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Oral small molecule GLP-1 receptor agonist aleniglipron in people with overweight or obesity: a randomized, double-blind, placebo-controlled phase 2b trial - PubMed

4 hours ago
  • #Clinical Trial
  • #Obesity
  • #GLP-1 Agonist
  • Adeniglipron is an oral GLP-1 receptor agonist being developed for obesity treatment, evaluated in a phase 2b trial.
  • The study involved 230 overweight or obese adults with a mean BMI of 39.5 kg/m², randomized to once-daily aleniglipron at 45 mg, 90 mg, or 120 mg doses, escalated every 4 weeks.
  • At week 36, aleniglipron showed significant weight loss compared to placebo: -8.2% (45 mg), -9.8% (90 mg), and -11.3% (120 mg), with no plateau observed by the end of the double-blind period.
  • Continued weight loss was noted in an ongoing open-label extension, with a median treatment duration of 20 weeks at interim analysis.
  • Gastrointestinal side effects were mostly mild to moderate, decreasing over time, and vomiting rarely recurred after dose interruptions and reintroduction.
  • Treatment discontinuations due to adverse events were 10.4% across aleniglipron groups, with no cases of drug-induced liver injury reported.
  • The tolerability profile aligns with the GLP-1 receptor agonist class, supporting further development of aleniglipron for obesity treatment.