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CompletedPhase 1

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

Asset

LY3537021

Subcutaneous · GIP agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

85

Study population

Healthy volunteers, Type 2 diabetes

Eligibility highlights

•BMI 18.5-40•Healthy volunteers

Primary endpoint

•One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04586907
Org study ID17730
Secondary IDJ2R-MC-YAABEli Lilly and Company

Timeline

Milestones

Study first posted2020-10-14actual
Study start2020-11-23actual
Primary completion2021-11-30actual
Study completion2021-11-30actual
Last update posted2021-12-17actual

Assets

Investigational agents

LY3537021

Who this study enrolls

Healthy volunteersType 2 diabetes

Who can enroll

Minimum age21 Years
Maximum age70 Years
SexAll
Healthy volunteersAccepted

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

Endpoints (3)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

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)

event count, event

Secondary/protocol endpoint

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)

concentration, descriptive

Secondary/protocol endpoint

PK: Maximum Concentration (Cmax) of LY3537021

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

concentration, descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateNovember 5, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the November 5, 2026 snapshot.