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

NCT06169982 | Completed Phase 1 FDA Drug

• 3 other identifiers: 18811I8H-MC-BDDG2023-508008-39-00
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Clamp; Diabetes, Type 2

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics (PK): Area under the concentration curve during one dosing interval at steady state (AUCss) of LY3209590

  PK: AUCss of LY3209590

  One dosing interval at steady state from 0 to 168 hours after last dose

Secondary Outcomes (1)

• 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

Study Arms (1)

LY3209590

EXPERIMENTAL

LY3209590 administered subcutaneously (SC)

Drug: LY3209590

Interventions

LY3209590 DRUG

Administered SC

LY3209590

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Profil Institut für Stoffwechselforschung

Neuss, North Rhine-Westphalia, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

  Eli Lilly and Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2023
• First Posted: December 14, 2023
• Study Start: December 7, 2023
• Primary Completion: July 18, 2024
• Study Completion: July 18, 2024
• Last Updated: September 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)