted weight loss (superiority and 3% margin super-superiority) and at least 35% of patients in the Gelesis100 group achieving ≥ 5% weight loss. Results: Gelesis100 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. Conclusions: Gelesis100 is a promising new nonsystemic therapy for overweight and obesity with a highly desirable safety and tolerability profile.es_ES
dc.description.sponsorshipFLG has received funding/grant support/honorarium from A2 Milk, Novo Nordisk, Novartis, NuSirt, Zaluvida, Baronova, Basic Research, JennyCraig/Curves, General Nutrition Corporation, Microbiome Therapeutics, NeuroQuest, Plensat, and Zafgen. LJA has received funding/grant support/honorarium from Gelesis, Myos Corporation, Jamieson Wellness, Aspire Bariatrics, Inc., Eisai, Inc., Allurion, Novo Nordisk, Pfizer, Takeda Pharmaceuticals, Zafgen BMIQ, ERX, Astra Zeneca, Sanofi, Janssen, and United Heath Group, and he owns Gelesis stock options as a scientific advisor. AR has received funding/grant support/honorarium from Arla Foods, Nordic Sugar, Harboe Breweries, The EU FP7 and Horizon2020 programs, The Cambridge Weight Plan, Dairy Research Institute (United States), International Sweeteners Association, The Danish Meat and Research Institute, Gelesis, and The Danish Agriculture & Food Council. AA has received funding/grant support/honorarium for consultancy from Dutch Beer Institute, Feast Kitchen, Groupe Ethique et Sante, McCain Foods Limited, Nestle Research Center, Weight Watchers, Arla Foods, Danish Dairy Research Council, Gelesis, BioCare Copenhagen, Zaluvida, Basic Research, Beachbody, Danish Agriculture and Food Council, Novo Nordisk, Saniona, Scandinavian Airlines System, and Ikea, and he owns Gelesis stock options as a scientific advisor. CMA has received funding/grant support/honorarium from Gelesis, Novo Nordisk, Rhythm, Takeda, and Orexigen, and she owns Gelesis stock options as a scientific advisor. JOH has received funding/grant support/honorarium from Gelesis, Dupont, National Cattlemen’s Beef Association, Retrofit, and General Mills, and he owns Gelesis stock options as a scientific advisor. LMK has received honorarium for consultancy from AMAG, Ethicon, Gelesis, Novartis, Novo Nordisk, Rhythm, and Sanofi, and he owns Gelesis stock options as a scientific advisor. KF has received honorarium for consultancy from Gelesis. LG has received funding/grant support/honorarium from Novo Nordisk and L. Manetti-H. Roberts & C. AS, CS, CD, LEU, HL, EC, ESR, YZ, and HMH own Gelesis stock or stock options as employees. EM, SS, LL, SNC, JAM, and CDS declared no conflict of interest.es_ES
dc.language.isoenges_ES
dc.publisherWileyes_ES
dc.rightsinfo:eu-repo/semantics/openAccesses_ES
dc.subjectSuperabsorbent hydrogeles_ES
dc.subjectObesityes_ES
dc.subjectThe Gelesis Loss Of Weight (GLOW)es_ES
dc.subjectPlacebo-controlledes_ES
dc.titleA randomized, double-blind, placebo-controlled study of gelesis100: A novel nonsystemic oral hydrogel for weight losses_ES
dc.typeinfo:eu-repo/semantics/articlees_ES
dc.description.noteThis is an open access article under the terms of the Creative Commons Attribution-NonCommercial License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.es_ES
dadun.citation.endingPage216es_ES
dadun.citation.number2es_ES
dadun.citation.publicationNameObesityes_ES
dadun.citation.startingPage205es_ES
dadun.citation.volume27es_ES

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