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

• Sponsor: Eli Lilly and Company (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04143802
• Collaborator: (none)
• Enrollment: 72
• Locations: 4
• Arms: 3
• Actual Duration (Months): 12.4
• Patients Per Site: 18
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2	Drug: LY3437943; Drug: Dulaglutide; Drug: Placebo	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Basic Science
• Official Title: A Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3437943 in Patients With Type 2 Diabetes Mellitus
• Actual Study Start Date: Dec 18, 2019
• Actual Primary Completion Date: Dec 28, 2020
• Actual Study Completion Date: Dec 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: LY3437943 LY3437943 administered subcutaneously (SC)	Drug: LY3437943; Administered SC
Active Comparator: Dulaglutide Dulaglutide administered SC	Drug: Dulaglutide; Administered SC; Other Names: LY2189265
Placebo Comparator: Placebo Placebo administered SC	Drug: Placebo; Administered SC

Outcome Measures

Primary Outcome Measures

1. Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [Baseline through Day 106]

   A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3437943 [Baseline through study completion (12 weeks)]

   PK: AUC of LY3437943

2. PK: Maximum Concentration (Cmax) of LY3437943 [Baseline through study completion (12 weeks)]

   PK: Cmax of LY3437943

3. Change from Baseline in Mean Daily Plasma Glucose (PG) [Baseline through Day 80]

   Change from baseline in mean daily PG from 6-point PG profile

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anaheim Clinical Trials, LLC	Anaheim	California	United States	92801
2	Miami Research Associates	Miami	Florida	United States	33143
3	PRA International	Lenexa	Kansas	United States	66219
4	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229

Sponsors and Collaborators

• Eli Lilly and Company

Investigators

• Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

None provided.

• Responsible Party: Eli Lilly and Company
• ClinicalTrials.gov Identifier: NCT04143802
• Other Study ID Numbers: 17137; J1I-MC-GZBB
• First Posted: Oct 29, 2019
• Last Update Posted: Jan 20, 2021
• Last Verified: Jan 15, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Dulaglutide

Study Results

No Results Posted as of Jan 20, 2021