Clinical trial NCT02307279: Study of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: Gelesis, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-04
Enrollment: 436
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Co-Primary Outcome: Percent Change in Body Weight
timeFrame: Baseline to Day 171
measure: Co-Primary Outcome: Percentage of Subjects Who Achieve Body Weight Loss ≥ 5%
timeFrame: Baseline to Day 171
Secondary outcomes:
measure: Percent Body Weight Change in Subjects With Impaired Plasma Glucose Status at Baseline
timeFrame: Baseline to Day 171
measure: Change in Plasma Glucose Status (Normal, Impaired, Diabetic) in Subjects With Impaired Plasma Glucose Status at Baseline.
timeFrame: Baseline to Day 171
measure: Percent Change in Plasma Glucose
timeFrame: Baseline to Day 171
measure: Change in Body Mass Index (BMI)
timeFrame: Baseline to Day 171
measure: Change in Hemoglobin HbA1c in Subjects With Type 2 Diabetes at Baseline
timeFrame: Baseline to Day 171
Other outcomes:
measure: Assess Safety and Tolerability of Administration of Gelesis100
timeFrame: Baseline to Day 197
Locations:
city: Anaheim
country: United States
facility: Investigative Site
state: California
city: San Diego
country: United States
facility: Investigative Site
state: California
city: Tustin
country: United States
facility: Investigative Site
state: California
city: Walnut Creek
country: United States
facility: Investigative Site
state: California
city: West Hills
country: United States
facility: Investigative Site
state: California
city: Aurora
country: United States
facility: Investigative Site
state: Colorado
city: Jacksonville
country: United States
facility: Investigative Site
state: Florida
city: Miami
country: United States
facility: Investigative Site
state: Florida
city: Boise
country: United States
facility: Investigative Site
state: Idaho
city: Chicago
country: United States
facility: Investigative Site
state: Illinois
city: Baton Rouge
country: United States
facility: Investigative Site
state: Louisiana
city: Boston
country: United States
facility: Investigative Site
state: Massachusetts
city: Las Vegas
country: United States
facility: Investigative Site
state: Nevada
city: New York
country: United States
facility: Investigative Site
state: New York
city: Raleigh
country: United States
facility: Investigative Site
state: North Carolina
city: Cincinnati
country: United States
facility: Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Investigative Site
state: Ohio
city: Columbus
country: United States
facility: Investigative Site
state: Ohio
city: Danville
country: United States
facility: Investigative Site
state: Pennsylvania
city: Nashville
country: United States
facility: Investigative Site
state: Tennessee
city: Dallas
country: United States
facility: Investigative Site
state: Texas
city: Round Rock
country: United States
facility: Investigative Site
state: Texas
city: West Jordan
country: United States
facility: Investigative Site
state: Utah
city: Norfolk
country: United States
facility: Investigative Site
state: Virginia
city: Richmond
country: United States
facility: Investigative Site
state: Virginia
city: Ottawa
country: Canada
facility: Investigative Site
state: Ontario
city: Québec
country: Canada
facility: Investigative Site
state: Quebec
city: Hradec
country: Czechia
facility: Investigative Site
city: Prague
country: Czechia
facility: Investigative Site
city: Prague
country: Czechia
facility: Investigative Site
city: Prague
country: Czechia
facility: Investigative Site
city: Copenhagen
country: Denmark
facility: Investigative Site
city: Milan
country: Italy
facility: Investigative Site
state: Milanese
city: Naples
country: Italy
facility: Investigative Site
city: Rome
country: Italy
facility: Investigative Site
city: Pamplona
country: Spain
facility: Investigative Site
Study officials:
affiliation: Chief Medical Officer
name: Hassan M Heshmati, MD
role: STUDY_DIRECTOR
References: