Overview

A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

Status:
Not yet recruiting
Trial end date:
2023-10-31
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Eli Lilly and Company
Treatments:
Dulaglutide
Criteria
Inclusion Criteria:

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

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

1. HbA1c >/= 7.0% to and participants treated with metformin alone, and

2. HbA1c >/= 6.0% to 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

Exclusion Criteria:

- Participants who have uncontrolled diabetes defined as an episode of ketoacidosis or
hyperosmolar state requiring hospitalization in the 6 months prior to screening

- Have a clinically significant abnormality ECG

- Have obesity induced by other endocrine disorders such as Cushing's syndrome or
Prader-Willi syndrome

- Are on any glucose-lowering medications other than metformin, SGLT-2 inhibitors and/or
DPP4

- Have received chronic systemic glucocorticoid therapy (>2 weeks) in the past 6 months

- Have an average weekly alcohol intake that exceeds 21 units per week (males 65 years
of age or lesser) and 14 units per week (females and males 65 years of age or older)

- Smoke more than 10 cigarettes, or cigarette equivalent, per day