In short
MK-7480 is an investigational substance, meaning it is not yet an authorised medicine. It is being studied in non-alcoholic steatohepatitis (NASH), a liver disease. The clinical trial data currently available comes from one completed Phase 1 study in 36 healthy adult male participants, which assessed the safety, tolerability, and how the body processes the substance.
Key points
- MK-7480 is an investigational substance studied in non-alcoholic steatohepatitis (NASH).
- The only registered trial is a Phase 1 study, which is completed.
- The trial enrolled 36 healthy adult male participants, not patients with NASH.
- The study assessed safety, tolerability, and pharmacokinetics after single oral doses.
- MK-7480 was given orally at a dose of 300 mg in the trial.
- The trial also included a comparison with diltiazem hydrochloride and a placebo.
What is MK-7480?
MK-7480 is an investigational substance, meaning it has not yet received marketing authorisation as a medicine. It is being developed for research in non-alcoholic steatohepatitis (NASH), a form of liver disease characterised by fat accumulation, inflammation, and liver cell damage in people who drink little or no alcohol. The substance is classified under the therapeutic area of digestive system diseases in the clinical trial registry.
How does MK-7480 work?
The available registry data for the completed Phase 1 trial does not describe the mechanism of action of MK-7480. The study was designed to assess safety, tolerability, and pharmacokinetics in healthy participants, rather than to test efficacy in a disease population. No further information on the molecular target or mechanism is provided in the sources.
Which conditions is MK-7480 studied for?
- Non-alcoholic steatohepatitis (NASH) — a progressive liver disease in which fat builds up in the liver, leading to inflammation and damage, and which can progress to cirrhosis or liver cancer. The Phase 1 trial is registered under this condition, although the participants were healthy volunteers rather than people with NASH.
How is MK-7480 given?
In the registered clinical trial, MK-7480 was administered orally as a single dose of 300 mg. The pharmaceutical form used in the trial is not further specified in the registry data. No other formulations or routes of administration are described in the available sources.
What do the clinical trials show?
There is one registered clinical trial for MK-7480. It is a Phase 1, interventional study that has been completed. The trial enrolled 36 healthy adult male participants. The primary objective was to assess the safety and tolerability of single ascending oral doses of MK-7480, as well as its plasma pharmacokinetics.
The primary outcomes measured in the trial included the percentage of participants who experienced one or more adverse events, the percentage who discontinued the study due to an adverse event, and several pharmacokinetic measures. These pharmacokinetic measures included the area under the concentration curve (AUC0-inf and AUC0-24), which describes how much of the drug is in the blood over time, the maximum concentration (Cmax), the time to reach maximum concentration (Tmax), the concentration at 24 hours (C24), and the apparent terminal half-life (t1/2).
The trial also included a comparison arm with diltiazem hydrochloride at 240 mg orally, and a placebo arm containing microcrystalline cellulose, lactose monohydrate, and magnesium stearate.
What side effects are known?
The available sources do not report specific side effects of MK-7480. The Phase 1 trial measured adverse events as a primary outcome, but the results are not provided in the registry data.