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Nevertheless, the GLP-1 receptor agonist has been prescribed for people with obesity who have weight-related cardiovascular disease
Whereas, it is the glycine in this position of exenatide that is well resistant to be degraded by DPP-4
What the FDA Requires in the BLA Efficacy Data: TRIUMPH-4: 28.7% weight loss Complete TRIUMPH-1: 28.3% weight loss Complete TRIUMPH-2: 20.8% weight loss (obesity + diabetes) Complete TRIUMPH-3: 22.6% weight loss (obesity + cardiovascular disease) Complete, MACE data not statistically significant Safety Data: Side effect profile across all four populations Short-term and medium-term adverse events, including the dysesthesia signal (up to 20.9% at 12mg) Drug interactions, especially with diabetes medications Manufacturing Data: Scale-up capability for millions of doses per month Quality control and stability data Cold chain distribution logistics Realistic Approval Scenarios With the BLA filing point now expected (Q1 2027), the remaining uncertainty is largely in the FDA review itself not in whether or when Lilly files
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Discontinuation, regain, and reinitiation (class-level, semaglutide / tirzepatide) Budini 2026 ( eClinicalMedicine ) pooled regain curve: asymptotic maximum regain 75.3% of lost weight, half-life about 23 weeks, so roughly 60% of the loss returns by 12 months and about 40% is still held at a year
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