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

Obesity Clinical Trial

— LIGHT-UP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03058029
• Other study ID #: GS-200-002
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 22, 2017
• Est. completion date: January 15, 2021

Study information

• Verified date: July 2020
• Source: Gelesis, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years to 65 Years

Eligibility

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:

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

Related Conditions & MeSH terms

• Body Weight
• Diabetes
• Diabetes Mellitus
• Obesity
• Overweight
• PreDiabetes
• Prediabetic State

Intervention

Device:
• Gelesis200
Subject would take Gelesis200 capsules 2 times per day.
• Placebo
Subject would take placebo capsules 2 times per day.

Locations

Country	Name	City	State
Canada	University of Ottawa - Institut de Recherche de l'Hospital d'Ottawa (IRHO) (Ottawa Hospital Research Institute (OHRI))	Ottawa	Ontario
Canada	Université Laval	Quebec City	Quebec
Czechia	Health&Care, s.r.o	Prague
Denmark	University of Copenhagen - Department of Nutrition, Exercise and Sports	Frederiksberg
Hungary	Qualiclinic Kft	Budapest
Hungary	Debreceni Egyetem Klinikai Kozpont	Debrecen
Hungary	Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaz	Gyula
Italy	IRCCS Policlinico San Donato	San Donato Milanese
Poland	NZOZ Specjalistyczny Osrodek Internistyczno - Diabetologiczny	Bialystok
Poland	NZOZ All - Med Centrum Medyczne Specjalistyczne Gabinety Lekarskie Marcin Ogorek	Lodz
Poland	MEDICOME Sp. z o.o.	Oswiecim
Poland	Centrum Zdrowia Metabolicznego Pawel Bogdanski	Poznan
Poland	Centrum Badawcze Wspolczesnej Terapii	Warszawa
United Kingdom	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 States	Central Alabama Research	Birmingham	Alabama
United States	Meridien Research, Inc - Bradenton	Bradenton	Florida
United States	Radiant Research	Cincinnati	Ohio
United States	Mountain View Clinical Research - Greer	Greer	South Carolina
United States	The Center for Pharmaceutical Research	Kansas City	Kansas
United States	Volunteer Research Group and New Orleans Center for Clinical Research - Knoxville	Knoxville	Tennessee
United States	Clinical Research Center of Nevada	Las Vegas	Nevada
United States	Baptist Diabetes Associates, P.A.	Miami	Florida
United States	Rainier Clinical Research Center	Renton	Washington
United States	SAMCRC	San Antonio	Texas
United States	Tarheel Clinical Research, LLC	Sugar Land	Texas
United States	Metabolic Research Institute, Inc.	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gelesis, Inc.

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of subjects with weight loss =7.5%	In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1)	Change from baseline to day 171 (week 25)
Other	Proportion of subjects with weight loss =7.5%	In treated diabetic subjects (subgroup of Cohort 1)	Change from baseline to day 171 (week 25)
Other	Proportion of subjects with weight loss =7.5%	Pre-diabetics and untreated diabetics (subgroup of Cohort 1)	Change from baseline to day 171 (week 25)
Other	Percent change in body weight	In treated diabetic subjects (subgroup of Cohort 1)	Change from baseline to day 171 (week 25)
Other	Percent change in body weight	Pre-diabetics and untreated diabetics (subgroup of Cohort 1)	Change from baseline to day 171 (week 25)
Other	Change in waist circumference	In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1)	Change from baseline to day 171 (week 25)
Other	Percent change in estimated excess body weight	In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1)	Change from baseline to day 171 (week 25)
Other	Change in BMI	In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1)	Change from baseline to day 171 (week 25)
Other	Percent change in FSI	In subjects FSI =10 µU/mL in both screening visits (subgroup of Cohort 1)	Change from baseline to day 171 (week 25)
Other	Percent change in HOMA-IR and log HOMA-IR	Pre-diabetics and untreated diabetics (subgroup of Cohort 1)	Change from baseline to day 171 (week 25)
Other	Percent change in QUICKI	Pre-diabetics and untreated diabetics (subgroup of Cohort 1)	Change from baseline to day 171 (week 25)
Other	Percent change in fasting serum lipids	Subjects with dyslipidemia defined as LDL =130 mg/dL (=3.37 mmol/L) and/or triglycerides =150 mg/dL (=1.69 mmol/L)] at baseline (subgroup of Cohort 1)	Change from baseline to day 171 (week 25)
Other	Change in blood pressure	Subjects with hypertension defined as SBP =140 mm Hg and/or DBP =90 mm Hg) at baseline (subgroup of Cohort 1)	Change from baseline to day 171 (week 25)
Other	Proportion of subjects with weight loss =5.0%	Normoglycemic subjects (Cohort 2)	Change from baseline to day 171 (week 25)
Other	Percent change in body weight	Normoglycemic subjects (Cohort 2)	Change from baseline to day 171 (week 25)
Other	Percent change in FSI	Subjects with FSI =10 µU/mL at both Screening Visits (subgroup of Cohort 2)	Change from baseline to day 171 (week 25)
Other	Percent change in insulin AUC during OGTT	Subjects with FSI =10 µU/mL at both Screening Visits (subgroup of Cohort 2)	Change from baseline to day 171 (week 25)
Other	Proportion of subjects with weight loss =7.5%	Normoglycemic subjects (Cohort 2)	Change from baseline to day 171 (week 25)
Primary	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)
Primary	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	Proportion of subjects with weight loss =10.0%	In treated diabetic subjects, untreated diabetic subjects, and pre-diabetic subjects (Cohort 1)	Up to 25 weeks
Secondary	Proportion of subjects with weight loss =10.0%	Treated diabetics (subgroup of Cohort 1)	Up to 25 weeks
Secondary	Proportion of subjects with weight loss =10.0%	Pre-diabetics and untreated diabetics (subgroup of Cohort 1)	Up to 25 weeks
Secondary	Proportion of subjects with weight loss =5.0%	Treated diabetic subjects (subgroup of Cohort 1)	Up to 25 weeks
Secondary	Proportion of subjects with weight loss =5.0%	Pre-diabetics and untreated diabetics (subgroup of Cohort 1)	Up to 25 weeks
Secondary	Percent change in FSI	Pre-diabetics and untreated diabetics (subgroup of Cohort 1)	Up to 25 weeks
Secondary	Percent change in insulin AUC during OGTT	Pre-diabetic subjects (subgroup of Cohort 1)	Up to 25 weeks
Secondary	Change in HbA1c	Diabetic subjects with HbA1c =7.5% (=58 mmol/mol) at baseline (subgroup of Cohort 1)	Up to 25 weeks

External Links

•   Gelesis Website