I also expect an extension study...if all proceeds well.
Like the previous metabolic trials, Corcept isn't aiming for statistical significance (they got it anyways). Three months should be enough to see the changes in the markers. Will Miricorilant have enough time to reduce pathogenic fat in the liver? Everything else will follow: inflammatory markers, MRI scans, fibrotic markers, etc.
Looking at the prior drug trials with AIWG, this should be enough time between miricorilant versus placebo groups on just about every marker. The gamble is whether it's enough time for the MRI scans. In the conference calls, Belanoff referred discussion about the 900mg AIWG group to the publication.
Remember the surprising result? Miricorilant aided liver health. Corcept and its investigators can map the results to specific patients. I will bet that it was the "obese normals" that experienced the most benefit.
With NASH patients, some should be pretty darn obese. This should be an interesting test of miricorilant's ability to realign the HPA system (AKA Cortisol System Overdrive).
Corcept has been receiving data about Cushing's and Adrenal Adenoma patients resolve their liver problems with Korlym and relacorilant.
Also I was expecting a longer follow-up, but maybe they will do that if they see a good initial effect by offering an extension study.
If it goes well, I'd be surprised if there wasn't an extension. They might as well put the placebo patients on miricorilant and collect additional data. Corcept should also want the longer-term safety data.
Lastly if it is just 120 subjects and a 3 month trial in NASH why are they projecting 18 months to completion. NASH is no orphan disease and unless they are deliberately going at old Corcept slow speed, they should be able to wrap up the trial in less than a year.
I noticed the AIWG trials were projected slower, largely because of COVID. I think the same goes for NASH. Everyone and their brother is clogging up university pipelines with NASH trials with interesting and worthless drugs.
At the same time, Universities were charging more and moving slower. This was already occurring before COVID. I heard the complaints from various teams in 2018-19.
And now? I can't see that it got any better.