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Completed

NCT Number: NCT04143802

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

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.

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Key information

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Anaheim Clinical Trials, LLC, Anaheim, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LY3437943

Drug

Administered SC

Dulaglutide

Drug

Administered SC

Other names: LY2189265

Placebo

Drug

Administered SC

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Oct 29, 2019
Registry last updated
Jan 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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