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A randomized, double-blind, placebo-controlled phase 2 study comparing the efficacy and safety of tirzepatide versus placebo in 196 patients with nonalcoholic steatohepatitis (SYNERGY-NASH) with or without diabetes is currently underway and is estimated to complete in 2024
Making informed decisions up front can reduce risk, improve efficiency, and help ensure a smooth path to commercialization
A potential trial will require large sample sizes and a lengthy duration
The underlying reason is in the FDA label: cases of acute kidney injury have been reported, some requiring hemodialysis, mostly in people whose gastrointestinal reactions such as nausea, vomiting, or diarrhea led to dehydration
Subgroup analysis revealed interesting patterns
