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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943 in Patients With Type 2 Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04143802
• Other study ID #: 17137
• Secondary ID: J1I-MC-GZBB
• Status: Completed
• Phase: Phase 1
• Start date: December 18, 2019
• Est. completion date: December 28, 2020

Study information

• Verified date: January 15, 2021
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 28, 2020
• Est. primary completion date: December 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• LY3437943
Administered SC
• Dulaglutide
Administered SC
• Placebo
Administered SC

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Day 106
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3437943	PK: AUC of LY3437943	Baseline through study completion (12 weeks)
Secondary	PK: Maximum Concentration (Cmax) of LY3437943	PK: Cmax of LY3437943	Baseline through study completion (12 weeks)
Secondary	Change from Baseline in Mean Daily Plasma Glucose (PG)	Change from baseline in mean daily PG from 6-point PG profile	Baseline through Day 80

External Links

•   Related Info