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

Sponsor
Gelesis, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02307279
Collaborator
(none)
436
Enrollment
36
Locations
2
Arms
31
Actual Duration (Months)
12.1
Patients Per Site
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Gelesis100
  • Device: placebo
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
436 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Jun 1, 2017
Actual Study Completion Date :
Jun 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Experimental: Gelesis100

Gelesis100 twice daily

Device: Gelesis100
Placebo Comparator: Placebo

Matching placebo twice daily

Device: placebo

Outcome Measures

Primary Outcome Measures

  1. Co-Primary Outcome: Placebo-adjusted percent weight loss [Percentage change from Baseline to Day 171]

    super-superiority margin of 3% in addition to superiority as of 02/2016

  2. 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 to Day 171]

Secondary Outcome Measures

  1. Percent body weight change in subjects with impaired plasma glucose status at baseline [Baseline to Day 171]

  2. Change in plasma glucose status (normal, impaired, diabetic) in subjects with impaired plasma glucose status at baseline [Baseline to Day 171]

  3. Percent change in plasma glucose in subjects with impaired plasma glucose status and type 2 diabetes at baseline [Baseline to Day 171]

  4. Change in BMI [Baseline to Day 171]

  5. Change in HbA1c in subjects with type 2 diabetes at baseline [Baseline to Day 171]

Other Outcome Measures

  1. Assess safety and tolerability of administration of Gelesis100 [Baseline to Day 197]

    Adverse Events (AEs), Physical Examinations, Vital Signs, Laboratory Tests

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Investigative Site Anaheim California United States 92801
2 Investigative Site San Diego California United States 92103
3 Investigative Site Tustin California United States 92780
4 Investigative Site Walnut Creek California United States 94598
5 Investigative Site West Hills California United States 91307
6 Investigative Site Aurora Colorado United States 80045
7 Investigative Site Jacksonville Florida United States 32205
8 Investigative Site Miami Florida United States 33143
9 Investigative Site Boise Idaho United States 83642
10 Investigative Site Chicago Illinois United States 60208
11 Investigative Site Baton Rouge Louisiana United States 70808
12 Investigative Site Boston Massachusetts United States 02115
13 Investigative Site Las Vegas Nevada United States 89401
14 Investigative Site New York New York United States 10065
15 Investigative Site Raleigh North Carolina United States 27612
16 Investigative Site Cincinnati Ohio United States 45219
17 Investigative Site Columbus Ohio United States 43212
18 Investigative Site Columbus Ohio United States 43213
19 Investigative Site Danville Pennsylvania United States 17822
20 Investigative Site Nashville Tennessee United States 37203
21 Investigative Site Dallas Texas United States 75246
22 Investigative Site Round Rock Texas United States 78681
23 Investigative Site West Jordan Utah United States 84088
24 Investigative Site Norfolk Virginia United States 23606
25 Investigative Site Richmond Virginia United States 23294
26 Investigative Site Ottawa Ontario Canada K1N 6N5
27 Investigative Site Québec Quebec Canada G1V 0A6
28 Investigative Site Hradec Czechia 500 00
29 Investigative Site Prague Czechia 121 08
30 Investigative Site Prague Czechia 140 00
31 Investigative Site Prague Czechia 182 00
32 Investigative Site Copenhagen Denmark DK-1958
33 Investigative Site Milan Milanese Italy 20097
34 Investigative Site Naples Italy 80131
35 Investigative Site Rome Italy 00161
36 Investigative Site Pamplona Spain 31008

Sponsors and Collaborators

  • Gelesis, Inc.

Investigators

  • Study Director: Hassan M Heshmati, MD, Chief Medical Officer

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Gelesis, Inc.
ClinicalTrials.gov Identifier:
NCT02307279
Other Study ID Numbers:
  • G-04
First Posted:
Dec 4, 2014
Last Update Posted:
Sep 11, 2019
Last Verified:
Sep 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Additional relevant MeSH terms:
Overweight
Body Weight

Study Results

No Results Posted as of Sep 11, 2019