Overview

This trial is active, not recruiting.

Conditions overweight, obesity
Treatments gelesis100, placebo
Sponsor Gelesis, Inc.
Start date November 2014
End date February 2017
Trial size 460 participants
Trial identifier NCT02307279, G-04

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Gelesis100 twice daily
gelesis100
(Placebo Comparator)
Matching placebo twice daily
placebo

Primary Outcomes

Measure
Co-Primary Outcome: Placebo-adjusted weight loss greater than or equal to 3.0% (Percentage change from Baseline)
time frame: Percentage change from Baseline to Day 171
Co-Primary Outcome: Weight loss of at least 5% in greater than or equal to 35% of subjects on Gelesis100 (5% weight loss from baseline)
time frame: 5% weight loss from Baseline to Day 171

Secondary Outcomes

Measure
Assess the decrease in serum insulin from Baseline to Day 171
time frame: Baseline to Day 171
Assess the decrease in insulin resistance (HOMA-IR) from Baseline to Day 171
time frame: Baseline to Day 171
Assess the decrease in plasma glucose from Baseline to Day 171
time frame: Baseline to Day 171
Assess the decrease in HbA1c from Baseline to Day 171
time frame: Baseline to Day 171
Assess safety and tolerability of administration of Gelesis100
time frame: Baseline to Day 171

Eligibility Criteria

Male or female participants from 22 years up to 65 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by Gelesis, Inc..