Effect of GSP3 on Body Weight in Overweight and Obese Subjects

Obesity Clinical Trial

— FLOW  

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of GSP3 on Body Weight in Overweight and Obese Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03008954
• Other study ID #: Attiva-03
• Status: Completed
• Phase: N/A
• Start date: July 2012
• Est. completion date: February 2013

Study information

• Verified date: February 2018
• Source: Gelesis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The FLOW (First Loss Of Weight) study is designed to assess the effects of repeated administration of GSP3, an investigational product, on body weight. It is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose study. FLOW is being conducted in 5 medical centers in Italy, Czech Republic, and Denmark, and will randomize 123 overweight and obese adult males and females to receive either placebo, GSP3 (2.25g), or GSP3 (3.75g) in addition to a hypocaloric diet (-600 kcal/day) for 12 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

1. Body Mass Index (BMI) = 27 and = 35 (at least 30% overweight and 30% obese subjects)

2. Ability to follow verbal and written instructions

3. Informed Consent Form signed by the subjects

Exclusion Criteria:

1. Pregnancy 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; bilateral tubal ligation and vasectomy are not acceptable contraceptive methods)

3. History of allergic reaction to carboxymethylcellulose, citric acid, modified cellulose, microcrystalline cellulose, and gelatin

4. Administration of investigational products within 1 month prior to Screening Visit

5. Night-shift workers

6. Subjects who stopped smoking within 6 months prior to Screening Visit or considering smoking cessation during the study

7. Subjects anticipating surgical intervention during the study

8. Known type 1 or type 2 diabetes

9. History of eating disorders including binge eating (except mild binge eater)

10. Weight change > 3 kg within 3 months prior to and during the Screening period

11. Supine systolic blood pressure (SBP) > 150 mm Hg and/or supine diastolic blood pressure (DBP) > 90 mm Hg

12. Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit

13. History of gastroesophageal reflux disease

14. History of gastric or duodenal ulcer

15. History of gastroparesis

16. History of gastric bypass or any other gastric surgery

17. History of intragastric balloon

18. History of pancreatitis

19. History of hemorrhoids

20. History of malabsorption

21. Laxative users

22. History of hepatitis B or C

23. History of human immunodeficiency virus

24. History of cancer within the past 5 years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)

25. Any other clinically significant disease interfering with the assessments of Attiva, according to the Investigator

26. Positive serum or urine pregnancy test(s) in females of childbearing potential

27. Plasma glucose = 126 mg/dL (7.0 mmol/L)

28. Abnormal serum thyrotropin (TSH)

29. Serum triglycerides > 500 mg/dL (5.65 mmol/L)

30. Positive test for drugs in the urine

31. Any relevant biochemical abnormality interfering with the assessments of Attiva, according to the Investigator

32. Anti-obesity medications (including herbal preparations) within 1 month prior to Screening Visit

33. Systemic corticosteroids within 1 month prior to Screening Visit

34. Thyroid hormones or preparations within 1 month prior to Screening Visit (except in subjects on stable dose of replacement therapy for at least 1 month)

35. Any other medication known to cause weight loss or weight gain within 1 month prior to Screening Visit

36. Medications treating hypertension within 1 month prior to Screening Visit

37. Medications treating dyslipidemia within 1 month prior to Screening Visit

38. Anticipated requirement for use of prohibited concomitant medications

Related Conditions & MeSH terms

• Body Weight
• Obesity
• Overweight

Intervention

Device:
• GSP3
Each capsule of GSP3 (previously Attiva) contains 700 mg of a mixture of two food-grade materials: carboxymethylcellulose that is cross-linked with citric acid.

Dietary Supplement:
• Avicel (modified Cellulose)
Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose

Locations

Country	Name	City	State
Czechia	Hradec Králové	Hradec
Czechia	Charles University	Prague
Denmark	University of Cophenhagen	Copenhagen
Italy	Federico University Hospital	Naples
Italy	Policlinico Umberto I	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Gelesis, Inc.

Countries where clinical trial is conducted

Czechia,  Denmark,  Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in plasma glucose	Change from baseline in millimoles per liter (mmol/L)	Measured at baseline and week 13
Other	Change in plasma glucose status (normal, impaired, diabetic)		Measured at weeks 0 and 13
Other	Change in serum insulin	Change from baseline in miliunits per liter (mU/L)	Measured at weeks 0 and 13
Other	Change in insulin resistance	Change from baseline in homeostatic model assessment of insulin resistance (HOMA-IR)	Measured at weeks 0 and 13
Other	Change in glycosylated hemoglobin (HbA1c)	Measured in percentage (%)	Measured at weeks 0 and 13
Other	Change in total cholesterol, serum low-density lipoprotein (LDL), high-density lipoprotein (HDL), total cholesterol/HDL ratio, and triglycerides	measured in mg/dL	Measured at weeks 0 and 13
Other	Change vital signs: heart rate, supine and standing systolic and diastolic blood pressure (SBP, DBP)	Measured in beats per minute (heart rate) or millimeters of mercury (mmHg) for blood pressure	Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Other	All adverse events (AE), serious adverse events (SAE), and gastrointestinal symptoms	Number and % of subjects with AE/SAEs spontaneously reported; gastrointestinal symptoms solicited via questionnaire	Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Other	Change in serum sodium	Change from baseline in millimoles per liter (mmol/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in serum potassium	Change from baseline (mmol/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in serum coloride	Change from baseline (mmol/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in serum calcium	Change from baseline (mmol/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in serum magnesium	Change from baseline (mmol/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in serum phosphorus	Change from baseline (mmol/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in serum glucose	Change from baseline (mmol/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in blood urea nitrogen (BUN)	Change from baseline (mmol/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in serum creatinine	Change from baseline in micromoles per liter (umol/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in serum uric acid	Change from baseline (umol/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in total bilirubin	Change from baseline (umol/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in alanine aminotransferase (ALT)	Change from baseline in international units per liter (IU/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in aspartate transaminase (AST)	Change from baseline (IU/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in gamma-glutamyl transpeptidase (GGT)	Change from baseline (IU/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in alkaline phosphatase (ALP)	Change from baseline (IU/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in serum total protein	Change from baseline in grams per liter (g/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in serum albumin	Change from baseline (g/L)	Measured at weeks 0,4,8,12,13 and follow up (week 14)
Other	Change in hematocrit	Change from baseline (%)	Measured at weeks 0,4,8,12,13 and follow-up (week 14)
Other	Change in hemoglobin	Change from baseline (%)	Measured at weeks 0,4,8,12,13 and follow-up (week 14)
Primary	Change in Body Weight	Change from baseline in kilograms and percent (%) weight	Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Secondary	Body weight responders	Change from baseline in body weight of at least 5%	12 weeks
Secondary	Change in waist circumference	Change from baseline in waist circumference (centimeters)	Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Secondary	Change in fat mass	Change in percentage (%) of total mas from baseline in fat- and bone-free fat mass measured by dual energy X-ray absorptiometry (DEXA)	Measured at weeks 0 and 13
Secondary	Change in bone-free fat mass	Change in percentage (%) of total mas from baseline in fat- and bone-free fat mass measured by dual energy X-ray absorptiometry (DEXA)	Measured at weeks 0 and 13
Secondary	Change in appetite (hunger, satiety, and fullness)	Assessed by self-administered Visual Analog Scale (VAS)	Measured at weeks 0,1,2,4,6,8,10,12,13, and follow up (week 14)
Secondary	Change in food intake	Assessed by 24 hr dietary recall	Measured at weeks 0 and 12