Effectiveness and safety of LM011 in treating subjects diagnosed with non-alcoholic steatohepatitis (NASH).

Phase 2

Recruiting

• Conditions: on-Alcoholic Steatohepatitis (NASH); Non-Alcoholic Steatohepatitis (NASH); Metabolic and Endocrine - Metabolic disorders; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

• Registration Number: ACTRN12619000610134
• Lead Sponsor: ifemax Laboratories (Australia) Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-04-23
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

1.Males or females between 18 and 75 years old with a documented diagnosis of NASH by a licensed medical practitioner within the last 12 months prior to Screening Visit
2.BMI between 28 and 40 kg/m2
3.Negative urine drugs-of-abuse screen
4.MRI-PDFF at least 15.7%
5.Fibroscan score not more than 12 kPa
6.Able and willing to comply with the protocol and availability for all scheduled clinic visits and telephone calls

Exclusion Criteria

1.Known cardiovascular disease
2.History of cirrhosis based on imaging or clinical criteria and/or hepatic decompensation including ascites, hepatic encephalopathy or variceal bleeding.
3.History of liver transplantation
4.History of hepatocellular carcinoma (HCC)
5.History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous carcinoma at the time of Screening visit
6.Females who are pregnant or breastfeeding.
7.Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents (such as systemic corticosteroids, interleukins, interferons).
8.Use of any experimental medications within the last 6 months of Screening Visit or during participation of the trial.
9.Weight loss of >5% from the time of diagnosis of NASH, based on subject’s reporting
10.Currently or participated in a weight loss program within the last 6 months.
11.Any history of bariatric surgery.
12.Diabetes mellitus Type I
13.Daily alcohol intake (on average) >20 ml (2 units)/day for women and 30 ml (3 units)/day for men within the last 12 months prior to Screening Visit and plan to consume the same alcohol amount referenced above during the trial.
14.Any severe, acute, or chronic medical or psychiatric condition that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the investigator’s opinion, would make the subject inappropriate for entry into this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified