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

NCT02307279 | Completed Results DMC FDA Device

• 1 other identifier: G-04
• Study Type: interventional
• Target: 436
• Locations: 6 countries
• Sites: 36

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Percent Body Weight Change in Subjects With Impaired Plasma Glucose Status at Baseline

  Baseline to Day 171

• Change in Plasma Glucose Status (Normal, Impaired, Diabetic) in Subjects With Impaired Plasma Glucose Status at Baseline.

  Baseline to Day 171

• Percent Change in Plasma Glucose

  Baseline to Day 171

• Change in Body Mass Index (BMI)

  Baseline to Day 171

• Change in Hemoglobin HbA1c in Subjects With Type 2 Diabetes at Baseline

  Baseline to Day 171

Other Outcomes (1)

• Assess Safety and Tolerability of Administration of Gelesis100

  Baseline to Day 197

Study Arms (2)

Gelesis100

EXPERIMENTAL

Gelesis100 twice daily

Device: Gelesis100

Placebo

PLACEBO COMPARATOR

Matching placebo twice daily

Device: placebo

Interventions

Gelesis100 DEVICE

Gelesis100

placebo DEVICE

Placebo

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gelesis, Inc.: lead

Study Sites (36)

Investigative Site

Anaheim, California, 92801, United States

Location

Investigative Site

San Diego, California, 92103, United States

Location

Investigative Site

Tustin, California, 92780, United States

Location

Investigative Site

Walnut Creek, California, 94598, United States

Location

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West Hills, California, 91307, United States

Location

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Aurora, Colorado, 80045, United States

Location

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Jacksonville, Florida, 32205, United States

Location

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Miami, Florida, 33143, United States

Location

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Boise, Idaho, 83642, United States

Location

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Chicago, Illinois, 60208, United States

Location

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Baton Rouge, Louisiana, 70808, United States

Location

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Boston, Massachusetts, 02115, United States

Location

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Las Vegas, Nevada, 89401, United States

Location

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New York, New York, 10065, United States

Location

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Raleigh, North Carolina, 27612, United States

Location

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Cincinnati, Ohio, 45219, United States

Location

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Columbus, Ohio, 43212, United States

Location

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Columbus, Ohio, 43213, United States

Location

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Danville, Pennsylvania, 17822, United States

Location

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Nashville, Tennessee, 37203, United States

Location

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Dallas, Texas, 75246, United States

Location

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Round Rock, Texas, 78681, United States

Location

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West Jordan, Utah, 84088, United States

Location

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Norfolk, Virginia, 23606, United States

Location

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Richmond, Virginia, 23294, United States

Location

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Ottawa, Ontario, K1N 6N5, Canada

Location

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Québec, Quebec, G1V 0A6, Canada

Location

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Hradec, 500 00, Czechia

Location

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Prague, 121 08, Czechia

Location

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Prague, 140 00, Czechia

Location

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Prague, 182 00, Czechia

Location

Investigative Site

Copenhagen, DK-1958, Denmark

Location

Investigative Site

Milan, Milanese, 20097, Italy

Location

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Naples, 80131, Italy

Location

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Rome, 00161, Italy

Location

Investigative Site

Pamplona, 31008, Spain

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Harry Leider, MD, MBA
• Organization: Gelesis

hleider@gelesis.com

(443)934-4906

Study Officials

• Hassan M Heshmati, MD

  Chief Medical Officer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2014
• First Posted: December 4, 2014
• Study Start: November 1, 2014
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 30, 2022
• Results First Posted: August 30, 2022

Record last verified: 2022-08

Locations

ES (1); CZ (4); US (25); DK (1); IT (3); CA (2)