A Phase 1b, 2-Part, Investigator- and Participant-Blind, Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY3532226 in Participants With Type 2 Diabetes Mellitus

Status: Completed
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it. This is a 2-part study and will last approximately 16 weeks excluding screening period for each part, respectively.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:

• Participants with type 2 diabetes mellitus (T2DM) for at least 3 months before screening

• Have the following glycosylated hemoglobin (HbA1c) levels at screening:

‣ HbA1c \>/= 7.0% to \</= 10.0% for participants treated with diet and exercise alone and participants treated with metformin alone, and

⁃ HbA1c \>/= 6.0% to \</= 9.5% for participants treated with dipeptidyl peptidase inhibitor-4 (DPP-4) (with/without metformin) inhibitors and participants treated with metformin and sodium-glucose cotransporter-2 (SGLT-2) inhibitor

• Participants treated with diet and exercise alone or on a stable dose of metformin for at least 3 months

• Participants with body weight up to 150 kilograms (kg) and body mass index (BMI) of 23.0 to 45.0 kilograms per meter squared (kg/m²)

• Male participants who agree to use effective methods of contraception and female participants not of childbearing potential

Locations
Other Locations
Germany
Profil Institut für Stoffwechselforschung
Neuss
Time Frame
Start Date: 2022-06-07
Completion Date: 2024-01-12
Participants
Target number of participants: 90
Treatments
Experimental: LY3532226 + Dulaglutide (Part A)
LY3532226 administered subcutaneously (SC) followed by dulaglutide administered SC.
Placebo_comparator: Placebo + Dulaglutide (Part A)
Placebo administered SC followed by dulaglutide administered SC.
Active_comparator: Dulaglutide + Placebo (Part B)
Dulaglutide administered SC in combination with placebo given SC.
Experimental: LY3532226 + Dulaglutide (Part B)
LY3532226 administered SC in combination with Dulaglutide given SC.
Experimental: LY3532226 + Placebo (Part B)
LY3532226 administered SC in combination with placebo given SC.
Authors
Theresa Herbrand
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov

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