Phase 1 study of LY4057996 (SC and IV) vs insulin degludec and lispro in healthy, T1D, and T2D participants
What this study tests
A multi-part phase 1 trial in Germany evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of investigational Eli Lilly compound LY4057996 (subcutaneous and intravenous) compared with placebo, insulin degludec, and insulin lispro across healthy volunteers, T2D, and T1D cohorts.
Editorial review: .
Registry checked: 2026-10-19. Registry’s own update: 2026-09-29.
Most recent recorded citation date: 2026-09-29. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Adults aged 18 years and older across healthy volunteer, type 2 diabetes, and type 1 diabetes cohorts. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- No results posted. Registry checked 19 October 2026 (ClinicalTrials.gov last update 29 September 2026): recruiting in Germany; estimated n=124 across all cohorts; estimated primary completion March 2027.Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: European Union. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
Primary endpoints
- Number of participants with one or more treatment-related serious adverse events (SAEs) and adverse events (AEs) up to 47 weeks
The full picture
What the study asks
NCT06945406 is a multi-part phase 1 clinical trial conducted in Germany evaluating Eli Lilly's investigational insulin candidate LY4057996, administered subcutaneously and intravenously, against placebo, insulin degludec, and insulin lispro in healthy participants and adults with type 1 or type 2 diabetes.1
Who it involves
Adults aged 18 years and older enrolled into distinct healthy volunteer, type 2 diabetes, and type 1 diabetes cohorts.1
Design and timing
The registry lists an actual start date of 16 May 2025, an estimated total enrollment of 124 participants across all cohorts, and an estimated primary and study completion in March 2027. The primary endpoint tracks treatment-related adverse events and serious adverse events up to 47 weeks.1
Evidence and limits
No results are posted, and the public registry entry does not disclose the molecular structure or glucose-responsiveness mechanism of LY4057996. Early phase 1 safety and clamp testing across mixed cohorts does not establish clinical efficacy in type 1 diabetes.1
Sources
- [1]A Phase 1 Study of LY4057996 in Healthy Participants and Participants With Type 1 or Type 2 Diabetes Mellitus (NCT06945406) · Trial registry · 2026-09-29 — Protocol and current registry status checked 19 October 2026: RECRUITING; estimated n=124; actual start 16 May 2025; last update posted 29 September 2026; no results posted.
ClinicalTrials.gov. NCT06945406. Record checked 19 October 2026; first posted 2025-04-25; last update posted 2026-09-29.