A Study of LY3532226 in Participants With Type 2 Diabetes Mellitus

NCT ID: NCT05407961

Last Updated: 2024-03-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-07
• Study Completion Date: 2024-01-12

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

LY3532226 + Dulaglutide (Part A)

LY3532226 administered subcutaneously (SC) followed by dulaglutide administered SC.

Group Type: EXPERIMENTAL

LY3532226

Intervention Type: DRUG

Administered SC.

Dulaglutide

Intervention Type: DRUG

Administered SC.

Placebo + Dulaglutide (Part A)

Placebo administered SC followed by dulaglutide administered SC.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC.

Dulaglutide

Intervention Type: DRUG

Administered SC.

Dulaglutide + Placebo (Part B)

Dulaglutide administered SC in combination with placebo given SC.

Group Type: ACTIVE_COMPARATOR

Placebo

Intervention Type: DRUG

Administered SC.

Dulaglutide

Intervention Type: DRUG

Administered SC.

LY3532226 + Dulaglutide (Part B)

LY3532226 administered SC in combination with Dulaglutide given SC.

Group Type: EXPERIMENTAL

LY3532226

Intervention Type: DRUG

Administered SC.

Dulaglutide

Intervention Type: DRUG

Administered SC.

LY3532226 + Placebo (Part B)

LY3532226 administered SC in combination with placebo given SC.

Group Type: EXPERIMENTAL

LY3532226

Intervention Type: DRUG

Administered SC.

Placebo

Intervention Type: DRUG

Administered SC.

Interventions

LY3532226

Administered SC.

Intervention Type: DRUG

Placebo

Administered SC.

Intervention Type: DRUG

Dulaglutide

Administered SC.

Intervention Type: DRUG

Other Intervention Names

Trulicity

Eligibility 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 </= 10.0% for participants treated with diet and exercise alone and participants treated with metformin alone, and

2. 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

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)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

Profil Institut für Stoffwechselforschung

Neuss, , Germany

Countries

Germany

Other Identifiers

2021-003257-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

J2V-MC-GZLB

Identifier Type: OTHER

Identifier Source: secondary_id

17835

Identifier Type: -

Identifier Source: org_study_id