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Completed

NCT Number: NCT04515576

A Study of LY3493269 in Participants With Type 2 Diabetes

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.

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Key information

Age range

18 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

  • 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

Treatment and study plan

LY3493269

Drug

Administered SC

Dulaglutide

Drug

Administered SC

Other names: LY2189265

Placebo

Drug

Administered SC

Primary outcomes

  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

    TEAE is an untoward medical occurrence that emerges during a defined treatment period, having been absent pretreatment, or worsens relative to the pretreatment state, and does not necessarily have to have a causal relationship with this treatment.

    An SAE is defined as any untoward medical occurrence that, at any dose:

    • Results in death
    • Is life-threatening
    • Requires inpatient hospitalization or prolongation of existing hospitalization
    • Results in persistent disability/incapacity
    • Is a congenital anomaly/birth defect
    • Other situations: Based on medical or scientific judgement.

    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 outcomes

  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269

    Time frame: Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.

    Area Under the Concentration Versus Time Curve from Time Zero to 168 Hours Postdose AUC(0-168) of LY3493269

  2. PK: Maximum Observed Drug Concentration (Cmax) of LY3493269

    Time frame: Predose, 6, 12, 24, 48, 72, 96 and 168 h postdose at Weeks 1 and 4.

    Maximum Observed Drug Concentration (Cmax) of LY3493269

  3. Pharmacodynamics (PD):Change From Baseline to Day 29 in Fasting Plasma Glucose

    Time frame: Baseline, Day 29

    Pharmacodynamics (PD): Summary Statistics (Mean, Standard Deviation) of Change From Baseline to Day 29.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 17, 2020
Registry last updated
Jan 14, 2025

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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