CompletedNCT02307279Updated Aug 30, 2022Results posted

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

An interventional study of Gelesis100 and placebo in Overweight and Obesity, sponsored by Gelesis, Inc.. Completed at 36 sites in 6 countries. Open to participants aged 22 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-08-30.

Sponsored by Gelesis, Inc. · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 436
Allocation: Randomized
Ages: 22 Years to 65 Years
Sex: All

Study 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.

Read the 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.

Conditions studied

Overweight
Obesity

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In context

Overweight

3,767 studies on the registry are indexed under Overweight; 863 are open to participants now.

This study's enrollment of 436 is above the median of 73 across 3,263 interventional studies indexed under Overweight.

Browse Overweight studies →

Lead sponsor

Gelesis, Inc. is the lead sponsor of 11 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 22 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 436 participants (actual)

Study arms

Experimental
Gelesis100
Gelesis100 twice daily
Device: Gelesis100
Placebo comparator
Placebo
Matching placebo twice daily
Device: placebo

Interventions

DeviceGelesis100
Deviceplacebo

What researchers measure

Primary outcomes

Co-Primary Outcome: Percent Change in Body Weight
Percent change in body weight from Baseline to Day 171 is presented.
Time frame: Baseline to Day 171
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.
Time frame: Baseline to Day 171

Secondary outcomes

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.
Time frame: Baseline to Day 171
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.
Time frame: Baseline to Day 171
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.
Time frame: Baseline to Day 171
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).
Time frame: Baseline to Day 171
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.
Time frame: Baseline to Day 171

Other outcomes

Assess Safety and Tolerability of Administration of Gelesis100
Adverse Events (AEs), Physical Examinations, Vital Signs, Laboratory Tests
Time frame: Baseline to Day 197

Results

Posted Aug 30, 2022

Participant flow

Participant flow — Overall Study
Milestone	Gelesis100	Placebo
Started	223	213
Completed	172	152
Not completed	51	61

Outcome measures

PrimaryCo-Primary Outcome: Percent Change in Body Weight

Percent change in body weight from Baseline to Day 171 is presented.

Time frame:: Baseline to Day 171
Reported as:: Mean · percentage change in body weight

Co-Primary Outcome: Percent Change in Body Weight
percentage change in body weight	Gelesis100	Placebo
Co-Primary Outcome: Percent Change in Body Weight	-6.41 ± 5.79	-4.39 ± 5.52

Statistical analysis

Gelesis100 vs Placebo · ANCOVA · p = 0.0007 · Mean difference (net): -2.07 · 95% CI -3.24 to -0.90Difference in adjusted mean taken for comparability between the two groups (treatment - placebo)
Gelesis100 vs Placebo · ANCOVA · p = 0.1193Adjusted for stratification factors, and baseline weight

PrimaryCo-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.

Time frame:: Baseline to Day 171
Reported as:: Number · percentage of participants

Co-Primary Outcome: Percentage of Subjects Who Achieve Body Weight Loss ≥ 5%
percentage of participants	Gelesis100	Placebo
Co-Primary Outcome: Percentage of Subjects Who Achieve Body Weight Loss ≥ 5%	58.6	42.2

Statistical analysis

Gelesis100 · Binomial Proportion Test · p = <0.0001
Gelesis100 vs Placebo · Regression, Logistic · p = 0.0008 · Odds ratio (or): 2.01 · 95% CI 1.34 to 3.01Adjusted for stratification factors and baseline weight

SecondaryPercent 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.

Time frame:: Baseline to Day 171
Reported as:: Mean · percentage change in body weight

Percent Body Weight Change in Subjects With Impaired Plasma Glucose Status at Baseline
percentage change in body weight	Gelesis100	Placebo
Percent Body Weight Change in Subjects With Impaired Plasma Glucose Status at Baseline	-6.46 ± 6.28	-5.54 ± 6.08

SecondaryChange 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.

Time frame:: Baseline to Day 171
Reported as:: Number · participants

Change in Plasma Glucose Status (Normal, Impaired, Diabetic) in Subjects With Impaired Plasma Glucose Status at Baseline.
participants	Gelesis100	Placebo
Normal	23	19
Impaired (Pre-diabetic)	35	34
Diabetic	1	5

SecondaryPercent 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.

Time frame:: Baseline to Day 171
Reported as:: Mean · percentage of change in plasma glucose

Percent Change in Plasma Glucose
percentage of change in plasma glucose	Gelesis100	Placebo
Percent Change in Plasma Glucose	-2.39 ± 20.55	-1.95 ± 14.61

SecondaryChange 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).

Time frame:: Baseline to Day 171
Reported as:: Mean · kg/m^2

Change in Body Mass Index (BMI)
kg/m^2	Gelesis100	Placebo
Change in Body Mass Index (BMI)	-2.12 ± 1.92	-1.51 ± 1.90

SecondaryChange 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.

Time frame:: Baseline to Day 171
Reported as:: Mean · mmol/mol

Change in Hemoglobin HbA1c in Subjects With Type 2 Diabetes at Baseline
mmol/mol	Gelesis100	Placebo
Change in Hemoglobin HbA1c in Subjects With Type 2 Diabetes at Baseline	-0.64 ± 5.07	-3.06 ± 4.18

Other pre-specifiedAssess Safety and Tolerability of Administration of Gelesis100

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

Time frame:: Baseline to Day 197

Results for this outcome have not been posted.

Adverse events

Collected over From screening (Day -21) to Day 197. The adverse device effect (AE) and the serious adverse device effects (SAE) are collected since screening until 28 days after the last administration of the investigational medical device.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Gelesis100	0/223 (0%)	0/223 (0%)	159/223 (71.3%)
Placebo	0/211 (0%)	1/211 (0.5%)	149/211 (70.6%)

Most frequent serious events

Most frequent serious events
Event	Gelesis100	Placebo
Colon AdenomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	0/223	1/211

Most frequent other events

Showing 10 of 11

Most frequent other events
Event	Gelesis100	Placebo
NasopharyngitisInfections and infestations	26/223	30/211
DiarrhoeaGastrointestinal disorders	28/223	18/211
Abdominal DistentionGastrointestinal disorders	26/223	14/211
Infrequent bowel movementsGastrointestinal disorders	21/223	10/211
HeadacheNervous system disorders	16/223	18/211
FlatulenceGastrointestinal disorders	19/223	11/211
ArthralgiaMusculoskeletal and connective tissue disorders	7/223	13/211
Upper respiratory tract infectionsInfections and infestations	8/223	12/211
Abdominal painGastrointestinal disorders	12/223	6/211
ConstipationGastrointestinal disorders	12/223	11/211

Baseline characteristics

All 436 randomized subjects were included in the ITT population and 434 (99.5%) subjects were included in the Safety Population. Two randomized subjects never received IP and were excluded from the Safety Population.

Age, Categorical
Age, Categorical(Participants)	Gelesis100	Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	223	213	436
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	Gelesis100	Placebo	Total
Female	125	120	245
Male	98	93	191

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Gelesis100	Placebo	Total
Hispanic or Latino	11	16	27
Not Hispanic or Latino	212	197	409
Unknown or Not Reported	0	0	0

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Gelesis100	Placebo	Total
White	189	180	369
Black or African American	26	24	50
Asian	4	4	8
Other	2	5	7
American Indian or Alaska Native	1	0	1
Native Hawaiian or Other Pacific Islander	1	0	1

Region of Enrollment
Region of Enrollment(participants)	Gelesis100	Placebo	Total
Europe	126	119	245
United States	97	94	191

Study locations

36 sites

Investigative Site
Anaheim, California 92801, United States
Investigative Site
San Diego, California 92103, United States
Investigative Site
Tustin, California 92780, United States
Investigative Site
Walnut Creek, California 94598, United States
Investigative Site
West Hills, California 91307, United States
Investigative Site
Aurora, Colorado 80045, United States
Investigative Site
Jacksonville, Florida 32205, United States
Investigative Site
Miami, Florida 33143, United States
Investigative Site
Boise, Idaho 83642, United States
Investigative Site
Chicago, Illinois 60208, United States
Investigative Site
Baton Rouge, Louisiana 70808, United States
Investigative Site
Boston, Massachusetts 02115, United States
Investigative Site
Las Vegas, Nevada 89401, United States
Investigative Site
New York, New York 10065, United States
Investigative Site
Raleigh, North Carolina 27612, United States
Investigative Site
Cincinnati, Ohio 45219, United States
Investigative Site
Columbus, Ohio 43212, United States
Investigative Site
Columbus, Ohio 43213, United States
Investigative Site
Danville, Pennsylvania 17822, United States
Investigative Site
Nashville, Tennessee 37203, United States
Investigative Site
Dallas, Texas 75246, United States
Investigative Site
Round Rock, Texas 78681, United States
Investigative Site
West Jordan, Utah 84088, United States
Investigative Site
Norfolk, Virginia 23606, United States
Investigative Site
Richmond, Virginia 23294, United States
Investigative Site
Ottawa, Ontario K1N 6N5, Canada
Investigative Site
Québec, Quebec G1V 0A6, Canada
Investigative Site
Hradec, 500 00, Czechia
Investigative Site
Prague, 121 08, Czechia
Investigative Site
Prague, 140 00, Czechia
Investigative Site
Prague, 182 00, Czechia
Investigative Site
Copenhagen, DK-1958, Denmark
Investigative Site
Milan, Milanese 20097, Italy
Investigative Site
Naples, 80131, Italy
Investigative Site
Rome, 00161, Italy
Investigative Site
Pamplona, 31008, Spain

References and documents

Study documents

Protocol and statistical analysis plan · Aug 24, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2014 to primary completion in Jun 2017, 31 months.

Results were first posted in Aug 2022, 5 years 2 months after primary completion. A results delay was requested in May 2019.

Of 116 industry-sponsored interventional studies with no phase under Overweight, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 24. This study's 31 months is above that.

Counting every sponsor, half of 1,472 studies reached it within 17 months; a quarter within 7 and three quarters within 36.

How these figures are worked out, and which studies are left out of them.

Registered: Nov 26, 2014
First posted: Dec 4, 2014
StartActual: Nov 2014
Primary completionActual: Jun 2017
CompletionActual: Jun 2017
Results delay requested: May 14, 2019
Results first posted: Aug 30, 2022
Last update: Aug 30, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Aug 30, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02307279
Lead sponsor: Gelesis, Inc.
Responsible party: Sponsor
First posted: Dec 4, 2014
Start date: Nov 2014
Primary completion: Jun 2017
Completion: Jun 2017
Results posted: Aug 30, 2022
Last update: Aug 30, 2022

Study contacts

Hassan M Heshmati, MD

study director · Chief Medical Officer

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

View the source record on ClinicalTrials.gov ↗

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