A Study to Evaluate Safety and Pharmacodynamic Efficacy of 0382 in Obese Subjects With NAFLD/NASH.

What Was Tested

The trial (phase 2) is built around Cotadutide for fatty liver & elevated liver enzymes.

The subjects will have biopsy-confirmed NAFLD/NASH with liver fibrosis stage F1, F2 or F3.

Approximately 72 subjects will be randomized.

It had four arms (groups): one (experimental), one (placebo comparator), one (experimental) and one (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Approximately 72 subjects will be randomized across multiple study sites.

Who Took Part

Enrollment: 74 actual participants took part.

It was open to people of any sex aged from 18 years up to 101 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Provision of informed consent (with the exception of consent for future genetic and non genetic research) prior to performing any study-specific procedures, including screening evaluations. Subjects aged ≥ 18 years at the time of consent. Body mass index ≥ 30 kg/m2 at screening. Women of childbearing potential:.

The full record lists 9 inclusion and 38 exclusion criteria; among the exclusions: history of cirrhosis and/or hepatic decompensation, including ascites, hepatic encephalopathy or variceal bleeding; prior or planned liver transplantation; evidence of alcohol dependence as assessed by the alcohol use disorder identification test (audit) questionnaire at screening.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got Cotadutide and who got the comparison, which limits bias.

The Cotadutide group and the comparison group ran side by side rather than switching.

As a double-blind Cotadutide study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2019-09-23 with completion listed for 2021-05-06.

It ran at 27 sites in United States (26) and Puerto Rico (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Safety (Including Hepatic Safety) and Tolerability of MEDI0382 Compared With Placebo: Number of Participants With TEAE and SAE (time frame: Day 1 - Day 161).

It also tracked 15 secondary outcomes, for example Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): ADA Titer (if Confirmed Positive), Immunogenicity Profile Defined by Presence of Anti-drug Antibodies (ADA): Number of Participants With Development of ADA, Change From Baseline to Week 19 in Hepatic Fat Fraction (HFF), Percent Change From Baseline to Week 19 in Liver Volume, Percent Change From Baseline to Week 19 in Liver Fat Volume and Percent Change From Baseline to Week 19 in Visceral Adipose Tissue.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Cotadutide in 74 people with fatty liver & elevated liver enzymes.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Cotadutide compound page, Fatty liver & elevated liver enzymes research.