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Human evidence record · Survodutide

Survodutide for obesity: randomized Phase 2 dose-finding trial

Mean weight changes were approximately -6.2%, -12.5%, -13.2% and -14.9% across ascending doses vs -2.8% placebo.

Quick read
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 overweight or obesity

How many?

n=387

What happened?

Mean weight changes were approximately -6.2%, -12.5%, -13.2% and -14.9% across ascending doses vs -2.8% placebo.

What stops us overclaiming?

Phase 2 size/duration; dose escalation and discontinuations affect estimands; no long-term outcomes.

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Key result

Mean weight changes were approximately -6.2%, -12.5%, -13.2% and -14.9% across ascending doses vs -2.8% placebo.

Study details

Study designRandomized, double-blind, placebo-controlled dose-finding trial
PhasePhase 2
PopulationAdults with overweight or obesity
Sample size387
RouteSubcutaneous
Regimen / exposure0.6, 2.4, 3.6 or 4.8 mg once weekly with escalation
Duration46 weeks
ComparatorPlacebo
Primary endpoint / questionPercent body-weight change
Safety resultGI adverse events were frequent and were a major tolerability limitation.
Key limitationsPhase 2 size/duration; dose escalation and discontinuations affect estimands; no long-term outcomes.
Registry / identifierPhase 2 obesity trial
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