Trial Outcomes & Findings for Study of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes (NCT NCT02307279)
NCT ID: NCT02307279
Last Updated: 2022-08-30
Results Overview
Percent change in body weight from Baseline to Day 171 is presented.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
436 participants
Primary outcome timeframe
Baseline to Day 171
Results posted on
2022-08-30
Participant Flow
Participant milestones
| Measure |
Gelesis100
Gelesis100 twice daily
Gelesis100
|
Placebo
Matching placebo twice daily
placebo
|
|---|---|---|
|
Overall Study
STARTED
|
223
|
213
|
|
Overall Study
COMPLETED
|
172
|
152
|
|
Overall Study
NOT COMPLETED
|
51
|
61
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Gelesis100 on Body Weight in Overweight and Obese Subjects With and Without Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
Gelesis100
n=223 Participants
Gelesis100 twice daily
Gelesis100
|
Placebo
n=213 Participants
Matching placebo twice daily
placebo
|
Total
n=436 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
223 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
436 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
125 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
245 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
98 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
212 Participants
n=5 Participants
|
197 Participants
n=7 Participants
|
409 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
189 Participants
n=5 Participants
|
180 Participants
n=7 Participants
|
369 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
26 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
Europe
|
126 participants
n=5 Participants
|
119 participants
n=7 Participants
|
245 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
97 participants
n=5 Participants
|
94 participants
n=7 Participants
|
191 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 171Population: Overall number of patients analyzed is equal to the intention to treat population (all randomized subjects).
Percent change in body weight from Baseline to Day 171 is presented.
Outcome measures
| Measure |
Gelesis100
n=223 Participants
Gelesis100 twice daily
Gelesis100
|
Placebo
n=213 Participants
Matching placebo twice daily
placebo
|
|---|---|---|
|
Co-Primary Outcome: Percent Change in Body Weight
|
-6.41 percentage change in body weight
Standard Deviation 5.79
|
-4.39 percentage change in body weight
Standard Deviation 5.52
|
PRIMARY outcome
Timeframe: Baseline to Day 171Population: Overall Number of Participants Analyzed is equal to the intention to treat population (all randomized subjects).
Percentage of participants who achieve a body weight loss ≥ 5% from Baseline to Day 171 is presented.
Outcome measures
| Measure |
Gelesis100
n=223 Participants
Gelesis100 twice daily
Gelesis100
|
Placebo
n=213 Participants
Matching placebo twice daily
placebo
|
|---|---|---|
|
Co-Primary Outcome: Percentage of Subjects Who Achieve Body Weight Loss ≥ 5%
|
58.6 percentage of participants
|
42.2 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to Day 171Population: Overall Number of Participants Analyzed is equal to the number of participants with impaired fasting glucose at Baseline.
Impaired plasma glucose status is defined as Fasting Plasma Glucose (FPG) ≥100mg/dL and \<126mg/dL at baseline measurement.
Outcome measures
| Measure |
Gelesis100
n=59 Participants
Gelesis100 twice daily
Gelesis100
|
Placebo
n=58 Participants
Matching placebo twice daily
placebo
|
|---|---|---|
|
Percent Body Weight Change in Subjects With Impaired Plasma Glucose Status at Baseline
|
-6.46 percentage change in body weight
Standard Deviation 6.28
|
-5.54 percentage change in body weight
Standard Deviation 6.08
|
SECONDARY outcome
Timeframe: Baseline to Day 171Population: Overall Number of Participants Analyzed is equal to the number of participants with impaired fasting glucose 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.
Outcome measures
| Measure |
Gelesis100
n=59 Participants
Gelesis100 twice daily
Gelesis100
|
Placebo
n=58 Participants
Matching placebo twice daily
placebo
|
|---|---|---|
|
Change in Plasma Glucose Status (Normal, Impaired, Diabetic) in Subjects With Impaired Plasma Glucose Status at Baseline.
Diabetic
|
1 participants
|
5 participants
|
|
Change in Plasma Glucose Status (Normal, Impaired, Diabetic) in Subjects With Impaired Plasma Glucose Status at Baseline.
Normal
|
23 participants
|
19 participants
|
|
Change in Plasma Glucose Status (Normal, Impaired, Diabetic) in Subjects With Impaired Plasma Glucose Status at Baseline.
Impaired (Pre-diabetic)
|
35 participants
|
34 participants
|
SECONDARY outcome
Timeframe: Baseline to Day 171Population: Overall Number of Participants Analyzed is equal to the number of participants with impaired fasting glucose at Baseline.
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.
Outcome measures
| Measure |
Gelesis100
n=59 Participants
Gelesis100 twice daily
Gelesis100
|
Placebo
n=58 Participants
Matching placebo twice daily
placebo
|
|---|---|---|
|
Percent Change in Plasma Glucose
|
-2.39 percentage of change in plasma glucose
Standard Deviation 20.55
|
-1.95 percentage of change in plasma glucose
Standard Deviation 14.61
|
SECONDARY outcome
Timeframe: Baseline to Day 171Population: Overall number of patients analyzed is equal to the number of all participants with available data.
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).
Outcome measures
| Measure |
Gelesis100
n=223 Participants
Gelesis100 twice daily
Gelesis100
|
Placebo
n=213 Participants
Matching placebo twice daily
placebo
|
|---|---|---|
|
Change in Body Mass Index (BMI)
|
-2.12 kg/m^2
Standard Deviation 1.92
|
-1.51 kg/m^2
Standard Deviation 1.90
|
SECONDARY outcome
Timeframe: Baseline to Day 171Population: Overall number of patients analyzed is equal to the number of all participants 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.
Outcome measures
| Measure |
Gelesis100
n=21 Participants
Gelesis100 twice daily
Gelesis100
|
Placebo
n=25 Participants
Matching placebo twice daily
placebo
|
|---|---|---|
|
Change in Hemoglobin HbA1c in Subjects With Type 2 Diabetes at Baseline
|
-0.64 mmol/mol
Standard Deviation 5.07
|
-3.06 mmol/mol
Standard Deviation 4.18
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline to Day 197Adverse Events (AEs), Physical Examinations, Vital Signs, Laboratory Tests
Outcome measures
Outcome data not reported
Adverse Events
Gelesis100
Serious events: 0 serious events
Other events: 159 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 149 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gelesis100
n=223 participants at risk
Gelesis100 twice daily
Gelesis100
|
Placebo
n=211 participants at risk
Matching placebo twice daily
placebo
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon Adenoma
|
0.00%
0/223 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
0.47%
1/211 • Number of events 1 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
Other adverse events
| Measure |
Gelesis100
n=223 participants at risk
Gelesis100 twice daily
Gelesis100
|
Placebo
n=211 participants at risk
Matching placebo twice daily
placebo
|
|---|---|---|
|
Gastrointestinal disorders
Abdominal Distention
|
11.7%
26/223 • Number of events 27 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
6.6%
14/211 • Number of events 14 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
12/223 • Number of events 12 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
2.8%
6/211 • Number of events 6 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
|
Gastrointestinal disorders
Constipation
|
5.4%
12/223 • Number of events 13 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
5.2%
11/211 • Number of events 11 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
|
Gastrointestinal disorders
Diarrhoea
|
12.6%
28/223 • Number of events 31 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
8.5%
18/211 • Number of events 20 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
|
Gastrointestinal disorders
Flatulence
|
8.5%
19/223 • Number of events 21 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
5.2%
11/211 • Number of events 14 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
|
Gastrointestinal disorders
Infrequent bowel movements
|
9.4%
21/223 • Number of events 24 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
4.7%
10/211 • Number of events 12 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
|
Gastrointestinal disorders
Nausea
|
4.9%
11/223 • Number of events 12 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
5.2%
11/211 • Number of events 12 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
|
Infections and infestations
Nasopharyngitis
|
11.7%
26/223 • Number of events 31 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
14.2%
30/211 • Number of events 37 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
|
Infections and infestations
Upper respiratory tract infections
|
3.6%
8/223 • Number of events 9 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
5.7%
12/211 • Number of events 14 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
7/223 • Number of events 9 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
6.2%
13/211 • Number of events 13 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
|
Nervous system disorders
Headache
|
7.2%
16/223 • Number of events 23 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
8.5%
18/211 • Number of events 26 • 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.
AE reported by subjects are recorded and discussed in detail by the investigator at each visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place