A Study of LY2605541 and Insulin Lispro Mixture in Healthy Participants
Status and phase
Completed
Phase 1
Conditions
Healthy Volunteers
Treatments
Drug: Insulin Lispro
Drug: LY2605541
Study type
Interventional
Funder types
Industry
Identifiers
Details and patient eligibility
About
The main purpose of this study is to evaluate how the body absorbs and removes LY2605541, insulin lispro, and a mixture of both from the blood. The study has two parts. Participants may enroll in only one part. Each part has four treatment periods in a fixed order. The study will last approximately 8 weeks, not including screening. Screening is required within 28 days prior to the start of the study.
Enrollment
40 estimated patients
Sex
All
Ages
21 to 65 years old
Volunteers
Accepts Healthy Volunteers
Inclusion criteria
- Are not of child-bearing potential
- Have a body mass index (BMI) between 18 and 29.9 kilograms per meter squared (kg/m^2), inclusive
- Are nonsmokers or have not smoked for at least 2 months prior to entering the study
Exclusion criteria
- Have known allergies to insulin or its excipients, or related drugs, or history of relevant allergic reactions of any origin
- Have a history of first-degree relatives known to have diabetes mellitus
- Have used systemic glucocorticoids within 3 months prior to entry into the study
- Have donated blood or had a blood loss of 450 milliliter (mL) within 1 month prior to study enrollment
Trial design
Primary purpose
Basic Science
Allocation
Non-Randomized
Interventional model
Single Group Assignment
Masking
None (Open label)
40 participants in 8 patient groups
LY2605541-Part A
Experimental group
Description:
1.42 units per kilogram (U/kg) of LY2605541 given once daily (QD) for 1 day, subcutaneously (SQ) in 1 of 4 treatment periods.
Treatment:
Drug: LY2605541
Insulin Lispro-Part A
Active Comparator group
Description:
Single dose 0.36 U/kg of insulin lispro given QD for 1 day, SQ in 1 of 4 treatment periods.
Treatment:
Drug: Insulin Lispro
LY2605541/Lispro Mix 1-Part A
Experimental group
Description:
Single dose 0.54 U/kg of LY2605541 and 0.36 U/kg insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.
Treatment:
Drug: LY2605541
Drug: Insulin Lispro
LY2605541/Lispro Mix 2-Part A
Experimental group
Description:
Single dose 1.42 U/kg of LY2605541 and 0.36 insulin lispro mixture given QD for 1 day, SQ in 1 of 4 treatment periods.
Treatment:
Drug: LY2605541
Drug: Insulin Lispro
Insulin Lispro-Part B
Active Comparator group
Description:
0.18 U/kg insulin lispro given twice daily (BID) for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.
Treatment:
Drug: Insulin Lispro
LY2605541/Lispro Mix-Part B
Experimental group
Description:
0.71 U/kg LY2605541 and 0.18 U/kg insulin lispro mixture given BID for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.
Treatment:
Drug: LY2605541
Drug: Insulin Lispro
LY2605541 QD-Part B
Experimental group
Description:
0.54 U/kg of LY2605541 given QD for 1 day, SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.
Treatment:
Drug: LY2605541
LY2605541 BID-Part B
Experimental group
Description:
0.71 U/kg of LY2605541 given BID for 1 day SQ in 1 of 4 treatment periods. Part B is contingent on data from Part A.
Treatment:
Drug: LY2605541
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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