Actively Recruiting
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
Led by Eli Lilly and Company · Updated on 2026-03-11
124
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and effects of LY4057996 in healthy adults and adults with Type 1 or Type 2 Diabetes. This Phase 1 study aims to understand how well the drug is tolerated and what side effects may occur. It also investigates how LY4057996 is absorbed and eliminated in the body through blood tests. The study is sponsored by Eli Lilly and Company and includes multiple parts with varying durations and participant groups. Participants will receive LY4057996 or placebo either subcutaneously (under the skin) or intravenously (into a vein). Some groups may also receive other insulin treatments such as basal insulin, Lispro, or Degludec. The study is divided into several parts: Part A lasts about 11 weeks, Parts A3 to A5 last about 4 weeks, Part B lasts about 6 weeks, and Part C lasts about 7 weeks, not including a screening period. Different parts include different dosing schedules and combinations of study drugs and insulin therapies. During the study, participants will undergo regular blood tests to measure drug levels and effects on glucose control. Researchers will monitor for any serious or related side effects throughout the study period, which can last up to 47 weeks. Other assessments include measuring fasting glucose and glucose infusion rates. Participants will be closely observed to ensure safety and to collect detailed information about how LY4057996 works in the body.
CONDITIONS
Brief Title
A Study of LY4057996 in Healthy Participants and Participants With Type 1 and Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Healthy participants confirmed by medical evaluation including physical exam and tests
- Participants with Type 2 Diabetes diagnosed more than 1 year before enrollment
- Type 2 Diabetes participants on basal insulin therapy (glargine, detemir, or degludec) using more than 10 units daily for at least 6 months (Cohort 5 only)
- HbA1c between 6.5% and 9.5% for Type 2 Diabetes participants at screening
- Participants with Type 1 Diabetes for at least 1 year with fasting C-peptide ≤0.20 nmol/L or non-fasting C-peptide ≤0.30 nmol/L
- HbA1c between 6% and 8.5% for Type 1 Diabetes participants at screening
- Blood pressure less than 140/90 mmHg if healthy or less than 150/90 mmHg if diabetic, with pulse rate under 90 bpm (supine)
- No hypoglycemia unawareness for all diabetic participants
You will not qualify if you...
- More than 1 emergency room visit or hospitalization due to poor glucose control in the past 6 months
- Any episodes of severe hypoglycemia or hypoglycemia unawareness within 6 months prior to screening
- Significant history of cardiovascular disease
- Presence of gastroparesis or history of gastric surgery
- Acute or chronic hepatitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 47 weeks
Participants receive LY4057996 or comparator drugs administered subcutaneously or intravenously according to their assigned cohort.
Multiple visits for dosing and monitoring over the treatment period
Trial Site Locations
Total: 1 location
1
Profil Institut für Stoffwechselforschung
Neuss, Germany, 41460
Actively Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
BASIC_SCIENCE
Number of Arms
6
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