What is worth noting this time is not just the number of 21%, but that the lower-dose combination also produced an effect. The answer given by REDEFINE 9 still needs to be viewed in the context of the trial population, comparator, and analysis method.
This article looks only at REDEFINE 9
The announcement dated September 21 mentioned two trials at the same time. REDEFINE 9 studied adults with overweight or obesity, comparing CagriSema with placebo, and observed for 68 weeks; the other trial, REIMAGINE 5, studied type 2 diabetes and used tirzepatide as the comparator.
The populations and comparators of the two trials are different. What is discussed here is REDEFINE 9, and its 21% cannot be directly treated as the gap between two drugs when compared with the 9.1% from another trial.
21% and 2%, how should the difference be calculated?
The announcement reported that the 1.0 milligram/1.0 milligram combination group had an average weight loss of 21.0%, while the placebo group had 2.0%, using the efficacy estimand. Subtracting the two gives 19 percentage points.[1]
Assuming both groups started at 100 kilograms, 21% and 2% correspond to reductions of 21 kilograms and 2 kilograms, respectively. This is a hypothetical example to help understand percentages, not the participants' actual starting weight, and it does not mean every person reached the average.
Why is it called a lower dose?
Here, "lower" means compared with the higher-dose regimens in this combination's development program. The two milligram amounts correspond to two components, respectively; they are not together called a "one-milligram combination."[1]
Milligram amounts of different molecules cannot be directly compared for potency. It is like putting one gram each of salt and sugar; their effects are not the same. A peptide's receptor action, residence time in the body, and formulation can all affect the results.
Why is it worth taking a look at the efficacy estimand?
Clinical trials handle discontinuation, rescue treatment, and missing data in different ways. The efficacy estimand usually answers a question closer to "what would happen if the study treatment were continued," while another type of estimand places more emphasis on the overall situation regardless of whether treatment was continued.
The announcement gives top-line results, not yet a paper with all details fully disclosed. When comparing other studies, first confirm that the analysis estimand is consistent, to avoid mixing answers to two different questions.
Besides weight loss, what other information is still missing?
A subsequent full report should help us understand adverse reactions, discontinuation proportions, performance at different doses, and individual differences. The announcement said the overall tolerability was consistent with previous studies, but this cannot replace specific adverse reaction numbers.
This news supports the value of continuing research into lower-dose combinations. It does not constitute a basis for self-compounding, increasing the dose, or switching medications.
Why can't two drugs be ranked by milligram amount?
The milligram is a unit of mass, not a unit of potency. Different molecules act on receptors in different ways and are absorbed and cleared differently, so "fewer milligrams" does not automatically mean "weaker drug effect."
Dose studies of the same molecule should be compared under similar conditions; for efficacy comparisons between different molecules, it is best to look at direct head-to-head trials. Picking out the largest numbers from different studies often ignores differences in populations and timing.
View materials and analysis information
The cagrilintide catalog information is suitable for checking amylin-related experimental materials. Research raw materials are not equivalent to the clinical combination formulation of REDEFINE 9.
Cagrilintide · Cagrilintide
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