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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02307279
• Other study ID #: G-04
• Status: Completed
• Phase: N/A
• Start date: November 2014
• Est. completion date: June 2017

Study information

• Verified date: August 2022
• Source: Gelesis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 436
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

Device:
• Gelesis100

• placebo

Locations

Country	Name	City	State
Canada	Investigative Site	Ottawa	Ontario
Canada	Investigative Site	Québec	Quebec
Czechia	Investigative Site	Hradec
Czechia	Investigative Site	Prague
Czechia	Investigative Site	Prague
Czechia	Investigative Site	Prague
Denmark	Investigative Site	Copenhagen
Italy	Investigative Site	Milan	Milanese
Italy	Investigative Site	Naples
Italy	Investigative Site	Rome
Spain	Investigative Site	Pamplona
United States	Investigative Site	Anaheim	California
United States	Investigative Site	Aurora	Colorado
United States	Investigative Site	Baton Rouge	Louisiana
United States	Investigative Site	Boise	Idaho
United States	Investigative Site	Boston	Massachusetts
United States	Investigative Site	Chicago	Illinois
United States	Investigative Site	Cincinnati	Ohio
United States	Investigative Site	Columbus	Ohio
United States	Investigative Site	Columbus	Ohio
United States	Investigative Site	Dallas	Texas
United States	Investigative Site	Danville	Pennsylvania
United States	Investigative Site	Jacksonville	Florida
United States	Investigative Site	Las Vegas	Nevada
United States	Investigative Site	Miami	Florida
United States	Investigative Site	Nashville	Tennessee
United States	Investigative Site	New York	New York
United States	Investigative Site	Norfolk	Virginia
United States	Investigative Site	Raleigh	North Carolina
United States	Investigative Site	Richmond	Virginia
United States	Investigative Site	Round Rock	Texas
United States	Investigative Site	San Diego	California
United States	Investigative Site	Tustin	California
United States	Investigative Site	Walnut Creek	California
United States	Investigative Site	West Hills	California
United States	Investigative Site	West Jordan	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Gelesis, Inc.

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Denmark,  Italy,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Assess Safety and Tolerability of Administration of Gelesis100	Adverse Events (AEs), Physical Examinations, Vital Signs, Laboratory Tests	Baseline to Day 197
Primary	Co-Primary Outcome: Percent Change in Body Weight	Percent change in body weight from Baseline to Day 171 is presented.	Baseline to Day 171
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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