A Study of LY3938577 in Healthy Participants and Participants With Type 1 Diabetes Mellitus (T1DM)
← catalyst calendarNCT06280703 · readout ≤ 42 d
Sponsored by Eli Lilly and Company (industry) · LLY — their whole pipeline →.
Phase
Phase 1
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Basic science
Enrollment
118estimated
Sites
1
Country
Germany
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-05-15 | actual | When the study began enrolling |
| Primary completion | Sep 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Sep 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2024-02-28 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-01-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Healthy
- Type 1 Diabetes Mellitus
Interventions
- Drug: LY3938577
- Drug: Placebo
- Drug: Insulin Degludec
- Drug: Insulin Lispro
- Drug: LY3938577
- Drug: Placebo
- Drug: Insulin Degludec
- Drug: Basal Insulin
- Drug: Lispro Prandial Insulin
Primary outcomes
what the primary-completion date above is the date OFPart 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.
measured Baseline up to Approximately Week 11
Part B and D: 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.
measured Baseline up to Week 10
Part A: Number of Participants With Clinically Significant Changes in Vital Signs
measured Baseline up to Approximately Week 11
Part B: Number of Participants With Clinically Significant Changes in Vital Signs
measured Baseline up to Week 10
Part A: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
measured Baseline up to Approximately Week 11
Part B: Number of Participants With Clinically Significant Changes in Safety Laboratory Parameters
measured Baseline up to Week 10
Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
measured Predose on day 1 up to week 13 post dose
Part A: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
measured Predose on day 1 up to week 13 post dose
Part B: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
measured Predose on day 1 up to week 13 post dose
Part C: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
measured Predose on day 1 up to week 13 post dose
Part D: Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3938577
measured Predose on day 1 up to week 13 post dose
Part A: PK: Maximum Observed Concentration (Cmax) of LY3938577
measured Predose on day 1 up to week 13 post dose
Part B: PK: Maximum Observed Concentration (Cmax) of LY3938577
measured Predose on day 1 up to week 13 post dose
Part C: PK: Concentration of LY3938577
measured Predose on day 1 up to week 13 post dose
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