A Study of LY3437943 in Participants With Type 2 Diabetes Mellitus (T2DM)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-12-18

Study Completion Date

2020-12-28

Brief Summary

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The main purpose of this study is to learn about the side effects of LY3437943 when given to participants with type 2 diabetes. Blood tests will be performed to investigate how the body processes the study drug and how the study drug affects the body. Each enrolled participant will receive injections of LY3437943, dulaglutide, or placebo given just under the skin. For each participant, the study will last up to about 5 months and will include 16 visits to the study center.

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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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LY3437943

LY3437943 administered subcutaneously (SC)

Group Type EXPERIMENTAL

LY3437943

Intervention Type DRUG

Administered SC

Dulaglutide

Dulaglutide administered SC

Group Type ACTIVE_COMPARATOR

Dulaglutide

Intervention Type DRUG

Administered SC

Placebo

Placebo administered SC

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered SC

Interventions

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LY3437943

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

* Have T2DM for at least 3 months before screening and are without advanced known possible complications of diabetes mellitus
* Have a glycated hemoglobin (HbA1c) value at lead-in and screening of ≥7.0% and ≤10.5% and treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening
* Have had a stable body weight for the 3 months prior to randomization (\<5% body weight change)
* Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive
* Male participants agree to use an effective method of contraception for the duration of the study plus 90 days, which corresponds to 4 months after the last investigational product dose
* Women not of childbearing potential may participate and include those who are: infertile due to surgical sterilization (hysterectomy, bilateral oophorectomy, or tubal ligation), congenital anomaly such as mullerian agenesis; or those who are postmenopausal

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 known clinically significant gastric emptying abnormality
* Have had an episode of severe hypoglycemia
* Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of \>500 milligrams per deciliter (mg/dL) at screening and/or Day-2. If participant is on lipid-lowering therapies, doses must be stable for 30 days prior to screening
* Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase \[ALT\] and aspartate aminotransferase \[AST\]) greater than 3X upper limit of normal (ULN) at screening and/or Day -2

Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No