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Status:

UNKNOWN

Study on GS300 on NAFLD

Lead Sponsor:

Gelesis, Inc.

Conditions:

Nonalcoholic Fatty Liver

Weight Loss

Eligibility:

All Genders

22-65 years

Phase:

NA

Brief Summary

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

Detailed Description

This is a multicenter, randomized, placebo-controlled, double-blinded, parallel-group study. Patients will be randomized 1:1 to receive either GS300 or placebo. The study includes an up to 6 weeks scr...

Eligibility Criteria

Inclusion

  • 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

Exclusion

  • 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
  • Hemochromatosis
  • Drug-induced liver disease, as defined on the basis of typical exposure and history
  • Bile duct obstruction
  • Suspected or proven liver cancer
  • History of hepatic encephalopathy
  • Portal hypertension (esophageal varices, ascites, splenomegaly)
  • History of gastric surgery (up to 10% patients with history of gastric bypass or sleeve gastrectomy may be enrolled if the surgery occurred more than 6 months prior to enrollment and patients had a weight change \< 5% during the 3 months prior to enrollment)
  • Angina, coronary bypass, or myocardial infarction within 6 months prior to Screening Visit
  • Inflammatory bowel disease, celiac disease, or other significant gastrointestinal disease - for example, a history of bowel obstruction without surgical correction (patients with irritable bowel syndrome may be enrolled)
  • Pregnancy
  • Absence of medically approved contraceptive methods in females of childbearing potential (e.g., hysterectomy, oral contraceptives, non-oral contraceptive medications or intrauterine device combined with a barrier method, two combined barrier methods such as diaphragm and condom or spermicide, or condom and spermicide; bilateral tubal ligation and vasectomy are not acceptable methods)
  • Type 1 Diabetes
  • HbA1c \> 8.5% (\> 69 mmol/mol)
  • Serum LDL-C ≥ 160 mg/dL (≥ 4.15 mmol/L)
  • Serum triglycerides ≥ 350 mg/dL (≥ 3.96 mmol/L)
  • Use of any medications for the treatment of diabetes within 3 months prior to enrollment. Note, metformin, DPP-4 inhibitors, and insulin at a stable dose over the last 3 months are allowed. Insulin dose variance of 20% (decrease or increase) is allowed.
  • Any change in standard of care or background therapy for liver disease or other ongoing chronic conditions within 3 months prior to enrollment, including changes in the following:
  • Antidiabetic medications (metformin, DPP-4 inhibitors, insulin)
  • Thyroid hormones
  • Medications treating depression
  • Medications treating dyslipidemia
  • Medications treating hypertension
  • Vitamin E
  • Regular/daily use of any of the following within 3 months prior to enrollment or anticipated regular/daily use during the study period:
  • High dose nonsteroidal anti-inflammatory drugs (NSAIDS) (equivalent of \> 3,200 mg/day ibuprofen)
  • Systemic corticosteroids, anabolic steroids
  • Methotrexate, amiodarone, tamoxifen, tetracyclines, estrogens at doses greater than those used for hormone replacement, valproic acid
  • Probiotic supplements (yogurt is allowed)
  • Addictive, non-prescribed medications including amphetamines, barbiturates, cocaine, opiates, methadone and phencyclidine as per medical history or regular daily use of cannabinoids
  • Use of any anti-obesity medications (including herbal preparations) within 2 months prior to enrollment or any anticipated use during the study period
  • History of allergic reaction to carboxymethylcellulose (CMC), citric acid, sodium stearyl fumarate, raw cane sugar, gelatin, or titanium dioxide
  • Currently enrolled in another investigational device or drug study, or less than 3 months since ending another investigational device or drug study(s), or receiving other investigational treatment(s)
  • Any disease or condition that, in the opinion of the investigator or Sponsor, would interfere with study participation

Key Trial Info

Start Date :

July 1 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2023

Estimated Enrollment :

250 Patients enrolled

Trial Details

Trial ID

NCT04887766

Start Date

July 1 2022

End Date

December 31 2023

Last Update

January 24 2022

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