Summary:
In healthy Chinese adults, once-daily oral semaglutide (3 mg escalating to 14 mg over 12 weeks) significantly reduced body weight (p = .0001) and fasting plasma glucose (p = .0011) compared to placebo under identical study conditions, though it was associated with primarily gastrointestinal adverse events.
PICO | Description |
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Population | Healthy Chinese adults, 32 participants, randomized to receive either oral semaglutide or placebo for 12 weeks. |
Intervention | Once-daily oral semaglutide (3 mg escalating to 14 mg) administered over 12 weeks to assess pharmacokinetics, pharmacodynamics, safety, and tolerability. |
Comparison | Placebo group with identical study conditions to evaluate the treatment effect and safety of oral semaglutide. |
Outcome | Dose-dependent increases in semaglutide exposure demonstrated by AUC and Cmax. Significant reductions in body weight (p = .0001) and fasting plasma glucose (p = .0011) compared to placebo. No severe or blood-glucose-confirmed symptomatic hypoglycemic events, serious adverse events, or deaths. Adverse events were primarily gastrointestinal disorders. |
Source: Panpan Xie, et al. “A Phase 1, Randomized, Double-Blind, Placebo-Controlled Trial Investigating the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Oral Semaglutide in Healthy Chinese Subjects.” Diabetes, Obesity and Metabolism. Read article here.