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

NCT02487602 | Completed

• 1 other identifier: GS-100-006
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (2)

• Gastric emptying kinetics of a radiolabelled meal following administration of two different doses of Gelesis100 and placebo and two different meals

  Scintigraphic images of the radiation emitted by the meal will be obtained using a gamma camera. Time to 50% and 90% emptying will be assessed in addition to amount of radiation remaining in the stomach over time.

  up to 10 hours on each of 3 Assessment Visit days

• GI transit time of a radiolabelled meal following administration of two different doses of Gelesis 100 and placebo and two different meals

  Scintigraphic images of the radiation emitted by the meal will be obtained using a gamma camera. Time to arrival of radiation at the colon will be assessed.

  up to 10 hours on each of 3 Assessment Visit Days

Secondary Outcomes (6)

• Water uptake behavior of Gelesis100

  up to 10 hours on one Assesssment Visit day

• Gastric emptying of Gelesis100

  up to 10 hours on one Assesssment Visit day

• Gastric emptying of a radiolabeled high fat meal when Gelesis100 is taken 10 minutes before the meal

  up to 10 hours on one Assesssment Visit day

• GI transit times of Gelesis100

  up to 10 hours on one Assesssment Visit day

• GI transit times of a high fat radiolabeled meal when Gelesis100 is taken 10 minutes before the meal

  up to 10 hours on one Assesssment Visit day

Study Arms (5)

A

ACTIVE COMPARATOR

Up to 5 Gelesis100 and/or placebo capsules 30 minutes before a standard radiolabeled lunch.

Device: Gelesis100; Other: Placebo

B

ACTIVE COMPARATOR

Up to 5 Gelesis100 and/or placebo capsules 30 minutes before a standard radiolabeled lunch.

Device: Gelesis100; Other: Placebo

C

PLACEBO COMPARATOR

Placebo capsules 30 minutes before a standard radiolabeled lunch.

Other: Placebo

D

EXPERIMENTAL

Up to 5 Gelesis100 and/or placebo capsules 30 minutes before a radiolabeled water.

Device: Gelesis100; Other: Placebo

E

EXPERIMENTAL

Up to 5 Gelesis100 and/or placebo capsules 10 minutes before a radiolabeled meal.

Device: Gelesis100; Other: Placebo

Interventions

Gelesis100 DEVICE

Gelesis100 capsules

A; B; D; E

Placebo OTHER

Sucrose (sugar) capsules

A; B; C; D; E

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Weight \& Body mass index (BMI)
• BMI between 27 and 35 kg/m², inclusive.
• Body weight ≥50 kg
• Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions.
• Consent: Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent (signed and dated) obtained before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject.
• General health: Good general health with (in the opinion of the Investigator) no clinically significant and relevant abnormalities of medical history or physical examination.

You may not qualify if:

• Medical History
• Current or recurrent disease that, in the opinion of the physician responsible, could affect the study conduct or laboratory assessments (e.g., hepatic disorders, renal insufficiency, congestive heart failure).
• Current or relevant previous history of serious, severe or unstable physical or psychiatric illness, any medical disorder that may require treatment or make the subject unlikely to fully complete the study, or any condition that presents undue risk from the study medication or procedures.
• A history of current or relevant previous non self-limiting GI disorders.
• A history of gastric bypass or any other gastric surgery.
• Acute diarrhoea or constipation in the 14 days before the assessment visit. Diarrhoea will be defined as the passage of liquid faeces and/or stool frequency greater than 3 times per day. Constipation will be defined as failure to open bowels at least every other day.
• Currently suffering from disease known to impact gastric emptying, e.g., migraine, type 1 and type 2 diabetes.
• As a result of a physical examination or screening investigations, the physician responsible considers the volunteer unfit for the study.
• Medications
• Subject has taken prescribed medication within 14 days prior to the first assessment visit. Subjects will be withdrawn from subsequent study days if they commence taking prescribed medication during the study period.
• Subject has taken over-the-counter (OTC) medication within 48 hr prior to the assessment visits. This includes the use of vitamins and natural or herbal remedies e.g., St John's Wort.
• Subject has taken OTC and/or prescribed Non-Steroidal Anti-Inflammatory Drugs (NSAIDS) daily or regularly within 3 months prior to the first assessment visit. Subjects will be withdrawn from subsequent study days if they commence taking OTC and/or prescribed NSAIDS during the study period.
• Alcohol/Substance Abuse
• Recent history (within the last year) of alcohol or other substance abuse.
• Subject has an average weekly alcohol intake of greater than 21 units. 1 unit is equivalent to one 25 mL single measure of whisky, or a third of a pint of beer or half a standard (175 mL) glass of red wine.

Sponsors & Collaborators

• Gelesis, Inc.: lead
• BDD Pharma Ltd: collaborator

Study Sites (1)

Bio-Images Research Ltd

Glasgow, Scotland, G4 0SF, United Kingdom

Location

MeSH Terms

Conditions

Overweight; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hassan M Heshmati, M.D.

  Gelesis, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2015
• First Posted: July 1, 2015
• Study Start: September 1, 2015
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 23, 2016

Record last verified: 2016-08

Locations

GB (1)