Companion Protocol for ¹³C-Methacetin Breath Tests in BMS: NCT03486899, NCT03486912 Referenced Trials

Meridian Bioscience

Status: Completed

Conditions: NASH - Nonalcoholic Steatohepatitis

Treatments: Device: BreathID MCS device; Drug: BMS-986036; Combination Product: ¹³C-Methacetin Breath Test

Study type: Interventional

Funder types: Industry

Identifiers

NCT03611101

BMS-EX-0118

Details and patient eligibility

About

This is a companion study assessing the ¹³C-Methacetin Breath Test (MBT) in subjects participating in the Bristol Myers-Squibb (BMS) NCT03486899 and NCT03486912 referenced studies using study drug BMS-986036.

Full description

Subjects that are enrolled into either of two separate BMS sponsored IND (Investigational New Drug) studies (referenced by NCT03486899 and NCT03486912) at selected study sites will be offered the opportunity to perform the MBT. These will be considered as two separate study cohorts (cohort 1 and 2 respectively) within this companion protocol. There are four (4) treatment arms (BMS-986036 Dose Level 1, Dose Level 2, Dose Level 3 or matching placebo), as defined in the respective BMS sponsored protocols.

Cohort 1 consists of Subjects with NASH and stage 3 fibrosis, as assessed by a central laboratory reader of the liver biopsies (up to 160), and who meet all the NCT03486899 referenced study criteria.

Cohort 2 consists of Subjects with NASH and compensated liver cirrhosis, as assessed by a central laboratory reader of the liver biopsies (up to100), and who meet all the NCT03486912 referenced study criteria.

Approximately 75 sites will be included in the BMS studies, but not all participating sites will elect to perform the MBT. Each subject will perform up to 3 MBTs over 1 year; approximately one every 24 weeks.

The MBT in this study will only be conducted in the USA.

The primary purpose of the BMS study is to assess an experimental treatment for the following conditions: Hepatic cirrhosis, liver fibrosis, Nonalcoholic Fatty Liver Disease (NAFLD) and NASH (Nonalcoholic Steatohepatitis).

Enrollment: 124 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Liver biopsy performed within 6 months prior to the Screening Visit; if not performed within 6 months prior to the Screening Visit, a liver biopsy will be performed during the Screening Period and at least 4 weeks prior to randomization (Biopsy must be consistent with NASH, with: a) A score of at least 1 for each NAS component (steatosis, lobular inflammation, and ballooning), as assessed by the central reader AND b) Stage 3/Stage 4 (Cirrhosis) liver fibrosis (cohort 1 and cohort 2 respectively) according to the NASH CRN (Clinical Research Network) classification, as assessed by the central reader
2. Participants taking anti-diabetic, anti-obesity, or anti-dyslipidemic medications must have been on stable dosing regimens for at least 3 months prior to the Screening Visit
3. Participants taking vitamin E at doses ≥800 IU/day must have been on stable doses for at least 6 months prior to the Screening Visit (Vitamin E treatment must not have been initiated after the liver biopsy was performed)-

Exclusion criteria

1. Other causes of liver disease (e.g., alcoholic liver disease, hepatitis B virus infection, chronic hepatitis C virus infection, autoimmune hepatitis, drug-induced hepatotoxicity, Wilson disease, alpha-1-antitrypsin deficiency, iron overload, and hemochromatosis)
2. Current or past history of hepatocellular carcinoma (HCC)
3. Past or current evidence of hepatic decompensation (e.g., ascites, variceal bleeding, hepatic encephalopathy and/or spontaneous bacterial peritonitis) or liver transplantation Other protocol defined inclusion/exclusion criteria could apply

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

124 participants in 4 patient groups, including a placebo group

BMS-986036 Dose Level 1

Experimental group

Description:

Administered by subcutaneous injection

Treatment:

Combination Product: ¹³C-Methacetin Breath Test

Drug: BMS-986036

Device: BreathID MCS device

BMS-986036 Dose Level 2

Experimental group

Description:

Administered by subcutaneous injection

Treatment:

Combination Product: ¹³C-Methacetin Breath Test

Drug: BMS-986036

Device: BreathID MCS device

BMS-986036 Dose Level 3

Experimental group

Description:

Administered by subcutaneous injection

Treatment:

Combination Product: ¹³C-Methacetin Breath Test

Drug: BMS-986036

Device: BreathID MCS device

Placebo

Placebo Comparator group

Description:

Administered by subcutaneous injection

Treatment:

Combination Product: ¹³C-Methacetin Breath Test

Drug: BMS-986036

Device: BreathID MCS device