DelfaGLP-1 Atlas

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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

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

6

Recruiting sites

—

Enrollment

68

actual

Study population

Type 2 diabetes

Key I/E criterion

•BMI 18.5-45

Primary endpoint

•Serious AEs (any)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. 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

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

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
3
Glycemic / diabetes
2

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

GroupValue (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

GroupValue (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 QD15.16—
3/6/12/21/27 mg LY3502970 QD7.30—
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

GroupValue (count_of_participants), Participants95% CI
Placebo QD1—
3/6/12/21 mg LY3502970 QD0—
3/6/9 mg LY3502970 QD0—
3/6/12/15 mg LY3502970 QD0—
3/6/12/21/27 mg LY3502970 QD0—
3/6/9/21/36/45 mg LY3502970 QD0—
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

GroupValue (geometric_mean), nanograms/milliliter (ng/mL)95% CI
3/6/12/21 mg LY3502970 QD101—
3/6/9 mg LY3502970 QD57.9—
3/6/12/15 mg LY3502970 QD97.9—
3/6/12/21/27 mg LY3502970 QD191—
3/6/9/21/36/45 mg LY3502970 QD218—
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 1, 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 1, 2026 snapshot.