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Study of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes

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ClinicalTrials.gov Identifier: NCT02307279
Recruitment Status : Completed
First Posted : December 4, 2014
Last Update Posted : November 28, 2018
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.

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: Placebo-adjusted percent weight loss [ Time Frame: Percentage change from Baseline to Day 171 ]
    super-superiority margin of 3% in addition to superiority as of 02/2016

  2. Co-Primary Outcome: Weight loss of at least 5% in greater than or equal to 35% of subjects on Gelesis100 [ Time Frame: 5% weight loss from Baseline to Day 171 ]

Secondary Outcome Measures :
  1. Percent body weight change in subjects with impaired plasma glucose status at baseline [ Time Frame: Baseline to Day 171 ]
  2. Change in plasma glucose status (normal, impaired, diabetic) in subjects with impaired plasma glucose status at baseline [ Time Frame: Baseline to Day 171 ]
  3. Percent change in plasma glucose in subjects with impaired plasma glucose status and type 2 diabetes at baseline [ Time Frame: Baseline to Day 171 ]
  4. Change in BMI [ Time Frame: Baseline to Day 171 ]
  5. Change in HbA1c in subjects with type 2 diabetes at baseline [ Time Frame: Baseline to Day 171 ]

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



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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


  Show 36 Study Locations
Sponsors and Collaborators
Gelesis, Inc.
Investigators
Study Director: Hassan M Heshmati, MD Chief Medical Officer

Responsible Party: Gelesis, Inc.
ClinicalTrials.gov Identifier: NCT02307279     History of Changes
Other Study ID Numbers: G-04
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms