"Gelesis100"

A Randomized, Double-Blind, Placebo-Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss. This study aims to assess the efficacy and safety of Gelesis100, a novel, nonsystemic, superabsorbent hydrogel to treat overweight or obesity. 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/m 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. Gelesis100 treatment caused greater weight loss over placebo (6.4% vs. 4.4%, P = 0.0007), achieving 2.1% superiority but not 3% super

SATISFY (geleSis100 Effects on AppeTIte Sensations, Feeding Behavior and Dietary energY) A recent clinical trial demonstrated the efficacy of Gelesis100 use for weight loss (Obes 2019;27:205-216). The present trial is designed to explore the mechanisms by which it may work, i.e. by suppressing hunger, altering food intake and/or altering the efficiency of energy extraction from food. Overweight the effects of Gelesis100, a FDA cleared superabsorbent hydrogel, on the mechanisms just noted. Gelesis100 is nonsystemic and works directly in the gastrointestinal tract. Gelesis100 is made from two natural ingredients, cellulose and citric acid, that form a three-dimensional matrix designed to occupy volume in the stomach and small intestine, to create a sensation of fullness. The capsules disintegrate

, diethylpropion, and Gelesis100 oral superabsorbent hydrogel. The guideline panel used the evidence-to-decision framework to develop recommendations for the pharmacological management of obesity and provided implementation considerations for clinical practice.ResultsThe guideline panel made 9 recommendations. The panel strongly recommended the use of pharmacotherapy in addition to lifestyle intervention ), for long-term management of overweight and obesity. The guideline panel suggested against the use of orlistat. The panel identified the use of Gelesis100 oral superabsorbent hydrogel as a knowledge gap.ConclusionsIn adults with overweight and obesity who have an inadequate response to lifestyle interventions alone, long-term pharmacological therapy is recommended, with multiple effective and safe

, diethylpropion, and Gelesis100 oral superabsorbent hydrogel. The guideline panel used the evidence-to-decision framework to develop recommendations for the pharmacological management of obesity and provided implementation considerations for clinical practice. The guideline panel made 9 recommendations. The panel strongly recommended the use of pharmacotherapy in addition to lifestyle intervention in adults management of overweight and obesity. The guideline panel suggested against the use of orlistat. The panel identified the use of Gelesis100 oral superabsorbent hydrogel as a knowledge gap. In adults with overweight and obesity who have an inadequate response to lifestyle interventions alone, long-term pharmacological therapy is recommended, with multiple effective and safe treatment options.

/topiramate, naltrexone/bupropion, gelesis100, setmelanotide, GLP-1 receptor antagonists (liraglutide, semaglutide, exenatide, lixisenatide, tirzepatide), metformin, pramlintide, topiramate, zonisamide, SGLT2 inhibitors (empagliflozin, dapagliflozin, canagliflozin, ertugliflozin).Comparator(s)/controlUsual care, including any lifestyle modification (reduced-calorie diet and increased physical activity

Study of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes Study of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record managers: refer to the Data WarningYou have reached the maximum number of saved studies (100).Please remove one or more studies before adding more. Study of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal

A Scintigraphic Study to Investigate the Effect of Gelesis100 on Gastric Emptying in Overweight and Obese Subjects A Scintigraphic Study to Investigate the Effect of Gelesis100 on Gastric Emptying in Overweight and Obese Subjects - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record Save this study WarningYou have reached the maximum number of saved studies (100).Please remove one or more studies before adding more. A Scintigraphic Study to Investigate the Effect of Gelesis100 on Gastric Emptying in Overweight and Obese Subjects The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has

Extension Study of Gelesis100 on Body Weight Extension Study of Gelesis100 on Body Weight - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record managers: refer to the Data Element Definitions if submitting registration or results information. Search for terms × * Find Studies * New adding more. Extension Study of Gelesis100 on Body Weight (GLOW-EX) The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT03021291

circumvent the challenge of unacceptable hunger levels which have derailed so many dietary interventions in the past.Gelesis200, when hydrated, is homogeneously mixed with the ingested food,increasing the volume and elasticity of the stomach and small intestine contents. This in turn may induce satiety,which reduces food intake. Previous studies with a similar hydrogel (Gelesis100) have shown increased satiety,reduced body weight(especially in prediabetics), and improved glycemic control. It is expected that Gelesis200 will have similar effects to Gelesis100. Furthermore, the physical properties of Gelesis200 (viscosity), which are similar to some dietary fibers, suggest that Gelesis200 will have a favorable impact on glycemic control.Study Design Go to Top of Page Study Description Study Design Arms

The Effect of Gelesis100 on the Pharmacokinetics of Metformin The Effect of Gelesis100 on the Pharmacokinetics of Metformin - Full Text View - ClinicalTrials.gov Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort. Hide glossary GlossaryStudy record managers: refer to the Data Element Definitions if submitting registration or results information. Search studies before adding more. The Effect of Gelesis100 on the Pharmacokinetics of Metformin The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT02524821

K, Matejkova E, Svacina S, Luzi L, Gnessi L, Navas-Carretero S, Alfredo Martinez J, Still CD, Sannino A, Saponaro C, Demitri C, Urban LE, Leider H, Chiquette E, Ron ES, Zohar Y, Heshmati HM. A Randomized, Double-Blind, Placebo-Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss. Obesity (Silver Spring). 2019 Feb;27(2):205-216. doi: 10.1002/oby.22347. Epub 2018 Nov 13

, or condom and spermicide; bilateral tubal ligation and vasectomy are acceptable contraceptive methods when combined with a single method above) 3. History of allergic reaction to CMC, citric acid, sodium stearyl fumarate, maltodextrin, gelatin, or titanium dioxide 4. Participation in a weight loss study within the past six (6) months 5. Administration of GSP2, GSP3, Gelesis100, or Gelesis200

of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer) 40. Any other clinically significant disease interfering with the assessments of Gelesis100, according to the Investigator (e.g., disease requiring corrective treatment, potentially leading to study discontinuation) 41. HbA1c > 8.5% (> 69 mmol/mol) 42. Positive test for drugs in the urine 43. Any relevant biochemical abnormality interfering with the assessments of Gelesis100, according to the Investigator 44. Antidiabetic medications within 1 month prior to Screening Visit (except stable dose of metformin, ≤ 1500 mg/day, for at least 1 month in subjects with type 2 diabetes) 45. Medications requiring mandatory administration with meal at lunch or dinner 46. Anticipated