Human evidence record · Orforglipron

ACHIEVE-1: orforglipron in early type 2 diabetes

HbA1c fell by about 1.24-1.48 percentage points versus 0.41 with placebo; weight fell up to 7.6% versus 1.7% placebo.

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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 managed with diet and exercise

How many?

n=559

What happened?

HbA1c fell by about 1.24-1.48 percentage points versus 0.41 with placebo; weight fell up to 7.6% versus 1.7% placebo.

What stops us overclaiming?

Study population had early T2D; approved U.S. obesity indication and current commercial dosing are separate label questions.

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Key result

HbA1c fell by about 1.24-1.48 percentage points versus 0.41 with placebo; weight fell up to 7.6% versus 1.7% placebo.

Study details

Study designRandomized, double-blind, placebo-controlled trial

PhasePhase III

PopulationAdults with type 2 diabetes managed with diet and exercise

Sample size559

RouteOral

Regimen / exposure3, 12 or 36 mg once daily in the trial formulation

Duration40 weeks

ComparatorPlacebo

Primary endpoint / questionChange in HbA1c; body weight secondary endpoint

Safety resultMostly mild-to-moderate GI events; discontinuation due to adverse events occurred more often with active drug.

Key limitationsStudy population had early T2D; approved U.S. obesity indication and current commercial dosing are separate label questions.

Registry / identifierNCT05971940

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