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

NCT ID: NCT03058029

Last Updated: 2020-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-22
• Study Completion Date: 2021-01-15

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

Detailed Description

Multicenter, two-cohort, randomized, double-blind, placebo-controlled, parallel-group, fixed-dose, adaptive (Two Phases).

In the first Phase of the adaptive design, unblinded interim analyses were conducted on 57 subjects and used to adjust the design for the second Phase. The first Phase was completed under protocol Version 1.0. Data used in the unblinded interim analyses of the first Phase will not be included in the second Phase (protocol Version 2.0 and subsequent protocol versions) analyses.

The study will evaluate the safety, tolerability and efficacy of Gelesis200 as a superabsorbent hydrogel for weight loss in treated diabetic subjects, untreated diabetic subjects, and prediabetic subjects (Cohort 1).

The study will evaluate separately the safety, tolerability and efficacy of Gelesis200 for weight loss in normoglycemic subjects (Cohort 2).

Conditions

Overweight; Diabetes; PreDiabetes; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Gelesis200

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

Group Type: EXPERIMENTAL

Gelesis200

Intervention Type: DEVICE

Subject would take Gelesis200 capsules 2 times per day.

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DEVICE

Subject would take placebo capsules 2 times per day.

Interventions

Gelesis200

Subject would take Gelesis200 capsules 2 times per day.

Intervention Type: DEVICE

Placebo

Subject would take placebo capsules 2 times per day.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male or female

2. Age ≥22 years and ≤65 years

3. Ambulatory

4. BMI ≥27 kg/M2 and ≤40 kg/M2

5. Non-diabetic subjects, including:

1. Normoglycemic subjects with FPG <100 mg/dL [<5.6 mmol/L] at both Screening Visits with HbA1c <5.7% (<39 mmol/mol), or

2. 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:

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1. 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

2. 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

6. Ability to follow verbal and written instructions

7. Consent obtained via signed ICF

Exclusion Criteria

1. Pregnancy (or positive serum or urine pregnancy test(s) in females of childbearing potential)

2. 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)

3. History of allergic reaction to CMC, citric acid, sodium stearyl fumarate, maltodextrin, gelatin, or titanium dioxide

4. Participation in a weight loss study within the past six (6) months

5. Administration of GSP2, GSP3, Gelesis100, or Gelesis200 in a previous study

6. Administration of investigational products within one (1) month prior to Screening Visit 1

7. Blood transfusion within three (3) months prior to Screening Visit 1

8. Smoking cessation within six (6) months prior to Screening Visit 1 or considering smoking cessation during the study

9. Anticipated surgical intervention during the study period

10. Known Type 1 Diabetes

11. 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

12. Weight change ≥3% within three (3) months prior to and during the Screening period

13. Supine SBP >160 mm Hg and/or supine DBP >95 mm Hg

14. Angina, coronary bypass, or myocardial infarction within six (6) months prior to Screening Visit 1

15. History of swallowing disorders within six (6) months prior to Screening Visit 1

16. Esophageal anatomic abnormalities (e.g., webs, diverticuli, rings)

17. History of gastric or duodenal ulcer within six (6) months prior to Screening Visit 1

18. History of gastroparesis (e.g., chronic nausea, vomiting ≥2 occurrences per week, heartburn, etc.) within six (6) months prior to Screening Visit 1

19. History of gastric bypass or any other gastric surgery

20. History of inflammatory bowel diseases

21. History of intestinal stricture (e.g., Crohn's disease)

22. History of intestinal obstruction or high risk of intestinal obstruction, including suspected small bowel adhesions

23. History of pancreatitis within six (6) months prior to Screening Visit 1

24. History of malabsorption within six (6) months prior to Screening Visit 1

25. Laxative users, except those on stable doses within one (1) month prior to Screening Visit 1

26. History of hepatitis B or C within six (6) months prior to Screening Visit 1

27. History of HIV

28. History of cancer within the past five (5) years (except adequately-treated localized basal cell skin cancer or in situ uterine cervical cancer)

29. Any other clinically significant disease interfering with the assessments of Gelesis200 (e.g., disease requiring corrective treatment, potentially leading to study discontinuation)

30. Abnormal serum TSH

31. HbA1c >8.5% (>69 mmol/mol)

32. Serum LDL cholesterol ≥160 mg/dL (≥4.15 mmol/L)

33. Serum triglycerides ≥350 mg/dL (≥3.96 mmol/L)

34. Positive test for drugs of abuse in the urine

35. Any relevant biochemical abnormality interfering with the assessments of Gelesis200

36. Anti-obesity medications (including herbal preparations) within one (1) month prior to Screening Visit 1

37. Systemic corticosteroids within one (1) month prior to Screening Visit 1

38. Thyroid hormones or preparations within one (1) month prior to Screening Visit 1 [except stable dose of replacement therapy for at least two (2) months]

39. TSH suppression therapy for thyroid cancer

40. Estrogen within one (1) month prior to Screening Visit 1 [except stable dose of replacement therapy or contraceptives for at least one (1) month]

41. Any other medication known to cause weight loss or weight gain within one (1) month prior to Screening Visit 1

42. Antidiabetic medications within one (1) month prior to Screening Visit 1 [except stable doses of metformin and DPP-4 inhibitors for at least one (1) month in subjects with Type 2 Diabetes]

43. Change in medications treating hypertension within one (1) month [one (1) week for diuretics] prior to Screening Visit 1

44. Change in medications treating dyslipidemia within one (1) month prior to Screening Visit 1

45. Anticipated requirement for use of prohibited concomitant medications

46. Any other condition that, in the opinion of the Investigator or Sponsor, would interfere with the subject's ability to participate in the study

• Minimum Eligible Age: 22 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Gelesis, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Central Alabama Research

Birmingham, Alabama, United States

Meridien Research, Inc - Bradenton

Bradenton, Florida, United States

Baptist Diabetes Associates, P.A.

Miami, Florida, United States

Metabolic Research Institute, Inc.

West Palm Beach, Florida, United States

The Center for Pharmaceutical Research

Kansas City, Kansas, United States

Clinical Research Center of Nevada

Las Vegas, Nevada, United States

Radiant Research

Cincinnati, Ohio, United States

Mountain View Clinical Research - Greer

Greer, South Carolina, United States

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

Knoxville, Tennessee, United States

SAMCRC

San Antonio, Texas, United States

Tarheel Clinical Research, LLC

Sugar Land, Texas, United States

Rainier Clinical Research Center

Renton, Washington, United States

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

Ottawa, Ontario, Canada

Université Laval

Québec, Quebec, Canada

Health&Care, s.r.o

Prague, , Czechia

University of Copenhagen - Department of Nutrition, Exercise and Sports

Frederiksberg, , Denmark

Qualiclinic Kft

Budapest, , Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, , Hungary

Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz

Gyula, , Hungary

IRCCS Policlinico San Donato

San Donato Milanese, , Italy

NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny

Bialystok, , Poland

NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek

Lodz, , Poland

MEDICOME Sp. z o.o.

Oświęcim, , Poland

Centrum Zdrowia Metabolicznego Pawel Bogdanski

Poznan, , Poland

Centrum Badawcze Wspolczesnej Terapii

Warsaw, , Poland

Oakenhurst Medical Practice

Blackburn, , United Kingdom

Ashgate Medical Practice (Research Office)

Chesterfield, , United Kingdom

Aintree University Hospital

Liverpool, , United Kingdom

The James Cook University Hospital

Middlesbrough, , United Kingdom

Morriston Hospital

Swansea, , United Kingdom

Countries

United States; Canada; Czechia; Denmark; Hungary; Italy; Poland; United Kingdom

Related Links

http://www.gelesis.com/pipeline/

Gelesis Website

Other Identifiers

GS-200-002

Identifier Type: -

Identifier Source: org_study_id