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

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Overweight
• Intervention / Treatment: Device: Gelesis100; Device: placebo

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
• Enrollment (Actual): 436
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1N 6N5
      • Investigative Site
  • Quebec
    • Québec, Quebec, Canada, G1V 0A6
      • Investigative Site
• Czechia
  • Hradec, Czechia, 500 00
    • Investigative Site
  • Prague, Czechia, 121 08
    • Investigative Site
  • Prague, Czechia, 140 00
    • Investigative Site
  • Prague, Czechia, 182 00
    • Investigative Site
• Denmark
  • Copenhagen, Denmark, DK-1958
    • Investigative Site
• Italy
  • Naples, Italy, 80131
    • Investigative Site
  • Rome, Italy, 00161
    • Investigative Site
  • Milanese
    • Milan, Milanese, Italy, 20097
      • Investigative Site
• Spain
  • Pamplona, Spain, 31008
    • Investigative Site
• United States
  • California
    • 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
      • Investigative Site
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Investigative Site
  • Florida
    • Jacksonville, Florida, United States, 32205
      • Investigative Site
    • Miami, Florida, United States, 33143
      • Investigative Site
  • Idaho
    • Boise, Idaho, United States, 83642
      • Investigative Site
  • Illinois
    • Chicago, Illinois, United States, 60208
      • Investigative Site
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Investigative Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Investigative Site
  • Nevada
    • Las Vegas, Nevada, United States, 89401
      • Investigative Site
  • New York
    • New York, New York, United States, 10065
      • Investigative Site
  • North Carolina
    • Raleigh, North Carolina, United States, 27612
      • Investigative Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • Investigative Site
    • Columbus, Ohio, United States, 43212
      • Investigative Site
    • Columbus, Ohio, United States, 43213
      • Investigative Site
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822
      • Investigative Site
  • Tennessee
    • Nashville, Tennessee, United States, 37203
      • Investigative Site
  • Texas
    • Dallas, Texas, United States, 75246
      • Investigative Site
    • Round Rock, Texas, United States, 78681
      • Investigative Site
  • Utah
    • West Jordan, Utah, United States, 84088
      • Investigative Site
  • Virginia
    • Norfolk, Virginia, United States, 23606
      • Investigative Site
    • Richmond, Virginia, United States, 23294
      • Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Gelesis100; Gelesis100 twice daily	Device: Gelesis100
Placebo Comparator: Placebo; Matching placebo twice daily	Device: placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Co-Primary Outcome: Percent Change in Body Weight	Percent change in body weight from Baseline to Day 171 is presented.	Baseline to Day 171
Co-Primary Outcome: Percentage of Subjects Who Achieve Body Weight Loss ≥ 5%	Percentage of participants who achieve a body weight loss ≥ 5% from Baseline to Day 171 is presented.	Baseline to Day 171

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Body Weight Change in Subjects With Impaired Plasma Glucose Status at Baseline	Impaired plasma glucose status is defined as Fasting Plasma Glucose (FPG) ≥100mg/dL and <126mg/dL at baseline measurement.	Baseline to Day 171
Change in Plasma Glucose Status (Normal, Impaired, Diabetic) in Subjects With Impaired Plasma Glucose Status at Baseline.	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.	Baseline to Day 171
Percent Change in Plasma Glucose	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.	Baseline to Day 171
Change in Body Mass Index (BMI)	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).	Baseline to Day 171
Change in Hemoglobin HbA1c in Subjects With Type 2 Diabetes at Baseline	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.	Baseline to Day 171

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess Safety and Tolerability of Administration of Gelesis100	Adverse Events (AEs), Physical Examinations, Vital Signs, Laboratory Tests	Baseline to Day 197

Collaborators and Investigators

• Sponsor: Gelesis, Inc.
• Investigators: Study Director: Hassan M Heshmati, MD, Chief Medical Officer

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2014
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: November 26, 2014
• First Submitted That Met QC Criteria: December 1, 2014
• First Posted (Estimate): December 4, 2014

Study Record Updates

• Last Update Posted (Actual): August 30, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overweight; Body Weight
• Other Study ID Numbers: G-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No