NCT02487602

A Scintigraphic Study to Investigate the Effect of Gelesis100 on Gastric Emptying in Overweight and Obese Subjects

A Randomized, Partially-blinded, Cross-over Scintigraphic Study to Investigate the Effect of Gelesis100 on Gastric Emptying in Overweight and Obese Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Gelesis, Inc. · Industry
• Sex: Male
• Age: 22 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the gastrointestinal behaviour of a novel weight loss device in vivo to further understand the device's mechanism of action in aiding weight loss.

Detailed description

Gelesis100 is a new, experimental medical device which has been developed by Gelesis, Inc. to aid weight loss in overweight/obese patients by reducing the amount of food required to make them feel full. The device is contained in a capsule which is swallowed with water before a meal. Once swallowed, the capsule dissolves and the capsule contents hydrate and mix with the food in the stomach, creating a feeling of fullness. Four different treatments of up to 5 capsules each will be given to participants during this study. These will be a mixture of the Gelesis100 capsules and capsules which do not contain the device i.e., they are placebo (will contain sucrose \[sugar\]) The study is designed to look at: * The time it takes for the stomach to empty once receiving each treatment * The time it takes for food and Gelesis100 to travel through the intestine * The effects of Gelesis100 on the feeling of satiety (how full participants feel) In order to monitor gastrointestinal behavior, either a small amount of radioactive material will be added to a component of a standard lunch or to the water given with the treatment. The radiation emitted will then be detected as it travels through the GI tract by taking images using a device known as a gamma camera. The procedure is relatively easy and non- invasive.

Conditions

• Overweight
• Obesity

Interventions

Type	Name	Description
DEVICE	Gelesis100	Gelesis100 capsules
OTHER	Placebo	Sucrose (sugar) capsules

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-07-01
• Completion: 2016-07-01
• First posted: 2015-07-01
• Last updated: 2016-08-23

Locations

1 site across 1 country: United Kingdom