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Human evidence record · Sobetirome

Sobetirome Phase I development summary

Peer-reviewed development reviews report Phase I human exposure and LDL-lowering pharmacology, with the programme not progressing to an approved therapy.

Quick read
Historical human evidence reported in review

What this study tells us

This record relies on a peer-reviewed development review describing historical Phase I human exposure. The primary full trial publication was not located in this evidence pass, so numeric claims should be read as secondary reporting rather than direct primary-trial extraction.

Who was studied?

Healthy volunteers / early lipid-development population

How many?

n=24

What happened?

Peer-reviewed development reviews report Phase I human exposure and LDL-lowering pharmacology, with the programme not progressing to an approved therapy.

What stops us overclaiming?

Primary full trial publication was not located in this pass; numeric regimen/outcome details rely on secondary development summaries.

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Key result

Peer-reviewed development reviews report Phase I human exposure and LDL-lowering pharmacology, with the programme not progressing to an approved therapy.

Study details

Study designPhase I human development programme summarized in peer-reviewed review
PhasePhase I
PopulationHealthy volunteers / early lipid-development population
Sample size24
RouteOral
Regimen / exposureMultiple once-daily dose cohorts for 14 days; secondary summaries report doses up to 100 micrograms/day
Duration14 days
ComparatorPlacebo / dose cohorts
Primary endpoint / questionLipid effects and tolerability
Safety resultNo obvious major safety signal was highlighted in the development review, but the trial was small and short.
Key limitationsPrimary full trial publication was not located in this pass; numeric regimen/outcome details rely on secondary development summaries.
Registry / identifierPMID 26565124