NCT03008954

Effect of GSP3 on Body Weight in Overweight and Obese Subjects

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Gelesis, Inc. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2012-07-01
• Primary completion: 2013-02-01
• Completion: 2013-02-01
• First posted: 2017-01-04
• Last updated: 2018-05-15

Locations

5 sites across 3 countries: Czechia, Denmark, Italy