TESA-NAFLD-PH2 — design and population

§2Design and population

§2.1Design and allocation

Design class

Randomised, double-blind, placebo-controlled, parallel-group

Masking

Double-blind (participant, investigator and sponsor)

Arms

5

Allocation

Randomised across dose arms and a common comparator

Endpoint adjudication

Not applicable to the primary endpoint of this design

Data monitoring

As specified in the protocol

§2.2Arms

Table 2. Randomised arms. Illustrative: arm-level allocations are reconstructed by the Institute from the design class and the randomised total where the published report does not state them.

§2.3Population

Indication. Metabolic dysfunction-associated steatohepatitis

Steatotic liver disease with histological evidence of hepatocyte ballooning and lobular inflammation occurring in the context of at least one cardiometabolic risk factor. Formerly termed non-alcoholic steatohepatitis.

Geographic footprint. France · Taiwan · Argentina · China.

§2.4Eligibility as the Institute reads it

• Included. Steatotic liver disease with histological evidence of hepatocyte ballooning and lobular inflammation occurring in the context of at least one cardiometabolic risk factor. Formerly termed non-alcoholic steatohepatitis.
• Excluded. Participants for whom the intervention is contraindicated, including disruption of the hypothalamic-pituitary axis from hypophysectomy, hypopituitarism…. Exclusion criteria narrow the population to which the estimate applies and are the principal source of indirectness where a trial estimate is applied to ordinary practice.