Clinical trial NCT03021291: Extension Study of Gelesis100 on Body Weight
Official title: An Open-label Study Assessing the Effect of Gelesis100 on Weight Loss and Weight Maintenance in Overweight and Obese Subjects Who Completed the GLOW Study (G-04)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Lead sponsor: Gelesis, Inc.
Sponsor class: INDUSTRY
First posted: 2017-01-13
Enrollment: 36
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to assess the effect of Gelesis100 on body weight after an additional exposure of 24 weeks in subjects who completed the 24-week treatment period, and had at least 3% weight loss, in the Gelesis Loss Of Weight GLOW, NCT02307279) study.


Eligibility criteria: Inclusion Criteria:

1. Completion of the GLOW study with at least 3% weight loss
2. Informed Consent Form signed by the subjects at the end of the GLOW study

Exclusion Criteria:

1. Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential) or lactation
2. Absence of medically approved contraceptive methods in females of childbearing potential (e.g., hysterectomy, non-oral contraceptive medications or intrauterine device combined with a barrier method, two combined barrier methods such as diaphragm and condom or spermicide, or condom and spermicide; bilateral tubal ligation and vasectomy are not acceptable contraceptive methods)
3. Subjects considering smoking cessation during the study
4. Subjects anticipating surgical intervention during the study
5. Significant intolerance to the study product during the GLOW study
6. Increase of ≥ 0.5% point (≥ 5.5 mmol/mol) in HbA1c from the Baseline Visit of the GLOW study in subjects with treated or untreated type 2 diabetes if considered clinically relevant, or any increase if HbA1c is \> 8.5% (\> 69 mmol/mol)
7. Increase of ≥ 10% in total cholesterol, low-density lipoprotein (LDL) cholesterol, or triglycerides from the Baseline Visit of the GLOW study in subjects with elevated lipids at the Baseline Visit of the GLOW study if considered clinically relevant, or any increase if serum LDL cholesterol is ≥ 190 mg/dL (≥ 4.93 mmol/L) and/or serum triglycerides are ≥ 500 mg/dL (≥ 5.65 mmol/L)
8. Increase of ≥ 10 mm Hg in supine systolic blood pressure (SBP) and/or supine diastolic blood pressure (DBP) from the Baseline Visit of the GLOW study in subjects with treated or untreated hypertension if considered clinically relevant, or any increase if supine SBP is \> 160 mm Hg and/or supine DBP is \> 95 mm Hg, based on the mean of two consecutive readings
9. Poor subject compliance with the GLOW study procedures and recommendations and/or major protocol deviation
10. Anticipated requirement for use of prohibited concomitant medications

Primary outcomes:
measure: Change in body weight
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Body weight responders (5%)
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Secondary outcomes:
measure: Change in plasma glucose status (normal, impaired, diabetic)
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in plasma glucose
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in insulin resistance
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in glycosylated hemoglobin (HbA1c)
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in body mass index (BMI)
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Other outcomes:
measure: Body weight responders (10%)
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in excess body weight
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in body weight status (normal, overweight, obese)
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in waist circumference
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in serum insulin
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in serum C-reactive protein (CRP)
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in total cholesterol, serum low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol/HDL ratio, and triglycerides
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change vital signs: heart rate, supine and standing systolic and diastolic blood pressure (SBP, DBP)
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in food intake
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in Impact of Weight on Quality Of Life (IWQOL)
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: All adverse events (AE), serious adverse events (SAE), and gastrointestinal symptoms
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in serum sodium
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in serum potassium
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in serum chloride
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in serum calcium
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in serum magnesium
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in serum phosphorus
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in serum glucose
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in blood urea nitrogen (BUN)
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in serum creatinine
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in serum uric acid
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in total bilirubin
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in alanine aminotransferase (ALT)
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in aspartate transaminase (AST)
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in gamma-glutamyl transpeptidase (GGT)
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in alkaline phosphatase (ALP)
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in serum total protein
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in serum albumin
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in hematocrit
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
measure: Change in hemoglobin
timeFrame: Measured at baselines of the GLOW and GLOW-EX study (day 197) and day 339
Locations:
city: San Diego
country: United States
facility: Arternis Institute for Clinical Research
state: California
city: Tustin
country: United States
facility: Clinical Trial Investigators
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Jacksonville
country: United States
facility: Westside Center for Clinical Research
state: Florida
city: Baton Rouge
country: United States
facility: Pennington Biomedical Research
state: Louisiana
city: Boston
country: United States
facility: Boston University Medical Center
state: Massachusetts
city: New York
country: United States
facility: Cornell Weill Medical College
state: New York
city: Cincinnati
country: United States
facility: Radiant Research
state: Ohio
city: Columbus
country: United States
facility: Aventiv Research
state: Ohio
city: Danville
country: United States
facility: Geisinger Health System
state: Pennsylvania
city: Round Rock
country: United States
facility: Texas Diabetes and Endocrinology
state: Texas
city: Prague
country: Czechia
facility: Health & Care SRO
city: Copenhagen
country: Denmark
facility: University of Cophenhagen
city: Milan
country: Italy
facility: IRCCS Policlinico San Donato
city: Rome
country: Italy
facility: University of Rome
city: Pamplona
country: Spain
facility: University of Navarra
Study officials:
affiliation: Gelesis, Inc.
name: Hassan Heshmati, MD
role: STUDY_DIRECTOR
References: