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In small proof-of-concept phase 2 randomized controlled trials (RCTs) in patients with biopsy-confirmed MASH, liraglutide at 1.8 mg/day for 48 weeks (201), semaglutide at 0.4 mg/day for 72 weeks (202), and tirzepatide at 15 mg/week for 52 weeks (203) have been reported to achieve placebo-corrected percentages of participants meeting the criteria for resolution of MASH without worsening fibrosis by 30% (P = 0.019), 42% (P 10%) may lead to diabetes remission (237)
After failing a Phase 3 trial in spinal muscular atrophy, Biohaven pivoted to obesity
Ethical approval was obtained from the Institutional Review Board of Princess Nourah Bint Abdulrahman University), Saudi Arabia
The findings raise serious concerns about safety, labeling inconsistencies, and a near-total absence of human clinical trial data behind most of the claims being made online
