NCT06169982Active, not recruitingPhase 1
A Phase 1, Open-Label, Multiple-Dose Study to Investigate Steady-State Pharmacokinetics and Pharmacodynamics During a Euglycemic Clamp of LY3209590 in Participants With Type 2 Diabetes Mellitus
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Eli Lilly and Company
- Enrollment
- 70
- Locations
- 1
- Primary Endpoint
- Pharmacokinetics (PK): Area under the concentration curve during one dosing interval at steady state (AUCss) of LY3209590
Study Overview
Brief Summary
The purpose of this study is to measure the activity and insulin time action of LY3209590 at steady state in participants with type 2 diabetes mellitus. The total study duration is approximately 182 days.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants with Type 2 Diabetes (T2DM).
- •Participants who are insulin naive or receiving basal insulin [NPH (neutral protamine Hagedorn) once or twice daily, once-daily insulin glargine U100 or U300, once-daily insulin degludec, or insulin detemir once or twice daily] for fewer than 5 years prior to screening.
- •Have glycated hemoglobin (HbA1c) of ≥7.0 percent (%) to ≤9.5%, HbA1c of ≥6.5% to ≤9.5% for participants on treatment with sulfonylureas and/or Sodium-Glucose Transport Protein 2 inhibitors who require washout.
- •Have a body mass index between 27 and 40 kilograms per meter square.
- •Male or female participants who are willing to comply with the contraception requirements consistent with local regulations.
- •Be willing to allow blood sample collection, reliable and to be available for the duration of the study as required for the study protocol.
Exclusion Criteria
- •Have known or suspected allergic reactions to study drugs, related compounds, excipients, and devices used in the study.
- •Have a specific type of diabetes other than T2DM.
- •Have known hemoglobinopathy, hemolytic anemia or sickle cell anemia, or any other traits of hemoglobin abnormalities known to interfere with the measurement of HbA1c.
- •Participants with a history of kidney complications.
Arms & Interventions
LY3209590
Experimental
LY3209590 administered subcutaneously (SC)
Intervention: LY3209590 (Drug)
Outcomes
Primary Outcomes
Pharmacokinetics (PK): Area under the concentration curve during one dosing interval at steady state (AUCss) of LY3209590
Time Frame: One dosing interval at steady state from 0 to 168 hours after last dose
PK: AUCss of LY3209590
Secondary Outcomes
- PK: Total amount of glucose infused during one dosing interval at steady state (Gtot,SS) of LY3209590(One dosing interval at steady state from 0 to 168 hours after last dose)
Investigators
Study Sites (1)
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