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

Phase 1

Active, not recruiting

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Drug: LY3209590

• Registration Number: NCT06169982
• Lead Sponsor: Eli Lilly and Company

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-06
• Study First Submitted QC: 2023-12-06
• Study Start: 2023-12-07
• Study First Posted: 2023-12-14
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-18
• Last Update Posted: 2024-04-19
• Primary Completion: 2024-07-20
• Study Completion: 2024-07-20

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LY3209590	LY3209590	LY3209590 administered subcutaneously (SC)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Profil Institut für Stoffwechselforschung; 🇩🇪 Neuss, Nordrhein-Westfalen, Germany