1. By week 26, cagrilintide resulted in significantly increased weight reduction compared to liraglutide and placebo.
2. Gastrointestinal adverse events, such as nausea, constipation, and diarrhea, were more common in the cagrilintide group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Cagrilintide is a synthetic amylin analogue used to induce satiety in patients. Currently, most guidelines recommend lifestyle interventions as first line for weight management. Pharmacotherapy is limited to only a few drugs, including GLP-1 receptor agonists. With obesity becoming a widespread problem, exploring alternative options for obesity and weight management is key. This randomized controlled trial aimed to assess the efficacy, safety, and tolerability of cagrilintide 0.3-4.5 mg, compared to liraglutide 3.0 mg and placebo, in patients with a body-mass index (BMI) in the overweight and obesity ranges. The primary outcome was the mean change in bodyweight from baseline to week 26 after randomization, while key secondary outcomes included change in waist circumference, lipid levels, and glycemic control. According to results, patients in the cagrilintide group reported significantly greater reduction in bodyweight compared to liraglutide and placebo at week 26.
Relevant Reading: Once-Weekly Semaglutide in Adults with Overweight or Obesity
In-depth [randomized controlled trial]: Between Mar 1 and Aug 19, 2019, 886 patients were assessed for eligibility across 57 sites in 10 countries. Included were those ≥18 years of age with BMI ≥27 kg/m2, with hypertension or dyslipidemia, and no diabetes. Altogether, 706 patients were included (100-102 each to cagrilintide 0.3, 0.6, 1.2, 2.4, or 4.5 mg, 99 to liraglutide 3.0 mg, and 101 to placebo) in the final analysis. The primary outcome of bodyweight reduction was greater among patients in the cagrilintide group than placebo (estimated treatment difference [ETD] range 3.0%-7.8%, p<0.001). A similar pattern was noticed for cagrilintide 4.5 mg versus liraglutide 3.0 mg (10.8% vs. 9.0%, ETD 1.8%, p=0.03). Patients across all cagrilintide doses reported similar rates of adverse gastrointestinal events compared to liraglutide, including nausea, constipation, and diarrhea. However, when comparing cagrilintide 0.3-4.5 mg to placebo, a greater number of GI adverse events (41%-63% vs. 32%) were noted. Overall, findings from this study suggest that cagrilintide may be effective in the management of overweight and obese patients.
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