Effect of Gelesis200 on Body Weight in Overweight and Obese Subjects w/o Type 2 Diabetes

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Overweight, Diabetes, PreDiabetes, Obesity

In brief

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of Gelesis200 on Body Weight in Overweight and Obese Subjects without or with Type 2 Diabetes

Key facts

Study ID: NCT03058029
Run by: Gelesis, Inc.
People needed: 300
Starts: 2017-02-22
Expected to finish: 2021-01-15
Last updated by the study team: 2020-07-21

Who can join

Age: 22 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Male or female
Age ≥22 years and ≤65 years
Ambulatory
BMI ≥27 kg/M2 and ≤40 kg/M2
Non-diabetic subjects, including:
Normoglycemic subjects with FPG <100 mg/dL [<5.6 mmol/L] at both Screening Visits with HbA1c <5.7% (<39 mmol/mol), or
Prediabetic subjects with FPG ≥100 mg/dL and <126 mg/dL (≥5.6 mmol/L and ≤7.0 mmol/L) at both Screening Visits with HbA1c ≤6.4% (≤46 mmol/mol) [if only one (1) value is within this range, the other value should not be ≥126 mg/dL (≥7.0 mmol/L) and HbA1c should be ≥5.7% (≥39 mmol/mol) and ≤6.4% (≤46 mmol/mol)]; or Diabetic subjects, including:
Untreated subjects with FPG ≤200 mg/dL (≤11.2 mmol/L) at both Screening Visits and either FPG ≥126 mg/dL (≥7.0 mmol/L) at both Screening Visits or FPG <126 mg/dL (<7.0 mmol/L) at one (1) or both Screening Visits with HbA1c ≥6.5% (≥48 mmol/mol), or
Drug-treated subjects with metformin and/or DPP-4 inhibitors with FPG ≥70 mg/dL and ≤270 mg/dL (≥3.9 mmol/L and ≤15.1 mmol/L) at both Screening Visits
Ability to follow verbal and written instructions
Consent obtained via signed ICF

You may not qualify if…

Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential)
Absence of medically approved contraception in females of childbearing potential (e.g., hysterectomy, oral contraceptive medications, intrauterine device combined with a barrier method, two (2) combined barrier methods such as diaphragm and condom or spermicide, or condom and spermicide; bilateral tubal ligation and vasectomy are acceptable contraceptive methods when combined with a single method above)
History of allergic reaction to CMC, citric acid, sodium stearyl fumarate, maltodextrin, gelatin, or titanium dioxide
Participation in a weight loss study within the past six (6) months
Administration of GSP2, GSP3, Gelesis100, or Gelesis200 in a previous study
Administration of investigational products within one (1) month prior to Screening Visit 1
Blood transfusion within three (3) months prior to Screening Visit 1
Smoking cessation within six (6) months prior to Screening Visit 1 or considering smoking cessation during the study
Anticipated surgical intervention during the study period
Known Type 1 Diabetes
History of eating disorders including binge eating (except mild binge eating) or emesis ≥2/week from any cause within six (6) months prior to Screening Visit 1
Weight change ≥3% within three (3) months prior to and during the Screening period
Supine SBP >160 mm Hg and/or supine DBP >95 mm Hg
Angina, coronary bypass, or myocardial infarction within six (6) months prior to Screening Visit 1
History of swallowing disorders within six (6) months prior to Screening Visit 1
Esophageal anatomic abnormalities (e.g., webs, diverticuli, rings)
History of gastric or duodenal ulcer within six (6) months prior to Screening Visit 1
History of gastroparesis (e.g., chronic nausea, vomiting ≥2 occurrences per week, heartburn, etc.) within six (6) months prior to Screening Visit 1
History of gastric bypass or any other gastric surgery
History of inflammatory bowel diseases
History of intestinal stricture (e.g., Crohn's disease)
History of intestinal obstruction or high risk of intestinal obstruction, including suspected small bowel adhesions
History of pancreatitis within six (6) months prior to Screening Visit 1
History of malabsorption within six (6) months prior to Screening Visit 1
Laxative users, except those on stable doses within one (1) month prior to Screening Visit 1

Where it is running

Central Alabama Research — Birmingham, Alabama, United States
Meridien Research, Inc - Bradenton — Bradenton, Florida, United States
Baptist Diabetes Associates, P.A. — Miami, Florida, United States
Metabolic Research Institute, Inc. — West Palm Beach, Florida, United States
The Center for Pharmaceutical Research — Kansas City, Kansas, United States
Clinical Research Center of Nevada — Las Vegas, Nevada, United States
Radiant Research — Cincinnati, Ohio, United States
Mountain View Clinical Research - Greer — Greer, South Carolina, United States
Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville — Knoxville, Tennessee, United States
SAMCRC — San Antonio, Texas, United States
Tarheel Clinical Research, LLC — Sugar Land, Texas, United States
Rainier Clinical Research Center — Renton, Washington, United States
University of Ottawa - Institut de Recherche de l'Hospital d'Ottawa (IRHO) (Ottawa Hospital Research Institute (OHRI)) — Ottawa, Ontario, Canada
Université Laval — Québec, Quebec, Canada
Health&Care, s.r.o — Prague, Czechia
University of Copenhagen - Department of Nutrition, Exercise and Sports — Frederiksberg, Denmark
Qualiclinic Kft — Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont — Debrecen, Hungary
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz — Gyula, Hungary
IRCCS Policlinico San Donato — San Donato Milanese, Italy
NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny — Bialystok, Poland
NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek — Lodz, Poland
MEDICOME Sp. z o.o. — Oświęcim, Poland
Centrum Zdrowia Metabolicznego Pawel Bogdanski — Poznan, Poland
Centrum Badawcze Wspolczesnej Terapii — Warsaw, Poland

Full record on ClinicalTrials.gov

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