A Multiple Dose Study of LY3209590 in Participants With Type 2 Diabetes

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06169982

Enrollment

Registered

2023-12-14

Start date

2023-12-07

Completion date

2024-07-18

Last updated

2024-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 2

Keywords

Clamp, Diabetes, Type 2

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.

Interventions

DRUGLY3209590

Administered SC

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 74 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Pharmacokinetics (PK): Area under the concentration curve during one dosing interval at steady state (AUCss) of LY3209590	One dosing interval at steady state from 0 to 168 hours after last dose	PK: AUCss of LY3209590

Secondary

Measure	Time frame	Description
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	PK: Gtot,SS of LY3209590

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026