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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 Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02307279
Recruitment Status : Completed
First Posted : December 4, 2014
Results First Posted : August 30, 2022
Last Update Posted : August 30, 2022
Sponsor:
Information provided by (Responsible Party):
Gelesis, Inc.

Brief Summary:
This study will asses the decrease in body weight after repeated administration of Gelesis100 in overweight and obese subjects with and without Type 2 Diabetes.

Condition or disease Intervention/treatment Phase
Overweight Obesity Device: Gelesis100 Device: placebo Not Applicable

Detailed Description:
To asses the decrease in body weight after repeated administration of Gelesis100 in overweight and obese subjects with and without Type 2 Diabetes.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 436 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes
Actual Study Start Date : November 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Body Weight

Arm Intervention/treatment
Experimental: Gelesis100
Gelesis100 twice daily
Device: Gelesis100
Placebo Comparator: Placebo
Matching placebo twice daily
Device: placebo



Primary Outcome Measures :
  1. Co-Primary Outcome: Percent Change in Body Weight [ Time Frame: Baseline to Day 171 ]
    Percent change in body weight from Baseline to Day 171 is presented.

  2. Co-Primary Outcome: Percentage of Subjects Who Achieve Body Weight Loss ≥ 5% [ Time Frame: Baseline to Day 171 ]
    Percentage of participants who achieve a body weight loss ≥ 5% from Baseline to Day 171 is presented.


Secondary Outcome Measures :
  1. Percent Body Weight Change in Subjects With Impaired Plasma Glucose Status at Baseline [ Time Frame: Baseline to Day 171 ]
    Impaired plasma glucose status is defined as Fasting Plasma Glucose (FPG) ≥100mg/dL and <126mg/dL at baseline measurement.

  2. Change in Plasma Glucose Status (Normal, Impaired, Diabetic) in Subjects With Impaired Plasma Glucose Status at Baseline. [ Time Frame: Baseline to Day 171 ]
    Normal plasma glucose status is defined FPG ≤ 100mg/dL. Impaired plasma glucose status is defined as FPG ≥100mg/dL and <126mg/dL. Diabetic plasma glucose status was defined as FPG >126mg/dL.

  3. Percent Change in Plasma Glucose [ Time Frame: Baseline to Day 171 ]
    Percent change in Plasma Glucose in subjects with impaired glucose and T2D at baseline. Impaired plasma glucose is defined as FPG≥100mg/dL and FPG<126mg/dL.

  4. Change in Body Mass Index (BMI) [ Time Frame: Baseline to Day 171 ]
    The BMI was calculated using height (in cm) and weight (in kg) according to the following formula: BMI (kg/m2((superscript 1)) = Weight (kg)/[Height (cm)/100]2(superscript2).

  5. Change in Hemoglobin HbA1c in Subjects With Type 2 Diabetes at Baseline [ Time Frame: Baseline to Day 171 ]
    To assess the decrease in HbA1c after repeated administration of Gelesis 100 over a period of 168 days in overweight and obese people with type 2 diabetes, The glycosylated hemoglobin was measured in mmol/mol.


Other Outcome Measures:
  1. Assess Safety and Tolerability of Administration of Gelesis100 [ Time Frame: Baseline to Day 197 ]
    Adverse Events (AEs), Physical Examinations, Vital Signs, Laboratory Tests



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 22 to 65 years of age, inclusive
  • Signed Informed Consent Form
  • BMI 27 to 40, inclusive (BMI of <30 should have at least one comorbidity)
  • Fasting plasma glucose 90mg/dL to 145 mg/dL, inclusive; non-diabetic normoglycemic (fasting glucose 90 mg/dL to 100 mg/dL, inclusive); non-diabetic impaired fasting glucose 100mg/dL to 126 mg/dL; and diabetic: untreated (126 mg/dL to 145 mg/dL, inclusive) and metformin-treated (metformin dose 1500mg/DL and less, fasting glucose less than 145 mg/dL, inclusive)

Exclusion Criteria:

  • Pregnancy or lactation
  • Absence of medically approved contraceptive methods in females of childbearing potential
  • History of allergic reaction to modified cellulose, citric acid, sodium stearyl fumarate, raw cane sugar, gelatin, and titanium oxide
  • Administration of investigational products within 1 month prior to Screening Visit
  • Subjects who stopped smoking within 6 months prior to Screening Visit or considering smoking cessation during the study
  • Subjects anticipating surgical intervention during the study
  • Known Type 1 diabetes
  • History of eating disorders
  • Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
  • History of: swallowing disorders, esophogeal anatomic abnormalities, gastroesophageal reflux disease, gastric or duodenal ulcer, gastroparesis (chronic nausea, vomiting, heartburn...), gastric bypass or other gastric surgery, intestinal obstruction or at high risk of including suspected small bowel adhesion, pancreatitis, malabsorption, history of bowel resection (except if related to appendectomy), history of abdominal radiation treatment
  • Laxative users
  • History of: HIV, hepatitis B or C; cancer within the past 5 years
  • Abnormal serum thyroid-stimulating hormone (TSH)
  • Positive urine drug test
  • Anti-obesity medication within 1 month prior to Screening Visit (except stable doses of metformin, no more than 1500 mg/day, for at leaset 1 month in subjects with type 2 diabetes)
  • Systemic corticosteroids within 1 month prior to Screening Visit
  • Thyroid hormones or preparations within 1 month prior to Screening Visit
  • Estrogen within 1 month prior to Screening Visit
  • Any other medication known to cause weight loss or weight gain within 1 month prior to Screening Visit
  • TSH suppression therapy for thyroid cancer
  • medications requiring mandatory administration with meal (lunch or dinner), except metformin
  • Other medication or product used for chronic diseases if their impaired gastrointestinal absorption can cause safety issues
  • Change in medications treating hypertension and/or dyslipidemia within 1 month prior to Screening Visit (including change in dose)
  • Anticipated requirement for use of prohibited concomitant medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02307279


Locations
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United States, California
Investigative Site
Anaheim, California, United States, 92801
Investigative Site
San Diego, California, United States, 92103
Investigative Site
Tustin, California, United States, 92780
Investigative Site
Walnut Creek, California, United States, 94598
Investigative Site
West Hills, California, United States, 91307
United States, Colorado
Investigative Site
Aurora, Colorado, United States, 80045
United States, Florida
Investigative Site
Jacksonville, Florida, United States, 32205
Investigative Site
Miami, Florida, United States, 33143
United States, Idaho
Investigative Site
Boise, Idaho, United States, 83642
United States, Illinois
Investigative Site
Chicago, Illinois, United States, 60208
United States, Louisiana
Investigative Site
Baton Rouge, Louisiana, United States, 70808
United States, Massachusetts
Investigative Site
Boston, Massachusetts, United States, 02115
United States, Nevada
Investigative Site
Las Vegas, Nevada, United States, 89401
United States, New York
Investigative Site
New York, New York, United States, 10065
United States, North Carolina
Investigative Site
Raleigh, North Carolina, United States, 27612
United States, Ohio
Investigative Site
Cincinnati, Ohio, United States, 45219
Investigative Site
Columbus, Ohio, United States, 43212
Investigative Site
Columbus, Ohio, United States, 43213
United States, Pennsylvania
Investigative Site
Danville, Pennsylvania, United States, 17822
United States, Tennessee
Investigative Site
Nashville, Tennessee, United States, 37203
United States, Texas
Investigative Site
Dallas, Texas, United States, 75246
Investigative Site
Round Rock, Texas, United States, 78681
United States, Utah
Investigative Site
West Jordan, Utah, United States, 84088
United States, Virginia
Investigative Site
Norfolk, Virginia, United States, 23606
Investigative Site
Richmond, Virginia, United States, 23294
Canada, Ontario
Investigative Site
Ottawa, Ontario, Canada, K1N 6N5
Canada, Quebec
Investigative Site
Québec, Quebec, Canada, G1V 0A6
Czechia
Investigative Site
Hradec, Czechia, 500 00
Investigative Site
Prague, Czechia, 121 08
Investigative Site
Prague, Czechia, 140 00
Investigative Site
Prague, Czechia, 182 00
Denmark
Investigative Site
Copenhagen, Denmark, DK-1958
Italy
Investigative Site
Milan, Milanese, Italy, 20097
Investigative Site
Naples, Italy, 80131
Investigative Site
Rome, Italy, 00161
Spain
Investigative Site
Pamplona, Spain, 31008
Sponsors and Collaborators
Gelesis, Inc.
Investigators
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Study Director: Hassan M Heshmati, MD Chief Medical Officer
  Study Documents (Full-Text)

Documents provided by Gelesis, Inc.:
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Responsible Party: Gelesis, Inc.
ClinicalTrials.gov Identifier: NCT02307279    
Other Study ID Numbers: G-04
First Posted: December 4, 2014    Key Record Dates
Results First Posted: August 30, 2022
Last Update Posted: August 30, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Overweight
Body Weight