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Completed

NCT Number: NCT04586907

A Study of LY3537021 in Healthy Participants and Participants With Type 2 Diabetes Mellitus

The main purpose of this study is to learn more about the safety of LY3537021 and any side effects that might be associated with it in healthy participants and participants with type 2 diabetes mellitus (T2DM). Blood tests will be performed to check how much LY3537021 gets into the bloodstream and how long the body takes to eliminate it.

This study will last up to about 19 weeks including screening period.

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Key information

Age range

21 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Lilly Centre for Clinical Pharmacology

Singapore, 138623

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Are overtly healthy males or females not of childbearing potential, as determined through medical history and physical examination
  • Contraceptive use by men should also be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
  • Have a body mass index of 18.5 to 40 kilograms per square meter (kg/m²), inclusive
  • Have hemoglobin A1c level of less than or equal to (≤)6.5 percent (%)

Patients with Type 2 Diabetes Mellitus (T2DM):

  • Have T2DM for at least 6 months
  • For Part A, have a hemoglobin A1c value at screening of 6.5% to 11% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening. For Part B, have hemoglobin A1c value at screening of 6.5% to 10% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening with or without 1 other OAM, such as DPP-IV inhibitors, SGLT-2 inhibitors, or sulfonylureas

Exclusion criteria

  • Have an abnormality in the 12-lead electrocardiogram (ECG) that, in the opinion of the investigator, increases the risks associated with participating in the study or may confound ECG data analysis
  • Have a history of malignancy within 5 years prior to screening
  • Have obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis
  • Have evidence of significant active psychiatric disorder(s) as determined by the investigator
  • Have undergone any form of bariatric surgery
  • Have donated blood of 450 milliliters (mL) or more in the past 3 months or any blood donation within the past month from screening
  • Have an average weekly alcohol intake that exceeds 21 units per week (males up to age 65 years) and 14 units per week (females and males above 65 years), or are unwilling to stop alcohol consumption 24 hours prior to dosing until discharge from the investigative site
  • Smoke >10 cigarettes per day or the equivalent or are unable or unwilling to refrain from nicotine during investigative site admission

Patients with T2DM:

  • Have had any of the following within the past 6 months prior to screening: myocardial infarction, unstable angina, coronary artery bypass graft, percutaneous coronary intervention (diagnostic angiograms are permitted), transient ischemic attack, cerebrovascular accident or decompensated congestive heart failure, or currently have New York Health Association Class III or IV heart failure
  • Are currently treated with or within the past 3 months had treatment with GLP-1 receptor agonists, or insulin
  • Have had severe hypoglycemic event in the last 3 months

Treatment and study plan

LY3537021

Drug

Administered SC.

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 119 (Part A) and Day 57 (Part B)

    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 (AUC) of LY3537021

    Time frame: Predose Day 1 through Day 119 (Part A) and Day 57 (Part B)

    PK: AUC of LY3537021

  2. PK: Maximum Concentration (Cmax) of LY3537021

    Time frame: Predose Day 1 through Day 119 (Part A) and Day 57 (Part B)

    PK: Cmax of LY3537021

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of LY3537021 in Healthy Participants and Patients With Type 2 Diabetes Mellitus

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 14, 2020
Registry last updated
Dec 17, 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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