A Study of LY3493269 in Participants With Type 2 Diabetes

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-25

Study Completion Date

2021-03-09

Brief Summary

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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.

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1.5 milligrams (mg) Dulaglutide

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

Group Type ACTIVE_COMPARATOR

Dulaglutide

Intervention Type DRUG

Administered SC

0.3 mg LY3493269

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

Group Type EXPERIMENTAL

LY3493269

Intervention Type DRUG

Administered SC

1 mg LY3493269

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

Group Type EXPERIMENTAL

LY3493269

Intervention Type DRUG

Administered SC

0.75/1.5/3 mg LY3493269

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.

Group Type EXPERIMENTAL

LY3493269

Intervention Type DRUG

Administered SC

1.5/3/4/5 mg LY3493269

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.

Group Type EXPERIMENTAL

LY3493269

Intervention Type DRUG

Administered SC

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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LY3493269

Administered SC

Intervention Type DRUG

Dulaglutide

Administered SC

Intervention Type DRUG

Placebo

Administered SC

Intervention Type DRUG

Other Intervention Names

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LY2189265

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No