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

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LY3437943

Dulaglutide

Placebo

About this trial

This is an interventional basic science trial for Diabetes Mellitus, Type 2

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Anaheim Clinical Trials, LLC
Miami Research Associates
PRA International
Clinical Trials of Texas, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

LY3437943

Dulaglutide

Placebo

Arm Description

LY3437943 administered subcutaneously (SC)

Dulaglutide administered SC

Placebo administered SC

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3437943

PK: AUC of LY3437943

PK: Maximum Concentration (Cmax) of LY3437943

PK: Cmax of LY3437943

Change from Baseline in Mean Daily Plasma Glucose (PG)

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

Full Information

NCT ID

NCT04143802

First Posted

October 28, 2019

Last Updated

January 18, 2021

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT04143802

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 15, 2021

Overall Recruitment Status

Completed

Study Start Date

December 18, 2019 (Actual)

Primary Completion Date

December 28, 2020 (Actual)

Study Completion Date

December 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY3437943

Arm Type

Experimental

Arm Description

LY3437943 administered subcutaneously (SC)

Arm Title

Dulaglutide

Arm Type

Active Comparator

Arm Description

Dulaglutide administered SC

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo administered SC

Intervention Type

Drug

Intervention Name(s)

LY3437943

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Dulaglutide

Other Intervention Name(s)

LY2189265

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Description

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

Time Frame

Baseline through Day 106

Secondary Outcome Measure Information:

Title

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of LY3437943

Description

PK: AUC of LY3437943

Time Frame

Baseline through study completion (12 weeks)

Title

PK: Maximum Concentration (Cmax) of LY3437943

Description

PK: Cmax of LY3437943

Time Frame

Baseline through study completion (12 weeks)

Title

Change from Baseline in Mean Daily Plasma Glucose (PG)

Description

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

Time Frame

Baseline through Day 80

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Anaheim Clinical Trials, LLC

City

Anaheim

State/Province

California

ZIP/Postal Code

92801

Country

United States

Facility Name

Miami Research Associates

City

Miami

State/Province

Florida

ZIP/Postal Code

33143

Country

United States

Facility Name

PRA International

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66219

Country

United States

Facility Name

Clinical Trials of Texas, Inc.

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

36354040

Citation

Urva S, Coskun T, Loh MT, Du Y, Thomas MK, Gurbuz S, Haupt A, Benson CT, Hernandez-Illas M, D'Alessio DA, Milicevic Z. LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial. Lancet. 2022 Nov 26;400(10366):1869-1881. doi: 10.1016/S0140-6736(22)02033-5. Epub 2022 Oct 27.

Results Reference

derived

Links:

URL

https://www.lillytrialguide.com/en-US/studies/adult-type-2-diabetes/GZBB#?postal=

Description

Related Info

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

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