randomized_controlled_trial · 2021
Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial
Lau DCW, Erichsen L, Francisco AM, et al. · The Lancet
moderateDOI · 10.1016/s0140-6736(21)01751-7PMID · 34798060Trial · nct03856047Verified
Plain-English summary
Cagrilintide produced dose-dependent weight loss over 26 weeks, but it remained an investigational medicine and gastrointestinal adverse effects were common.
Population
Adults without diabetes with obesity or overweight plus at least one weight-related complication
Sample size
706
Intervention
Once-weekly cagrilintide 0.3 mg to 4.5 mg versus placebo, with liraglutide 3.0 mg as an active comparator, for 26 weeks
Outcomes measured
Percentage change in body weight|Weight-loss thresholds|Safety and tolerability
Key findings
Cagrilintide produced significantly greater, dose-dependent weight reduction than placebo; gastrointestinal disorders were the most frequent adverse events.
Funding & disclosures
Funded by Novo Nordisk; multiple authors were employees or reported financial relationships with the sponsor.
Limitations
The study was phase 2, treatment lasted 26 weeks and the active comparator was open label. Longer-term safety, durability and clinical outcomes were not established.Risk of bias
Moderate — randomized and double-blind for cagrilintide versus placebo, but commercially sponsored with an open-label active comparator.Citation
Lau DCW, Erichsen L, Francisco AM, et al. (2021). Once-weekly cagrilintide for weight management in people with overweight and obesity: a multicentre, randomised, double-blind, placebo-controlled and active-controlled, dose-finding phase 2 trial. The Lancet. https://doi.org/10.1016/s0140-6736(21)01751-7
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