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Human evidence record · Retatrutide

TRANSCEND-T2D-1: Retatrutide in adults with type 2 diabetes inadequately controlled with diet and exercise

Mean HbA1c change was -1.69%, -1.86% and -1.94% with retatrutide 4/9/12 mg versus -0.81% with placebo; mean body-weight change was -11.5%, -13.9% and -15.3% versus -2.6%.

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Human evidence record

What this study tells us

Participants were assigned to comparison groups by chance, usually with placebo and/or blinding to reduce bias. This is a strong design for testing cause and effect, but the population, duration and endpoints still limit what can be concluded.

Who was studied?

Adults with type 2 diabetes inadequately controlled with diet and exercise alone; HbA1c 7.0–9.5% and BMI ≥23 kg/m²

How many?

n=537

What happened?

Mean HbA1c change was -1.69%, -1.86% and -1.94% with retatrutide 4/9/12 mg versus -0.81% with placebo; mean body-weight change was -11.5%, -13.9% and -15.3% versus -2.6%.

What stops us overclaiming?

40-week trial in adults with relatively early type 2 diabetes controlled only by diet/exercise; it does not establish long-term cardiovascular outcomes or approval for obesity.

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Key result

Mean HbA1c change was -1.69%, -1.86% and -1.94% with retatrutide 4/9/12 mg versus -0.81% with placebo; mean body-weight change was -11.5%, -13.9% and -15.3% versus -2.6%.

Study details

Study designRandomized, double-blind, placebo-controlled Phase 3 trial
PhasePhase 3
PopulationAdults with type 2 diabetes inadequately controlled with diet and exercise alone; HbA1c 7.0–9.5% and BMI ≥23 kg/m²
Sample size537
RouteSubcutaneous
Regimen / exposureRetatrutide 4 mg, 9 mg or 12 mg once weekly; placebo
Duration40 weeks
ComparatorPlacebo
Primary endpoint / questionChange in HbA1c to week 40; key secondary outcome was percentage body-weight change
Safety resultThe most frequent adverse events were generally mild-to-moderate gastrointestinal events. Adverse-event discontinuations were 2–5% with retatrutide and 0% with placebo; no severe hypoglycaemia was reported.
Key limitations40-week trial in adults with relatively early type 2 diabetes controlled only by diet/exercise; it does not establish long-term cardiovascular outcomes or approval for obesity.
Registry / identifierPMID 42250575 / NCT06354660