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A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)

An Open-Label Multi-Center Study to Assess the Safety and Potential of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)

NCT04616014•Oramed, Ltd.

View on ClinicalTrials.gov

Summary

A Study to Assess the Safety and Potential of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients with Nonalcoholic Steatohepatitis (NASH)

Detailed Description

An Open-Label Multi-Center Study to Assess the Safety and Potential of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients with Nonalcoholic Steatohepatitis (NASH)

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Male or female aged 18-70 years.
•BMI ≥25.
•Known type 2 DM according to American Diabetic Association (one of the three needed): Fasting Plasma Glucose ≥126 mg/dl or 2h postprandial (PG) following 75g OGTT ≥200 mg/dl or HbA1c \> 6.5%28 or on treatment with at least one and no more than three of the following oral anti-diabetic medications, metformin, sulfonylurea, DPP-4 inhibitors, oral GLP-1 receptor agonists (semaglutide), SGLT-2 inhibitor, or Thiazolidinediones (TZDs).
•Diagnosis of NAFLD by non-invasive determination of hepatic steatosis grade S1, defined as hepatic steatosis\>8%. by MRI- PDFF and CAP FibroScan ≥ 238 dB/m.
•Liver enzyme abnormalities: ULN≤5 times.
•Fibrosis score 21≤F≤3 as defined by FibroScan measurement (Liver stiffness measurement, LSM) of 6 ≤ LSM ≤ 12 kPa.
•Signature of the written informed consent.
•Negative urineserum pregnancy test at Screening study entry for women of childbearing potential (WCBP).
•Females must have a negative urine pregnancy test result at screening, prior to the start of the run-in period, at initiation of active dosing and every 4 weeks till the end of the study. A negative urine and serum pregnancy test must be obtained prior to active dosing. Males and females of childbearing potential must use two methods of contraception, one of which must be a highly effective method from the time of screening to the last dosing study visit (22 weeks).
•Highly effective methods include:
+13 more criteria

Exclusion Criteria

•Patients with active (acute or chronic) liver disease other than NASH (e.g. viral hepatitis, genetic hemochromatosis, Wilson disease, alpha-1 antitrypsin deficiency, alcohol liver disease, drug induced liver disease) at the time of enrolment.
•ALT or AST \> 5 times ULN.
•Abnormal synthetic liver function (serum albumin ≤3.5gm%, INR \>1.3).
•Known alcohol and/or any other drug abuse or dependence in the last five years.
•Weight \>120 Kg (264.6 lbs.).
•Known history or presence of clinically significant, cardiovascular, gastrointestinal, metabolic (other than diabetes mellitus), neurologic, pulmonary, endocrine, psychiatric, neoplastic disorder or nephrotic syndrome.
•History or presence of any disease or condition known to interfere with the absorption, distribution, metabolism or excretion of drugs including bile salt metabolites (e.g. inflammatory bowel disease (IBD), previous intestinal (ileal or colonic) operation, chronic pancreatitis, celiac disease or previous vagotomy.
•Weight loss of more than 5% within 6 months prior to enrolment.
•History of bariatric surgery.
•Uncontrolled blood pressure BP ≥150/≥95.
+17 more criteria

Locations (1)

Universitaire Ziekenhuis Gent

Ghent, Belgium

Key Dates

Start Date

March 1, 2021

Primary Completion Date

July 1, 2022

Completion Date

September 15, 2022

Last Updated

March 29, 2024

Enrollment

ACTUAL participants

Conditions

Nonalcoholic Steatohepatitis (NASH)

Interventions

ORMD-0801 QD

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 29, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Oral Insulin to Reduce Liver Fat Content in Type 2 Diabetes Patients With Nonalcoholic Steatohepatitis (NASH)

Inclusion Criteria

Exclusion Criteria

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