Effect of Gelesis200 on Body Weight in Overweight and Obese Subjects w/o Type 2 Diabetes

NCT03058029 | Unknown FDA Device

• 1 other identifier: GS-200-002
• Study Type: interventional
• Target: 300
• Locations: 8 countries
• Sites: 30

Brief Summary

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Assessing the Effect of Gelesis200 on Body Weight in Overweight and Obese Subjects without or with Type 2 Diabetes

Conditions

Overweight; Diabetes; PreDiabetes; Obesity

Outcome Measures

Primary Outcomes (2)

• Proportion of subjects with weight loss ≥5.0%

  In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1)

  Change from baseline to day 171 (week 25)

• Percent change in body weight

  In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1)

  Change from baseline to day 171 (week 25)

Secondary Outcomes (8)

• Proportion of subjects with weight loss ≥10.0%

  Up to 25 weeks

• Proportion of subjects with weight loss ≥10.0%

  Up to 25 weeks

• Proportion of subjects with weight loss ≥10.0%

  Up to 25 weeks

• Proportion of subjects with weight loss ≥5.0%

  Up to 25 weeks

• Proportion of subjects with weight loss ≥5.0%

  Up to 25 weeks

Other Outcomes (18)

• Proportion of subjects with weight loss ≥7.5%

  Change from baseline to day 171 (week 25)

• Proportion of subjects with weight loss ≥7.5%

  Change from baseline to day 171 (week 25)

• Proportion of subjects with weight loss ≥7.5%

  Change from baseline to day 171 (week 25)

Study Arms (2)

Gelesis200

EXPERIMENTAL

Gelesis200: Three (3) Gelesis200 capsules (2.10 gram (g)) two (2) times per day (id est (i.e.), lunch and dinner)

Device: Gelesis200

Placebo

PLACEBO COMPARATOR

Placebo: Three (3) placebo capsules two (2) times per day (i.e., lunch and dinner)

Device: Placebo

Interventions

Gelesis200 DEVICE

Subject would take Gelesis200 capsules 2 times per day.

Gelesis200

Placebo DEVICE

Subject would take placebo capsules 2 times per day.

Placebo

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female
• Age ≥22 years and ≤65 years
• Ambulatory
• BMI ≥27 kg/M2 and ≤40 kg/M2
• Non-diabetic subjects, including:
• Normoglycemic subjects with FPG \<100 mg/dL \[\<5.6 mmol/L\] at both Screening Visits with HbA1c \<5.7% (\<39 mmol/mol), or
• Prediabetic subjects with FPG ≥100 mg/dL and \<126 mg/dL (≥5.6 mmol/L and ≤7.0 mmol/L) at both Screening Visits with HbA1c ≤6.4% (≤46 mmol/mol) \[if only one (1) value is within this range, the other value should not be ≥126 mg/dL (≥7.0 mmol/L) and HbA1c should be ≥5.7% (≥39 mmol/mol) and ≤6.4% (≤46 mmol/mol)\]; or Diabetic subjects, including:
• <!-- -->
• Untreated subjects with FPG ≤200 mg/dL (≤11.2 mmol/L) at both Screening Visits and either FPG ≥126 mg/dL (≥7.0 mmol/L) at both Screening Visits or FPG \<126 mg/dL (\<7.0 mmol/L) at one (1) or both Screening Visits with HbA1c ≥6.5% (≥48 mmol/mol), or
• Drug-treated subjects with metformin and/or DPP-4 inhibitors with FPG ≥70 mg/dL and ≤270 mg/dL (≥3.9 mmol/L and ≤15.1 mmol/L) at both Screening Visits
• Ability to follow verbal and written instructions
• Consent obtained via signed ICF

You may not qualify if:

• Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential)
• Absence of medically approved contraception in females of childbearing potential (e.g., hysterectomy, oral contraceptive medications, intrauterine device combined with a barrier method, two (2) combined barrier methods such as diaphragm and condom or spermicide, or condom and spermicide; bilateral tubal ligation and vasectomy are acceptable contraceptive methods when combined with a single method above)
• History of allergic reaction to CMC, citric acid, sodium stearyl fumarate, maltodextrin, gelatin, or titanium dioxide
• Participation in a weight loss study within the past six (6) months
• Administration of GSP2, GSP3, Gelesis100, or Gelesis200 in a previous study
• Administration of investigational products within one (1) month prior to Screening Visit 1
• Blood transfusion within three (3) months prior to Screening Visit 1
• Smoking cessation within six (6) months prior to Screening Visit 1 or considering smoking cessation during the study
• Anticipated surgical intervention during the study period
• Known Type 1 Diabetes
• History of eating disorders including binge eating (except mild binge eating) or emesis ≥2/week from any cause within six (6) months prior to Screening Visit 1
• Weight change ≥3% within three (3) months prior to and during the Screening period
• Supine SBP \>160 mm Hg and/or supine DBP \>95 mm Hg
• Angina, coronary bypass, or myocardial infarction within six (6) months prior to Screening Visit 1
• History of swallowing disorders within six (6) months prior to Screening Visit 1

Sponsors & Collaborators

• Gelesis, Inc.: lead

Study Sites (30)

Central Alabama Research

Birmingham, Alabama, 35209, United States

Location

Meridien Research, Inc - Bradenton

Bradenton, Florida, 34201, United States

Location

Baptist Diabetes Associates, P.A.

Miami, Florida, 33156, United States

Location

Metabolic Research Institute, Inc.

West Palm Beach, Florida, 33401, United States

Location

The Center for Pharmaceutical Research

Kansas City, Kansas, 64114, United States

Location

Clinical Research Center of Nevada

Las Vegas, Nevada, 89104, United States

Location

Radiant Research

Cincinnati, Ohio, 45236, United States

Location

Mountain View Clinical Research - Greer

Greer, South Carolina, 29651, United States

Location

Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville

Knoxville, Tennessee, 37920, United States

Location

SAMCRC

San Antonio, Texas, 78229, United States

Location

Tarheel Clinical Research, LLC

Sugar Land, Texas, 77478, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

University of Ottawa - Institut de Recherche de l'Hospital d'Ottawa (IRHO) (Ottawa Hospital Research Institute (OHRI))

Ottawa, Ontario, K1N 6N5, Canada

Location

Université Laval

Québec, Quebec, G1V 0A6, Canada

Location

Health&Care, s.r.o

Prague, 182 00, Czechia

Location

University of Copenhagen - Department of Nutrition, Exercise and Sports

Frederiksberg, 1958, Denmark

Location

Qualiclinic Kft

Budapest, 1036, Hungary

Location

Debreceni Egyetem Klinikai Kozpont

Debrecen, H-4032, Hungary

Location

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, 5701, Hungary

Location

IRCCS Policlinico San Donato

San Donato Milanese, 20097, Italy

Location

NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny

Bialystok, 15-435, Poland

Location

NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek

Lodz, 94-048, Poland

Location

MEDICOME Sp. z o.o.

Oświęcim, 32-600, Poland

Location

Centrum Zdrowia Metabolicznego Pawel Bogdanski

Poznan, 60-589, Poland

Location

Centrum Badawcze Wspolczesnej Terapii

Warsaw, 02-679, Poland

Location

Oakenhurst Medical Practice

Blackburn, BB21AX, United Kingdom

Location

Ashgate Medical Practice (Research Office)

Chesterfield, v, United Kingdom

Location

Aintree University Hospital

Liverpool, L9 7AL, United Kingdom

Location

The James Cook University Hospital

Middlesbrough, TS4 3 BW, United Kingdom

Location

Morriston Hospital

Swansea, SA6 6NL, United Kingdom

Location

Related Links

• Gelesis Website

MeSH Terms

Conditions

Overweight; Diabetes Mellitus; Prediabetic State; Obesity

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants are assigned to one of two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: January 13, 2017
• First Posted: February 20, 2017
• Study Start: February 22, 2017
• Primary Completion: January 15, 2021
• Study Completion: January 15, 2021
• Last Updated: July 21, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); HU (3); US (12); PL (5); DK (1); CA (2); CZ (1); GB (5)