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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy; Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Placebo; Drug: LY3537021

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Phase 1

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 138623
    • Lilly Centre for Clinical Pharmacology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LY3537021 (Part A/Healthy); LY3537021 administered subcutaneously (SC) to healthy participants.	Drug: LY3537021; Administered SC.
EXPERIMENTAL: LY3537021 (Part A/Type 2 Diabetes); LY3537021 administered SC to participants with type 2 diabetes mellitus (T2DM).	Drug: LY3537021; Administered SC.
PLACEBO_COMPARATOR: Placebo (Part A); Placebo administered SC.	Drug: Placebo; Administered SC.
EXPERIMENTAL: LY3537021 (Part B/Healthy); LY3537021 administered SC to healthy participants.	Drug: LY3537021; Administered SC.
EXPERIMENTAL: LY3537021 (Part B/Type 2 Diabetes); LY3537021 administered SC to participants with T2DM.	Drug: LY3537021; Administered SC.
PLACEBO_COMPARATOR: Placebo (Part B); Placebo administered SC.	Drug: Placebo; Administered SC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration	A summary of SAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module	Baseline through Day 119 (Part A) and Day 57 (Part B)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of LY3537021	PK: AUC of LY3537021	Predose Day 1 through Day 119 (Part A) and Day 57 (Part B)
PK: Maximum Concentration (Cmax) of LY3537021	PK: Cmax of LY3537021	Predose Day 1 through Day 119 (Part A) and Day 57 (Part B)

Collaborators and Investigators

• Sponsor: Eli Lilly and Company

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 23, 2020
• Primary Completion (ACTUAL): November 30, 2021
• Study Completion (ACTUAL): November 30, 2021

Study Registration Dates

• First Submitted: October 12, 2020
• First Submitted That Met QC Criteria: October 12, 2020
• First Posted (ACTUAL): October 14, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 17730; J2R-MC-YAAB (OTHER: Eli Lilly and Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No