Effect of GSP3 on Body Weight in Overweight and Obese Subjects

NCT ID: NCT03008954

Last Updated: 2018-05-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2013-02-28

Brief 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.

Conditions

Overweight; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Placebo

Microcyrstalline cellulose (Avicel): provided in 5 capsules (350 mg each), twice daily (BID) prior to lunch and dinner.

Group Type: PLACEBO_COMPARATOR

Avicel (modified Cellulose)

Intervention Type: DIETARY_SUPPLEMENT

Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose

GSP3 (2.25g)

GSP3: provided in 3 capsules (750 mg each), plus 2 placebo capsules (350 mg each), twice daily (BID) prior to lunch and dinner

Group Type: EXPERIMENTAL

GSP3

Intervention Type: DEVICE

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.

Avicel (modified Cellulose)

Intervention Type: DIETARY_SUPPLEMENT

Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose

GSP3 (3.75g)

GSP3: provided in 5 capsules (750 mg each), twice daily (BID) prior to lunch and dinner

Group Type: EXPERIMENTAL

GSP3

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Avicel (modified Cellulose)

Each capsule of Avicel contains approximately 350 mg of microcrystalline cellulose

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gelesis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hassan Heshmati, MD

Role: STUDY_DIRECTOR

Gelesis, Inc.

Locations

Hradec Králové

Hradec, , Czechia

Charles University

Prague, , Czechia

University of Cophenhagen

Copenhagen, , Denmark

Federico University Hospital

Naples, , Italy

Policlinico Umberto I

Rome, , Italy

Countries

Czechia; Denmark; Italy

References

Greenway FL, Aronne LJ, Raben A, Astrup A, Apovian CM, Hill JO, Kaplan LM, Fujioka K, Matejkova E, Svacina S, Luzi L, Gnessi L, Navas-Carretero S, Alfredo Martinez J, Still CD, Sannino A, Saponaro C, Demitri C, Urban LE, Leider H, Chiquette E, Ron ES, Zohar Y, Heshmati HM. A Randomized, Double-Blind, Placebo-Controlled Study of Gelesis100: A Novel Nonsystemic Oral Hydrogel for Weight Loss. Obesity (Silver Spring). 2019 Feb;27(2):205-216. doi: 10.1002/oby.22347. Epub 2018 Nov 13.

Reference Type: DERIVED

PMID: 30421844 (View on PubMed)

Other Identifiers

Attiva-03

Identifier Type: -

Identifier Source: org_study_id