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Effect of GSP3 on Body Weight in Overweight and Obese Subjects

NCT03008954 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2018-05-15

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Gelesis, Inc.

    lead INDUSTRY

Principal Investigators

  • Hassan Heshmati, MD · Gelesis, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-02-28
Completion
2013-02-28

Countries

  • Czechia
  • Denmark
  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03008954 on ClinicalTrials.gov