glp 1 drugs fda approved Wegovy Pill Wins Approval as First GLP-1 Oral Treatment for Obesity and Weight Loss US FDA Approves Wegovy Pill

PMCID: PMC3650111

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Phase 2 and Phase 3 trial data Major clinical trials: Phase 2 (24-week trial, 2008): 203 obese participants Three dose groups: 0.25mg, 0.5mg, 1.0mg daily Placebo-controlled, randomized Primary outcome: Weight loss percentage Phase 2 results: Key findings: Dose-dependent weight loss 1mg dose: Average 23 lbs lost (starting weight ~220 lbs) Best responders: 15-20% weight loss Comparable to semaglutide 2.4mg But higher dropout due to side effects Phase 3 trials (planned but never completed): Intended for FDA approval Halted due to cardiovascular concerns Increased heart rate 5-10 bpm average Blood pressure elevation 2-5 mmHg Risk-benefit ratio questioned Development suspended 2010 Long-term data (limited): 1-year extension studies showed sustained loss Weight plateau at 6-9 months Some regain if discontinued No controlled trials beyond 1 year Safety concerns prevented longer studies Compare to semaglutide trials and tirzepatide results