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A Study of LY3493269 in Participants With Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04515576
Recruitment Status : Completed
First Posted : August 17, 2020
Last Update Posted : March 11, 2022
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: LY3493269 Drug: Dulaglutide Drug: Placebo Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple-Ascending Subcutaneous Doses of LY3493269 in Patients With Type 2 Diabetes Mellitus
Actual Study Start Date : August 25, 2020
Actual Primary Completion Date : March 4, 2021
Actual Study Completion Date : March 4, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Dulaglutide

Arms and Interventions
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Arm Intervention/treatment
Experimental: LY3493269
LY3493269 administered Subcutaneous (SC).
 Drug: LY3493269
Administered SC
Active Comparator: Dulaglutide
Dulaglutide administered SC.
 Drug: Dulaglutide
Administered SC
Other Name: LY2189265
Placebo Comparator: Placebo
Placebo administered SC.
 Drug: Placebo
Administered SC


Outcome Measures
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Primary Outcome Measures :
  1. 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 [ Time Frame: Baseline through final follow-up at Day 57 ]
    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 :
  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3493269 [ Time Frame: Baseline through final follow-up at Day 57 ]
    PK: AUC of LY3493269

  2. PK: Maximum Concentration (Cmax) of LY3493269 [ Time Frame: Baseline through final follow-up at Day 57 ]
    PK: Cmax of LY3493269

  3. Pharmacodynamics (PD):Change from baseline to Day 29 in Fasting Glucose (FG) [ Time Frame: Baseline, Day 29 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515576


Locations
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United States, California
Anaheim Clinical Trials, LLC
Anaheim, California, United States, 92801
United States, Florida
Miami Research Associates
Miami, Florida, United States, 33143
United States, Texas
Clinical Trials of Texas, Inc.
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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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
More Information
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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04515576    
Other Study ID Numbers: 17530
J1X-MC-GZHC ( Other Identifier: Eli Lilly and Company )
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: March 11, 2022
Last Verified: February 15, 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Dulaglutide
Hypoglycemic Agents
Physiological Effects of Drugs