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

Not Applicable

Completed

• Conditions: Overweight; Obesity
• Interventions: Device: Gelesis100; Device: placebo

• Registration Number: NCT02307279
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-11
• Study First Submitted: 2014-11-26
• Study First Submitted QC: 2014-12-01
• Study First Posted: 2014-12-04
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Disposition First Submitted: 2019-05-14
• Disposition First Submitted QC: 2019-05-14
• Disposition First Posted: 2019-05-20
• Results First Submitted: 2022-01-21
• Status Verified: 2022-08
• Results First Submitted QC: 2022-08-08
• Last Update Submitted: 2022-08-08
• Results First Posted: 2022-08-30
• Last Update Posted: 2022-08-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 436

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)

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gelesis100	Gelesis100	Gelesis100 twice daily
Placebo	placebo	Matching placebo twice daily

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Investigative Site; 🇪🇸 Pamplona, Spain