CompletedPhase 1Results posted

A Study of LY3502970 in Participants With Type 2 Diabetes

A Multiple-Dose Study in Participants With Type 2 Diabetes Mellitus to Investigate the Safety, Tolerability, Pharmacokinetics,and Pharmacodynamics of LY3502970

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Type 2 diabetes

Eligibility highlights

•BMI 18.5-45

Primary endpoint

•Serious AEs (any)

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 IDNCT04426474

Org study ID17681

Secondary ID2020-000125-86

Secondary IDJ2A-MC-GZGCEli Lilly and Company

Timeline

Milestones

Study first posted2020-06-11actual

Study start2020-10-08actual

Primary completion2021-07-12actual

Study completion2021-07-12actual

Last update posted2026-05-26actual

Results first posted2026-05-26actual

Assets

Investigational agents

Orforglipron

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age70 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Have type 2 diabetes mellitus (T2DM) for at least 6 months

•Have a glycated hemoglobin (HbA1c) value at screening of greater than or equal to (≥)7.0 percent (%) and less than or equal to (≤)10.5% and are treated with diet and exercise alone or a stable dose of metformin for at least 3 months prior to screening

•Have a body weight of ≥45 kilograms (kg) and have a body mass index of 18.5 to 45 kilograms per square meter (kg/m²), inclusive

•Have had a stable body weight for the 3 months prior to screening (less than [<]5% body weight change)

•Males and females (not considered woman of childbearing potential)

Exclusion criteria

•Have type 1 diabetes mellitus, latent autoimmune diabetes in adults or have had an episode of ketoacidosis or hyperosmolar state requiring hospitalization in the 6 months prior to screening

•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

•Show evidence of hepatitis B, and/or positive hepatitis B surface antigen

•Show evidence of human immunodeficiency virus (HIV) infection and/or positive human HIV antibodies

•Any glucose-lowering medications other than metformin within 3 months prior to screening

Endpoints (5)

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.

Coverage by outcome category

Safety / tolerability / PK

Glycemic / diabetes

2 endpoints

Secondary/protocol endpoint

Pharmacodynamics (PD): Change from Baseline to Week 12 in Fasting Plasma Glucose (FPG)

Time frame:Baseline, Week 12

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Posted result

Group	Least-squares mean · millimoles per litre (mmol/L)	95% CI
Placebo QD	-1.14	-
3/6/12/21 mg LY3502970 QD	-2.02	-
3/6/9 mg LY3502970 QD	-3.00	-
3/6/12/15 mg LY3502970 QD	-2.85	-
3/6/12/21/27 mg LY3502970 QD	-2.42	-
3/6/9/21/36/45 mg LY3502970 QD	-2.29	-

Least squares mean difference-0.8790% CI-2.15 - 0.40

Least squares mean difference-1.8690% CI-3.07 - -0.65

Least squares mean difference-1.7090% CI-2.91 - -0.50Least Squares Mean Difference

Least squares mean difference-1.2890% CI-2.52 - -0.03

Least squares mean difference-1.1490% CI-2.35 - 0.07

Secondary/protocol endpoint

PD: Change from Baseline to Week 12 in Fasting Insulin

Time frame:Baseline, Week 12

change from baseline, improvement

Posted result

Group	Mean · picomoles/litre (pmol/L)	95% CI
Placebo QD	-9.71	-
3/6/12/21 mg LY3502970 QD	-12.20	-
3/6/9 mg LY3502970 QD	-5.46	-
3/6/12/15 mg LY3502970 QD	15.16	-
3/6/12/21/27 mg LY3502970 QD	7.30	-
3/6/9/21/36/45 mg LY3502970 QD	-1.32	-

Difference in estimated mean change-2.5090% CI-30.82 - 25.83

Difference in estimated mean change4.2490% CI-25.81 - 34.30

[difference in estimated mean change24.8790% CI-9.91 - 59.65

[difference in estimated mean change17.0190% CI-16.55 - 50.57

[difference in estimated mean change8.3890% CI-23.19 - 39.95

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

Time frame:Baseline through Follow-up (up to Day 105)

Serious AEs (any)

event count, event

Posted result

Group	Participants	95% CI
Placebo QD	1	-
3/6/12/21 mg LY3502970 QD	0	-
3/6/9 mg LY3502970 QD	0	-
3/6/12/15 mg LY3502970 QD	0	-
3/6/12/21/27 mg LY3502970 QD	0	-
3/6/9/21/36/45 mg LY3502970 QD	0	-

Secondary/protocol endpoint

Pharmacokinetics (PK): Maximum Observed Concentration (Cmax) of LY3502970

Time frame:Day 1 through Day 84: Predose up to 96 hours postdose

Cmax

concentration, descriptive

Posted result

Group	Geometric mean · nanograms/milliliter (ng/mL)	95% CI
3/6/12/21 mg LY3502970 QD	101	-
3/6/9 mg LY3502970 QD	57.9	-
3/6/12/15 mg LY3502970 QD	97.9	-
3/6/12/21/27 mg LY3502970 QD	191	-
3/6/9/21/36/45 mg LY3502970 QD	218	-

Secondary/protocol endpoint

PK: Area Under the Concentration Versus Time Curve of LY3502970

Time frame:Day 1 through Day 84: Predose up to 96 hours postdose

AUC₀-∞

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 2026

Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)

Results tableClinicalTrials.gov results section

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 July 6, 2026 snapshot.