Diabetes Mellitus, Type 1Phase 1YKAANCT06945406
A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes
A Phase 1 study testing LY4057996 SC, LY4057996 IV and Degludec SC in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Eli Lilly and Company at 1 site in Germany.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
- What is being tested?
- LY4057996 SC, LY4057996 IV and Degludec SC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 1 siteGermany
- Study dates
- 16 May 2025to Mar 2027
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
- 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
- Cardiovascular: no significant history of cardiovascular disease (CVD)
- Gastrointestinal: have gastroparesis or have undergone gastric surgery
- Hepatic: have acute or chronic hepatitis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or contact
Physicians interested in becoming principal investigators please contact contact
Germany1 site, 1 recruiting
- Recruiting
Profil Institut für Stoffwechselforschung
Neuss, 41460
+49 (0) 2131 4018 180
Oliver Klein
About this study
Official title: 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
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.
- Being tested
- LY4057996 SC, LY4057996 IV, Placebo SC, Placebo IV, Degludec SC
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY4057996 SCDrug
Administered SC
LY4057996 IVDrug
Administered IV
Placebo SCDrug
Administered SC
Placebo IVDrug
Administered IV
Degludec SCDrug
Administered SC
Lispro SCDrug
Administered SC
Degludec IVDrug
Administered IV
Pre-study basal insulin SCDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| LY4057996 Part A (Cohorts A1-A5) | Experimental | LY4057996 administered subcutaneously (SC) and/or intravenously (IV) Receives: Drug: LY4057996 SC; Drug: LY4057996 IV |
| Placebo Part A (Cohort A1-A5) | Placebo comparator | Placebo administered SC and/or IV Receives: Drug: Placebo SC; Drug: Placebo IV |
| LY4057996 Part B | Experimental | LY4057996 administered SC Receives: Drug: LY4057996 SC |
| LY4057996 Part C | Experimental | LY4057996 and interventions of pre-study basal insulin and Lispro administered SC Receives: Drug: LY4057996 SC; Drug: Lispro SC; Drug: Pre-study basal insulin SC |
| Degludec Part A (Cohort A2-A5) | Active comparator | Degludec administered SC and/or IV Receives: Drug: Degludec SC; Drug: Degludec IV |
| Degludec Part B | Active comparator | Degludec administered SC Receives: Drug: Degludec SC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with One or More Serious Adverse Event(s) (SAEs) and Adverse Event(s) (AEs) Considered by the Investigator to be Related to Study Drug Administration
A summary of SAEs and AEs regardless of causality, will be reported in the Reported Adverse Events module
Measured: Baseline to Study Completion (Up to 47 Weeks)
Secondary outcomes (4)
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY4057996
PK: AUC of LY4057996
Measured: Baseline to Study Completion (Up to 47 Weeks)
PK: Maximum Concentration (Cmax) of LY4057996
PK: Cmax of LY4057996
Measured: Baseline to Study Completion (Up to 47 Weeks)
Pharmacodynamic (PD): Change from Baseline in Fasting Glucose
PD: Change from Baseline in Fasting Glucose
Measured: Baseline to Study Completion (Up to 47 Weeks)
PD: AUC of Glucose Infusion Rate (GIR)
PD: AUC of GIR
Measured: Baseline Up to 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2025
- Study start16 May 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Parts A and C are sequential: Parts B and C are crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06945406
- Sponsor's protocol ID
- 27329
- Other IDs
- 2024-519151-28-00, J6B-MC-YKAA
- Acronym
- YKAA
- Status last verified
- Sep 2026
- First submitted
- 18 Apr 2025
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No