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Clinical Trials/NL-OMON44568
NL-OMON44568CompletedPhase 2

A 12-week randomized, patient and investigator blinded, placebo-controlled, parallel group study to investigate the efficacy of LIK066 in obese patients with non-alcoholic steatohepatitis (NASH) - Efficacy of LIK066 for the treatment of non-alcoholic steatohepatitis

ovartis0 sites8 target enrollmentStarted: TBDLast updated:
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Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Sponsor
ovartis
Enrollment
8
Study OverviewEligibility CriteriaInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

No summary available.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18 to 99 (—)

Inclusion Criteria

  • •Presence of NASH as demonstrated by one of the following:
  • •Histologic confirmed NASH based on liver biopsy obtained 2 years or less before randomization with a fibrosis level of F1, F2 or F3, in the absence of a histological diagnosis of alternative chronic liver diseases AND ALT * 50 IU/L (males) or * 35 IU/L (females) at screening;Or
  • •Phenotypic diagnosis of NASH based on presence of all three of the following at screening:
  • •- ALT * 50 IU/L (males) or * 35 IU/L (females) AND
  • •- BMI * 27 kg/m2 (in patients with a self-identified race other than Asian) or *23 kg/m2 (in patients with a self-identified Asian race) AND
  • •- Diagnosis of Type 2 diabetes mellitus by HbA1C: * 6.5% and * 10%

Exclusion Criteria

  • •- Use of GLP-1 agonists such as liraglutide, exenatide, lixisenatide, albiglutide or dulaglutide; SGLT-2 inhibitors such as canagliflozin, empagliflozin or dapagliflozin; Thiazolidinediones (TZDs) such as pioglitazone; FXR agonists such as obeticholic acid (OCA) and any pharmacologically active weight-loss medications such as lorcaserin prior to 6 weeks of screening visit and up to end of study visit
  • •- eGFR * 45ml/min/1.73m2 based on MDRD equation
  • •- Patients on treatment with the following medicines unless they are on a constant dose for *3 months before randomization: anti-diabetic medications, insulin (if *25% change in dose),
  • •beta-blockers, thiazide diuretics, fibrates, statins, niacin, ezetimibe, vitamin E (if doses > 400 IU/day; doses > 800 IU/day are prohibited), thyroid hormone, psychotropic medications, estrogen or estrogen containing birth control
  • •- Current or history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to screening (significant alcohol consumption is defined as more
  • •than 20 g/day in females and more than 30 g/day in males, on average)
  • •- Presence of cirrhosis on liver biopsy or clinical diagnosis of cirrhosis
  • •- Type I diabetes and uncontrolled diabetes defined as HbAlc > 10 % within 60 days prior to enrollment
  • •- Patients with contraindications to MRI imaging
  • •- For those patients that have had a previous liver biopsy:
  • •Significant weight loss (>15%) or change in clinical status (in the opinion of the investigator) since the diagnostic liver biopsy to screening
  • •- History or presence of other concomitant liver diseases
  • •- Clinical evidence of hepatic decompensation or severe liver impairment
  • •- History of drug or alcohol abuse within the 12 months prior to dosing, or evidence of such abuse as indicated by the laboratory assays conducted during screening and baseline
  • •- History of inflammatory bowel disease
  • •- History or current diagnosis of ECG abnormalities indicating significant risk of safety for patients participating in the study
  • •- History of ketoacidosis, lactic acidosis, or hyperosmolar coma OR if occurring between Screening Visit and Randomization Visit.
  • •- History of lower limb amputation (including toe amputation) OR if occurring between Screening Visit and Randomization Visit.

Investigators

Sponsor
ovartis

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