Human evidence record · Zenagamtide

Once-daily oral zenagamtide in type 2 diabetes

HbA1c fell by about 0.9%, 1.3% and 1.4% across the three active dose groups, significantly more than 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=186

What happened?

HbA1c fell by about 0.9%, 1.3% and 1.4% across the three active dose groups, significantly more than placebo.

What stops us overclaiming?

Phase II and formulation-specific; oral and injectable regimens are not interchangeable.

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Key result

HbA1c fell by about 0.9%, 1.3% and 1.4% across the three active dose groups, significantly more than 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 size186

RouteOral

Regimen / exposure6, 25 or 50 mg once daily after escalation from 1.5 mg

Duration36 weeks + 4-week follow-up

ComparatorPlacebo

Primary endpoint / questionChange in HbA1c

Safety resultGI adverse events occurred in 26%, 41% and 47% across active groups versus 23% placebo; no deaths occurred.

Key limitationsPhase II and formulation-specific; oral and injectable regimens are not interchangeable.

Registry / identifierPMID 42532079 / NCT06542874

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