Back to results

A Study of LY3493269 in Participants With Type 2 Diabetes

Primary Purpose

Diabetes Mellitus, Type 2

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

LY3493269

Dulaglutide

Placebo

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Are male or female not of childbearing potential
Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive, at screening
Have had a stable body weight (<5% body weight change) for the 3 months prior to screening
Have not modified their diet or adopted any nutritional lifestyle modification in the 3 months prior to screening
Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are on a stable dose of metformin for at least 3 months before screening. Patients with comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) may be eligible for inclusion if conditions are assessed by the investigator to be well controlled and stable for at least 3 months prior to screening
Have an HbA1c of at least 7.0% and no more than 10.5% at screening
Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator

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 history of proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy that requires acute treatment
Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
Have a definitive diagnosis of autonomic neuropathy as evidenced by urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea
Have a history of acute or chronic pancreatitis
Have a self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma
Have calcitonin levels of 20 picograms per millilitre (pg/mL) or more at screening

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

LY3493269

Dulaglutide

Placebo

Arm Description

LY3493269 administered Subcutaneous (SC).

Dulaglutide administered SC.

Placebo administered SC.

Outcomes

Primary Outcome Measures

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

A summary of SAEs, TEAEs 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 (AUC) of LY3493269

PK: AUC of LY3493269

PK: Maximum Concentration (Cmax) of LY3493269

PK: Cmax of LY3493269

Pharmacodynamics (PD):Change from baseline to Day 29 in Fasting Glucose (FG)

Full Information

NCT ID

NCT04515576

First Posted

August 14, 2020

Last Updated

April 4, 2022

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT04515576

Brief Title

A Study of LY3493269 in Participants With Type 2 Diabetes

Official Title

Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Subcutaneous Doses of LY3493269 in Patients With Type 2 Diabetes Mellitus

Study Type

Interventional

2. Study Status

Record Verification Date

April 2022

Overall Recruitment Status

Completed

Study Start Date

August 25, 2020 (Actual)

Primary Completion Date

March 9, 2021 (Actual)

Study Completion Date

March 9, 2021 (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 determine the side effects related to LY3493269 in participants with type 2 diabetes. Blood tests will be performed to check concentrations of LY3493269 in the bloodstream. Each enrolled participant will receive LY3493269, dulaglutide, or placebo. The study will last up to approximately 16 weeks for each participant and may include up to 11 visits.

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

56 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LY3493269

Arm Type

Experimental

Arm Description

LY3493269 administered Subcutaneous (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)

LY3493269

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 Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Description

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

Time Frame

Baseline through final follow-up at Day 57

Secondary Outcome Measure Information:

Title

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3493269

Description

PK: AUC of LY3493269

Time Frame

Baseline through final follow-up at Day 57

Title

PK: Maximum Concentration (Cmax) of LY3493269

Description

PK: Cmax of LY3493269

Time Frame

Baseline through final follow-up at Day 57

Title

Pharmacodynamics (PD):Change from baseline to Day 29 in Fasting Glucose (FG)

Time Frame

Baseline, Day 29

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Are male or female not of childbearing potential Have a body mass index of 23 to 50 kilograms per square meter (kg/m²), inclusive, at screening Have had a stable body weight (<5% body weight change) for the 3 months prior to screening Have not modified their diet or adopted any nutritional lifestyle modification in the 3 months prior to screening Have type 2 diabetes mellitus (T2DM) controlled with diet and exercise alone or are on a stable dose of metformin for at least 3 months before screening. Patients with comorbid conditions commonly associated with diabetes (for example, hypertension, hypercholesterolemia, hypothyroidism) may be eligible for inclusion if conditions are assessed by the investigator to be well controlled and stable for at least 3 months prior to screening Have an HbA1c of at least 7.0% and no more than 10.5% at screening Have clinical laboratory test results within the normal range for the population or investigative site, or with abnormalities deemed not clinically significant by the investigator 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 history of proliferative diabetic retinopathy, diabetic maculopathy, or severe nonproliferative diabetic retinopathy that requires acute treatment Have had more than 1 episode of severe hypoglycemia, as defined by the American Diabetes Association criteria, within 6 months before screening or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms. Have a definitive diagnosis of autonomic neuropathy as evidenced by urinary retention, resting tachycardia, orthostatic hypotension, or diabetic diarrhea Have a history of acute or chronic pancreatitis Have a self or family history (first-degree relative) of multiple endocrine neoplasia type 2A or type 2B, thyroid C-cell hyperplasia, or medullary thyroid carcinoma Have calcitonin levels of 20 picograms per millilitre (pg/mL) or more at screening

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

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

Links:

URL

https://trials.lillytrialguide.com/en-US/trial/1xujziv0yfFVul40lqzrPv

Description

A Study of LY3493269 in Participants With Type 2 Diabetes

Learn more about this trial

A Study of LY3493269 in Participants With Type 2 Diabetes

We'll reach out to this number within 24 hrs