A Study of LY3493269 in Participants With Type 2 Diabetes

Lilly

Status and phase: Completed; Phase 1

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Placebo; Drug: Dulaglutide; Drug: LY3493269

Study type: Interventional

Funder types: Industry

Identifiers

NCT04515576

17530

J1X-MC-GZHC (Other Identifier)

Details and patient eligibility

About

The main purpose of this study is to determine the side effects related to LY3493269 in participants with type 2 diabetes. Blood tests will be performed to check concentrations of LY3493269 in the bloodstream. Each enrolled participant will receive LY3493269, dulaglutide, or placebo. The study will last up to approximately 16 weeks for each participant and may include up to 11 visits.

Enrollment: 56 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are male or female not of childbearing potential
• Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive, at screening
• Have had a stable body weight (<5% body weight change) for the 3 months prior to screening
• Have not modified their diet or adopted any nutritional lifestyle modification in the 3 months prior to screening
• Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are on a stable dose of metformin for at least 3 months before screening. Patients with comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) may be eligible for inclusion if conditions are assessed by the investigator to be well controlled and stable for at least 3 months prior to screening
• Have an HbA1c of at least 7.0% and no more than 10.5% at screening
• Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator

Exclusion criteria

• Have type 1 diabetes mellitus or latent autoimmune diabetes in adults
• Have uncontrolled diabetes, defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening
• Have a history of proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy that requires acute treatment
• Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
• Have a definitive diagnosis of autonomic neuropathy as evidenced by urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea
• Have a history of acute or chronic pancreatitis
• Have a self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma
• Have calcitonin levels of 20 picograms per millilitre (pg/mL) or more at screening

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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56 participants in 6 patient groups, including a placebo group

1.5 milligrams (mg) Dulaglutide

Active Comparator group

Description:

Participants received 1.5 mg dulaglutide subcutaneously (SC) once weekly (QW) for 4 weeks.

Treatment:

Drug: Dulaglutide

0.3 mg LY3493269

Experimental group

Description:

Participants received 4 fixed dosed of 0.3 mg LY3493269 SC QW for 4 weeks.

Treatment:

Drug: LY3493269

1 mg LY3493269

Experimental group

Description:

Participants received 4 fixed dosed of 1 mg LY3493269 SC QW for 4 weeks.

Treatment:

Drug: LY3493269

0.75/1.5/3 mg LY3493269

Experimental group

Description:

Participants received LY3493269 0.75 mg on week 1, 1.5 mg on week 2 and 3 mg on week 3 and 4 SC as weekly doses.

Treatment:

Drug: LY3493269

1.5/3/4/5 mg LY3493269

Experimental group

Description:

Participants received LY3493269 1.5 mg on week 1, 3 mg on week 2, 4 mg on week 3 and 5 mg on week 4 as weekly doses.

Treatment:

Drug: LY3493269

Placebo

Placebo Comparator group

Description:

Participants received placebo subcutaneously (SC) once weekly (QW) for 4 weeks.

Treatment:

Drug: Placebo