LY3938577 first-in-human study (healthy adults and type 2 diabetes): review notes

Assessment: Removed unsupported first-in-class/current-generation and inferred-safety claims. Healthy/T2D-only 66-person study with no posted results is development context, not T1D efficacy.

Registry: NCT06132126; COMPLETED; updated 2024-07-24; enrollment 66 (ACTUAL); results not posted.

Endpoint comparison: Part A: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration (Baseline up to 16 days); Part B: Number of participants with one or more Adverse Event (s) (AEs), and Serious Adverse Event(s) (SAEs) considered by the investigator to be related to study drug administration (Baseline up to 44 days); Part A: Incidence of Hypoglycemia (Baseline up to 16 days); Part B: Incidence of Hypoglycemia (Baseline up to 44 days); Part A: Number of Participants With Clinically Significant Changes in Vital Signs (Baseline up to 16 days); Part B: Number of Participants With Clinically Significant Changes in Vital Signs (Baseline up to 44 days); Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters (Baseline up to 16 days); Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters (Baseline up to 44 days).

Sources for this record: A Study to Investigate the Safety and Tolerability of LY3938577 in Healthy Participants and Participants With Type 2 Diabetes (registry).

Limits: Source access and review depth vary. Registry fields establish the registered study, not clinical benefit, product approval or current local access. Cited-source reachability alone was not treated as verification of its claims.