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

Obesity Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Obesity
• Overweight

• NCT number: NCT02487602
• Study type: Interventional
• Source: Gelesis, Inc.
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Completion date: July 2016