CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 124 enrolled
Drug / intervention
¹³C-Methacetin Breath Test +2 morecombination
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03611101
NCT03611101N/ACompleted
CompareCT.gov

Companion Protocol for the ¹³C-Methacetin Breath Test (MBT) for Use in Bristol-Myers Squibb Phase 2b Studies for BMS-986036 (PEG-FGF21), Under Studies Referenced in NCT03486899, NCT03486912

Meridian Bioscience, Inc.·interventional·Posted Aug 2, 2018·Updated Dec 20, 2022

In Brief

A clinical study evaluating ¹³C-Methacetin Breath Test, BMS-986036, and 1 other intervention for NASH - Nonalcoholic Steatohepatitis. Completed, enrolled 124 participants across 1 site.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsNASH - Nonalcoholic Steatohepatitis
CountriesUnited States
CollaboratorsBristol-Myers Squibb

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 2, 2018
Enrollment StartMay 4, 2018
Primary CompletionAug 18, 2020
Study CompletionNov 10, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 7.9 years ago

Interventions

¹³C-Methacetin Breath Testcombination

A breath analyzer will be used to measure changes in 12C (carbon 12) to 13C (carbon 13) ratio as a result of metabolism of the Methacetin substrate before and after treatment.

BMS-986036drug

Investigational drug for NASH treatment in Main BMS protocol

BreathID MCS devicedevice

The BreathID MCS device is a breath analyzer specifically used for measuring changes in the ratio of 13CO2 and 12CO2 isotopes of carbon dioxide. The device is connected to the subject via a nasal cannula and breath is passively collected before and after ingestion of labelled 13C- Methacetin substrate.