LY3938577 first-in-human study (healthy adults and type 2 diabetes)
The study that first put Lilly's glucose-sensitive insulin into people, in healthy adults and adults with type 2 diabetes. Completed June 2024 with no posted results. It is the origin point of the current clinical programme and, like the rest of it, has disclosed nothing about whether the molecule's potency actually tracks glucose in humans.
Primary endpoints
- Part A: number of participants with one or more adverse events and serious adverse events
- Part B: number of participants with one or more adverse events and serious adverse events
- Part A: incidence of hypoglycemia
Results so far
None posted. Started 17 November 2023, completed 28 June 2024, 66 participants enrolled, United States sites. That the programme progressed to a T1D Phase 1 and a T2D Phase 2 is the only public read on how this study went.
The full picture
The first time a glucose-sensitive insulin from the current industry generation was given to a human being, in November 2023.
Population caveat first. Healthy adults and adults with type 2 diabetes. No participants with type 1 diabetes, so nothing here scores the glucose-responsive insulin record under this site's rule that Type 2 evidence never scores a Type 1 record.
One endpoint is worth noting. Incidence of hypoglycemia was a primary endpoint in Part A. For an ordinary insulin, hypoglycemia is a side effect to be counted. For a glucose-responsive insulin it is closer to a mechanism readout — the entire proposition is that lows should become harder to cause. Measuring it first-in-human is the right instinct; not publishing the number three years later is the recurring problem across this whole programme.
What can be inferred. Only the obvious: the programme continued. Lilly went on to open a Phase 1 in type 1 diabetes and a Phase 2 in type 2 diabetes. Companies do not usually advance molecules that failed safety. That is inference from behaviour, not evidence, and it is all the public record supports.