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Compound monograph · evidence extract

Cagrilintide in obesity and overweight in adults — evidence extract

The Institute's graded assessment of Cagrilintide for obesity and overweight in adults, with the contributing trials and the domain-by-domain certainty reasoning.

Document identifier
CEI-MN-005/EV-OBESITY
Series
Evidence extract
Version
4.3
Published
06 Nov 2023
Last reviewed
06 Feb 2025
Next review
06 Feb 2027
Identifier
10.71829/cei.mono.5
Certainty
Moderate
Cycle
2023 Q4

§1Evidence extract: Obesity and overweight in adults

§1.1Question and anchor outcome

Population
Excess adiposity sufficient to impair health, operationalised in the pivotal incretin programmes as a body-mass index of 30 kg/m² or above, or 27 kg/m² or above with at least one weight-related comorbidity.
Intervention
Cagrilintide, subcutaneous once weekly
Comparator
As used in each contributing trial; reported per trial rather than pooled across comparator types
Anchor outcome
Percentage change in body weight from baseline

Additional outcomes the Institute extracts for this indication: Proportion achieving ≥5 %, ≥10 %, ≥15 % and ≥20 % weight reduction; Change in waist circumference; Change in systolic blood pressure; Change in high-sensitivity C-reactive protein.

§1.2Contributing trials

Table 1. Trials contributing to the assessment of Cagrilintide in obesity and overweight in adults.

TrialPhaseDesignRandomisedDurationYear
CAGRI-PH2-DOSEFIND2Dose-finding70626 weeks2021
REDEFINE-13Randomised, double-blind, placebo-controlled3,41768 weeks2025

§1.3Certainty assessment

Certainty assessment by domainDowngrading decision recorded for each certainty domain.Certainty domainNo concernSeriousVery seriousEffect on ratingRisk of biasno downgradeInconsistencydowngrade one levelIndirectnessno downgradeImprecisionno downgradePublication biasno downgradeTotal downgrading: 1 levelModerate certainty
Figure 2. Domain-by-domain certainty assessment for Cagrilintide in obesity and overweight in adults. The starting rating for a body of randomised evidence is high; each serious concern reduces it by one level and each very serious concern by two.

Table 2. Reasoning recorded against each certainty domain.

DomainRatingReasoning
Risk of biasNo concernNo serious concern identified in this domain.
InconsistencySeriousToo few contributing studies to assess consistency formally.
IndirectnessNo concernNo serious concern identified in this domain.
ImprecisionNo concernNo serious concern identified in this domain.
Publication biasNo concernNo serious concern identified in this domain.
Overall rating: Moderate certainty. The true effect is likely to be close to the estimate, but there is a possibility that it is substantially different. Further research is likely to have an important impact on confidence in the estimate.

§1.4What this extract does not establish

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.

  1. 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
  2. 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
  3. Hollander PA, Levy P, Fineman MS, Maggs DG, Shen LZ, Strobel SA, Weyer C, Kolterman OG. Pramlintide as an adjunct to insulin therapy improves long-term glycemic and weight control in patients with type 2 diabetes: a 1-year randomized controlled trial. Diabetes Care 2003;26(3):784–790. doi:10.2337/diacare.26.3.784 · PMID 12610038

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