NCT06945406RecruitingPhase 1
A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes
A Phase 1 Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 29 Sept 2026
Brief summary (registry, in English)
The purpose of this study is to evaluate how well LY4057996 is tolerated and what side effects may occur in healthy participants and participants with Type 1 and Type 2 Diabetes. The study drug will be administered either subcutaneously (SC) (under the skin) or intravenously (IV) (into a vein in the arm). Blood tests will be performed to check how much LY4057996 gets into the bloodstream and how long it takes the body to eliminate it. The study will last 11 weeks for Part A1-A2, 4 weeks for A3-A5, 6 weeks for Part B and 7 weeks for Part C, all approximations, excluding a screening period.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 124 (estimated)
- First submitted
- 18 Apr 2025
- Start date
- 16 May 2025
- Primary completion date
- Mar 2027
- Lead sponsor
- Eli Lilly and Company
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT06945406
- EU CT number
- 2024-519151-28-00
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 124
- From 16 May 2025 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Have had any episodes of severe hypoglycemia (defined as requiring assistance due to neurologically disabling hypoglycemia), hypoglycemia unawareness, or both within the 6 months prior to screening
- All Parts
- Gastrointestinal: have gastroparesis or have undergone gastric surgery
Other illness
- Cardiovascular: no significant history of cardiovascular disease (CVD)
- Hepatic: have acute or chronic hepatitis
Lab values
- Have had more than 1 emergency room visit or hospitalization due to poor glucose control (hyperglycemia or diabetic ketoacidosis) within 6 months prior to screening
Who the study is looking for
- Part A for Healthy Participants:
- Are overtly healthy as determined by medical evaluation, including medical history, physical exam, laboratory tests, and cardiac screening assessment
- Part A for Type 2 Diabetes (T2DM) Participants:
- Are participants with T2DM diagnosed greater than 1 year before enrollment,
- On basal insulin therapy, insulin glargine, insulin detemir, or insulin degludec, greater than 10 units per day for at least 6 months (for Cohort 5 only)
- Glycated hemoglobin (HbA1c) 6.5% to 9.5% inclusive at screening
- Part B
- Have Type 1 Diabetes (T1D) for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening
- HbA1c 6% to 8.5% inclusive at screening
- Part C
- Have T1D for at least 1 year with a fasting C-peptide level of 0.20 nanomole per liter (nmol/L) or less or non-fasting C-peptide level of 0.30 nmol/L or less at screening
- HbA1c 6 to 8.5% inclusive at screening
- All Parts
- Have blood pressure of less than 140/90 millimeters of mercury (mmHg) for healthy participants or 150/90 mmHg for participants with diabetes and pulse rate of less than 90 beats per minute (bpm) (supine)
- No hypoglycemia unawareness for all Type 1 and Type 2 Diabetes participants
Age in the registry: 18 years to 64 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| PROFIL Institut fuer Stoffwechselforschung GmbH Coordinator of this site? Confirm its status | Neuss | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.