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

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: NCT04143802
Recruitment Status : Suspended (Enrollment on hold due to COVID-19 pandemic.)
First Posted : October 29, 2019
Last Update Posted : May 8, 2020
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 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 : December 18, 2019
Estimated Primary Completion Date : December 10, 2020
Estimated Study Completion Date : December 10, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dulaglutide

Arm Intervention/treatment
Experimental: LY3437943
LY3437943 administered subcutaneously (SC)
Drug: LY3437943
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




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 [ Time Frame: 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 [ Time Frame: Baseline through study completion (12 weeks) ]
    PK: AUC of LY3437943

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

  3. Change from Baseline in Mean Daily Plasma Glucose (PG) [ Time Frame: Baseline through Day 80 ]
    Change from baseline in mean daily PG from 6-point PG profile



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT04143802


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, Kansas
PRA Health Sciences
Lenexa, Kansas, United States, 66219
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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04143802    
Other Study ID Numbers: 17137
J1I-MC-GZBB ( Other Identifier: Eli Lilly and Company )
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
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