Human evidence record · Zenagamtide

Once-weekly subcutaneous zenagamtide in type 2 diabetes

HbA1c change ranged from -0.9% at 0.4 mg to -1.7% at 40 mg; all active groups showed significant improvement versus 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 on metformin with or without SGLT2 inhibitor

How many?

n=262

What happened?

HbA1c change ranged from -0.9% at 0.4 mg to -1.7% at 40 mg; all active groups showed significant improvement versus placebo.

What stops us overclaiming?

Phase II, dose-ranging and diabetes-specific; longer-term outcomes remain investigational.

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Key result

HbA1c change ranged from -0.9% at 0.4 mg to -1.7% at 40 mg; all active groups showed significant improvement versus placebo.

Study details

Study designRandomized, double-blind, placebo-controlled dose-finding trial

PhasePhase II

PopulationAdults with type 2 diabetes on metformin with or without SGLT2 inhibitor

Sample size262

RouteSubcutaneous

Regimen / exposure0.4, 1.5, 5, 10, 20 or 40 mg once weekly after escalation from 0.2 mg

Duration36 weeks + 4-week follow-up

ComparatorPlacebo

Primary endpoint / questionChange in HbA1c

Safety resultMost adverse events were GI and mild-to-moderate; 21/261 exposed participants had serious adverse events, with no deaths.

Key limitationsPhase II, dose-ranging and diabetes-specific; longer-term outcomes remain investigational.

Registry / identifierPMID 42532080 / NCT06542874

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