CagriSema (cagrilintide with semaglutide) — clinical evidence
Assessed outcomes with certainty ratings, contributing trials and the reasoning for each rating.
§3Clinical evidence
§3.1Obesity and overweight in adults
Anchor outcome. Percentage change in body weight from baseline.
Effect as recorded. −22.7 % body weight at 68 weeks versus −2.3 % with placebo in adults with obesity without diabetes; estimated difference −20.4 percentage points (95 % CI −21.7 to −19.1).[1,2]
Certainty. Moderate certainty Large phase 3 trial. Downgraded one level because the observed effect fell below the sponsor-stated expectation and because a substantial proportion of participants did not reach the highest planned dose, which complicates interpretation of the dose-effect relationship.
Contributing trials. REDEFINE-1 · REDEFINE-2 · REDEFINE-4. Full structured abstracts are published for each.
Full evidence extract for obesity and overweight in adults · Indication assessment
§3.2Type 2 diabetes mellitus
Anchor outcome. Change in HbA1c (%, mmol/mol).
Effect as recorded. −13.7 % body weight and −1.8 % HbA1c at 68 weeks in type 2 diabetes; weight difference −10.4 percentage points (95 % CI −11.9 to −8.9).[2,3]
Certainty. Moderate certainty Attenuated weight effect in diabetes, consistent with the pattern seen across the incretin class.
Contributing trials. REDEFINE-2. Full structured abstracts are published for each.
Full evidence extract for type 2 diabetes mellitus · Indication assessment
References cited on this page
References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.
- Frías JP, Deenadayalan S, Erichsen L, Knop FK, Lingvay I, Macura S, Mathieu C, Pedersen SD, Davies M. Efficacy and safety of co-administered once-weekly cagrilintide 2·4 mg with once-weekly semaglutide 2·4 mg in type 2 diabetes: a multicentre, randomised, double-blind, active-controlled, phase 2 trial. The Lancet 2023;402(10403):720–730. doi:10.1016/S0140-6736(23)01163-7 · PMID 37364591
- Lau DCW, Erichsen L, Francisco AM, Satylganova A, le Roux CW, McGowan B, Pedersen SD, Pietiläinen KH, Rubino DM, Batterham RL. 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 2021;398(10317):2160–2172. doi:10.1016/S0140-6736(21)01751-7 · PMID 34798060
- Wilding JPH, Batterham RL, Calanna S, Davies M, Van Gaal LF, Lingvay I, McGowan BM, Rosenstock J, Tran MTD, Wadden TA, Wharton S, Yokote K, Zeuthen N, Kushner RF. Once-weekly semaglutide in adults with overweight or obesity. New England Journal of Medicine 2021;384(11):989–1002. doi:10.1056/NEJMoa2032183 · PMID 33567185
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