Evaluating LY4057996 in Healthy Individuals and Those 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
This study is testing a new drug called LY4057996 to see how well it is tolerated and what side effects it might have in healthy people and those with Type 1 or Type 2 diabetes.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Locations | 1 site (Neuss) |
| Trial ID | NCT06945406 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the tolerance and side effects of LY4057996 in both healthy participants and those diagnosed with Type 1 and Type 2 Diabetes. Participants will receive the study drug either subcutaneously or intravenously, and blood tests will be conducted to measure the drug's absorption and elimination from the body. The study is structured into multiple parts, lasting between 4 to 11 weeks, depending on the participant group. The goal is to gather comprehensive data on the drug's safety profile and pharmacokinetics.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals and those with Type 1 or Type 2 Diabetes meeting specific criteria regarding their diabetes management and health status.
Not a fit: Patients with uncontrolled diabetes or those not meeting the specific inclusion criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for individuals with Type 1 and Type 2 Diabetes.
How similar studies have performed: Other studies have shown promise in evaluating similar interventions, but the specific approach of LY4057996 is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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 Exclusion Criteria: * 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
Where this trial is running
Neuss
- Profil Institut für Stoffwechselforschung — Neuss, Germany (Recruiting)
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.