A Study of LY3537021 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
NCT ID: NCT04586907
Last Updated: 2021-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE1
85 participants
INTERVENTIONAL
2020-11-23
2021-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
This study will last up to about 19 weeks including screening period.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
LY3537021 (Part A/Healthy)
LY3537021 administered subcutaneously (SC) to healthy participants.
LY3537021
Administered SC.
LY3537021 (Part A/Type 2 Diabetes)
LY3537021 administered SC to participants with type 2 diabetes mellitus (T2DM).
LY3537021
Administered SC.
Placebo (Part A)
Placebo administered SC.
Placebo
Administered SC.
LY3537021 (Part B/Healthy)
LY3537021 administered SC to healthy participants.
LY3537021
Administered SC.
LY3537021 (Part B/Type 2 Diabetes)
LY3537021 administered SC to participants with T2DM.
LY3537021
Administered SC.
Placebo (Part B)
Placebo administered SC.
Placebo
Administered SC.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
LY3537021
Administered SC.
Placebo
Administered SC.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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
21 Years
70 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Eli Lilly and Company
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
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)
Role: STUDY_DIRECTOR
Eli Lilly and Company
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Lilly Centre for Clinical Pharmacology
Singapore, , Singapore
Countries
Review the countries where the study has at least one active or historical site.
Related Links
Access external resources that provide additional context or updates about the study.
A Study of LY3537021 in Healthy Participants and Participants With Type 2 Diabetes Mellitus
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
J2R-MC-YAAB
Identifier Type: OTHER
Identifier Source: secondary_id
17730
Identifier Type: -
Identifier Source: org_study_id