WhichPepsPeptides. Without the hype.
Human evidence record ยท Sobetirome

Historical sobetirome Phase I single- and multiple-dose study (reported in peer-reviewed reviews)

Peer-reviewed reviews report LDL-C reductions up to 22% after single-dose exposure and up to 41% after the two-week multiple-dose phase.

Quick read
Historical human evidence reported in review

What this study tells us

This record summarizes a historical randomized Phase I study as reported in later peer-reviewed reviews. The primary full clinical report was not located, so the result is useful context but not equivalent to direct inspection of the original trial publication.

Who was studied?

Adult participants

How many?

n=32 single-dose; 24 multiple-dose

What happened?

Peer-reviewed reviews report LDL-C reductions up to 22% after single-dose exposure and up to 41% after the two-week multiple-dose phase.

What stops us overclaiming?

Primary full clinical report was not located; the result is described in later peer-reviewed reviews and historical meeting reporting. Long-term outcomes are unknown.

Need help with terms such as randomized, placebo, endpoint or sample size? Open the glossary โ†’

Key result

Peer-reviewed reviews report LDL-C reductions up to 22% after single-dose exposure and up to 41% after the two-week multiple-dose phase.

Study details

Study designRandomized, double-blind, placebo-controlled early clinical study as reported in reviews
PhasePhase I
PopulationAdult participants
Sample size32 single-dose; 24 multiple-dose
RouteOral
Regimen / exposureSingle ascending doses; repeated dosing for two weeks
DurationUp to 2 weeks
ComparatorPlacebo
Primary endpoint / questionLipid lowering and short-term tolerability
Safety resultReviews report no obvious extrahepatic effects during the short exposure.
Key limitationsPrimary full clinical report was not located; the result is described in later peer-reviewed reviews and historical meeting reporting. Long-term outcomes are unknown.
Registry / identifierHistorical Phase I; secondary peer-reviewed source