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What are the options for stepping down the dose
Trial Structure Duration: 48 weeks of treatment Participants: 338 adults randomized 2:1:1:1:1:2:2 to placebo or retatrutide groups Doses tested: 1mg, 4mg, 8mg, 12mg (all with slow titration from 2mg starting dose) Lifestyle intervention: All participants received counseling on diet (500 kcal/day deficit) and exercise (150 min/week) Primary endpoint: Percent weight change at 24 weeks Key secondary endpoints: Weight change at 48 weeks, proportion achieving 5%, 10%, 15% loss The trial used a slow titration protocol to minimize side effects: all groups except the 1mg dose started at 2mg weekly and escalated every 4 weeks
15 Participants: A total of 251 adolescents were enrolled and randomized to receive either liraglutide (3.0 mg once daily) or placebo
The litigation focuses on severe side effects allegedly not adequately warned about by the manufacturers
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