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

Completed · Phase 1 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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.

Key facts

Study ID: NCT04143802
Run by: Eli Lilly and Company
People needed: 72
Starts: 2019-12-18
Expected to finish: 2020-12-28
Last updated by the study team: 2021-01-20

Who can join

Age: 20 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Anaheim Clinical Trials, LLC — Anaheim, California, United States
Miami Research Associates — Miami, Florida, United States
PRA International — Lenexa, Kansas, United States
Clinical Trials of Texas, Inc. — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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