Study on GS300 on NAFLD

NCT04887766 | Unknown DMC

• 1 other identifier: GS-300-001
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

To determine the efficacy of GS300 when administered for 24 weeks in patients with Nonalcoholic Fatty Liver Disease (NAFLD).

Conditions

Nonalcoholic Fatty Liver; Weight Loss

Outcome Measures

Primary Outcomes (3)

• Weight loss ≥ 5%

  Proportion of patients with weight loss ≥ 5% at Week 24.

  24 Weeks

• Placebo-adjusted percent change in weight from Baseline to Week 24

  Placebo-adjusted percent change in weight from Baseline to Week 24.

  24 Weeks

• Relative reduction in liver fat

  Relative reduction in liver fat from Baseline to Week 24, as measured by hepatic Magnetic Resonance Imaging Proton Density Fat Fraction (MRI PDFF).

  24 Weeks

Secondary Outcomes (6)

• Weight loss ≥ 7.5%

  24 Weeks

• Weight loss ≥ 10%

  24 Weeks

• To evaluate the percentage of patients with ≥ 30% relative reduction in liver fat

  24 Weeks

• To assess placebo-adjusted waist circumference reduction

  24 Weeks

• To assess the impact of GS300 on glycemic control in patients with NAFLD

  24 Weeks

Other Outcomes (3)

• Intestinal Permeability

  24 Weeks

• Vitamin Levels

  24 Weeks

• Gut Peptides

  24 Weeks

Study Arms (2)

Active

ACTIVE COMPARATOR

GS300: Three (3) GS300 capsules \[approximately 0.65 grams (g)\] two (2) times per day ingested 10 minutes (min) before meals (i.e., lunch and dinner) - total of 3.9 g per day

Device: GS300

Placebo

PLACEBO COMPARATOR

Placebo: Three (3) placebo capsules two (2) times per day 10 min before meals (i.e., lunch and dinner)

Device: Placebo

Interventions

GS300 DEVICE

Gelesis300 hydrogel in gelatin capsules

Active

Placebo DEVICE

Placebo capsules

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:

• Age ≥ 22 years and ≤ 65 years
• Body Mass Index (BMI) ≥ 27 and ≤ 40 kilogram (kg)/meter2 (m2)
• Negative for Hepatitis B, C and Human Immunodeficiency Virus (HIV) within 6 months of screening \[HbsAg negative and Hepatitis C Virus (HCV) RNA negative; subjects treated and cured of HCV must have completed treatment and tested negative for HCV at least 2 years prior to study enrollment\]
• Fibroscan CAP score \> 300 decibels (dB)/m
• Stable body weight defined as less than 5% change in body weight in the 3 months prior to screening (per patient report)
• Approximately 250 patients (approximately 125 patients per treatment arm)
• Prediabetes i) Untreated prediabetic patients with FPG ≥ 100 mg/ dL (≥ 5.6 mmol/L) and \< 126 mg/dL (\< 7.0 mmol/L) at both Screening Visits with HbA1c ≤ 6.4% (≤ 46 mmol/mol) - if only one 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) ii) Drug-treated (metformin) prediabetic patients with FPG ≥ 70 mg/dL (≥ 3.9 mmol/L) and \< 126 mg/dL (\< 7.0 mmol/L) at both Screening Visits
• Type 2 Diabetes i) Untreated type 2 diabetic patients 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 or both Screening Visits with HbA1c ≥ 6.5% (≥ 48 mmol/mol) ii) Drug-treated \[metformin and/or dipeptidyl peptidase-4 (DPP-4) inhibitors, and/or insulin\] type 2 diabetic patients with FPG ≥ 70 mg/dL (≥ 3.9 mmol/L) and ≤ 270 mg/dL (≤ 15.1 mmol/L) at both Screening Visits Note, approximately 10% to 20% of enrolled Type 2 diabetic patients will be on insulin therapy
• Normoglycemia (up to approximately 10% of patients) Normoglycemic patients with FPG ≥ 70 mg/dL (≥ 3.9 mmol/L) and \< 100 mg/ dL (\< 5.6 mmol/L) at both Screening Visits with HbA1c \< 5.7% (\< 39 mmol/mol) and HOMA-IR ≥ 3.0
• MRI PDFF ≥ 10%
• Willing to sign the ICF prior to any study related procedures

You may not qualify if:

• Self-reported alcohol intake \> 20 gram (g)/day for women and \> 30 g/day for men (on average per day) as per medical history
• Alcohol Use Disorders Identification Test (AUDIT) questionnaire: AUDIT-C score of ≥ 4 in men and ≥ 3 in women will be followed by a full AUDIT questionnaire by interview with patients excluded for score ≥ 8
• Prior liver transplant
• Liver cirrhosis as evidenced by any of the following:
• Serum albumin \< 3.5 g/dL (0.53 mmol/L)
• INR \> 1.3 (unless due to anticoagulant therapy)
• AST/ALT ratio ≥ 2
• Direct bilirubin \> 0.3 mg/dL (5.13 micromol (micromol)/L)
• Platelet count \< 150,000/microL
• History or evidence of other chronic liver diseases, including, but not limited to the following:
• Current active autoimmune hepatitis
• Primary biliary cholangitis (PBC)
• Primary sclerosing cholangitis
• Wilson's disease
• Alpha-1-antitrypsin (A1AT) deficiency

Sponsors & Collaborators

• Gelesis, Inc.: lead

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Weight Loss

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Hassan M Heshmati, MD

  Gelesis, Inc.

  STUDY DIRECTOR

Central Study Contacts

Valerie Colletta

CONTACT

1-857-201-5330; vcolletta@gelesis.com

Henry Calderon

CONTACT

1-857-201-5330; hcalderon@gelesis.com

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: May 11, 2021
• First Posted: May 14, 2021
• Study Start: July 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: January 24, 2022

Record last verified: 2022-01