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Human evidence record · Cagrilintide

REDEFINE 1 cagrilintide 2.4 mg monotherapy arm

Detailed REDEFINE 1 reporting shows about 11.5% treatment-policy / 11.8% trial-product-estimand weight reduction with cagrilintide 2.4 mg monotherapy versus about 3.0% / 2.3% placebo.

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Human evidence record

What this study tells us

This was a human pharmacology or physiology study. It can show what the compound does to measured biological signals, but it may not establish a meaningful clinical benefit.

Who was studied?

Adults without diabetes with obesity or overweight plus complication

How many?

n=302 cagrilintide arm

What happened?

Detailed REDEFINE 1 reporting shows about 11.5% treatment-policy / 11.8% trial-product-estimand weight reduction with cagrilintide 2.4 mg monotherapy versus about 3.0% / 2.3% placebo.

What stops us overclaiming?

The main NEJM paper emphasizes CagriSema; monotherapy values must retain their stated estimand and should not be mixed with combination results.

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Key result

Detailed REDEFINE 1 reporting shows about 11.5% treatment-policy / 11.8% trial-product-estimand weight reduction with cagrilintide 2.4 mg monotherapy versus about 3.0% / 2.3% placebo.

Study details

Study designRandomized, double-blind, placebo- and active-controlled Phase IIIa trial; monotherapy arm within larger trial
PhasePhase IIIa
PopulationAdults without diabetes with obesity or overweight plus complication
Sample size302 cagrilintide arm
RouteSubcutaneous
Regimen / exposureCagrilintide 2.4 mg once weekly with dose escalation
Duration68 weeks
ComparatorPlacebo; semaglutide; CagriSema arms
Primary endpoint / questionBody-weight change and categorical weight-loss outcomes
Safety resultGI adverse events were common but discontinuation due to GI events was low in the cagrilintide arm.
Key limitationsThe main NEJM paper emphasizes CagriSema; monotherapy values must retain their stated estimand and should not be mixed with combination results.
Registry / identifierNCT05567796
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