DelfaGLP-1 Atlas

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CompletedPhase 1

A Study of LY3502970 in Japanese Participants With Type 2 Diabetes Mellitus

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

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

5

Recruiting sites

—

Enrollment

62

actual

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c 7-10%

Primary endpoint

•Treatment-emergent AEs (any) (Treatment-emergent AEs (any), 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 IDNCT05086445
Org study ID17610
Secondary IDJ2A-JE-GZGBEli Lilly and Company

Timeline

Milestones

Study first posted2021-10-21actual
Study start2021-11-12actual
Primary completion2022-09-05actual
Study completion2022-09-05actual
Last update posted2022-11-28actual

Assets

Investigational agents

Orforglipron

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
Maximum age70 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•Males and females not of childbearing potential
•Have type 2 diabetes mellitus (T2DM) diagnosed for at least 1 year
•Have glycated hemoglobin (HbA1c) value ≥ 7.0% and ≤ 10.0% for participants treated with diet and exercise or HbA1c ≥ 6.5% and ≤ 9.0% for participants who have washed out antidiabetic medications at screening
•Have type 2 diabetes controlled with diet and exercise alone or are stable on a single oral antidiabetic medication (OAM); either metformin, DPP-4 (dipeptidyl peptidase-4) inhibitor, or SGLT2 (sodium-glucose co-transporter-2) inhibitor within 3 months prior to screening. Participants must withdraw from their OAM treatment for at least 28 days prior to dosing.

Exclusion criteria

•Have type 1 diabetes mellitus or latent autoimmune diabetes in adults.
•Have uncontrolled diabetes defined as an episode of ketoacidosis or hyperosmolar state requiring hospitalization
•Have had an episode of severe hypoglycemia, as defined by the occurrence of neuroglycopenic symptoms requiring the assistance of another person for recovery or have a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
•Have a history of acute or chronic pancreatitis or fasting serum triglyceride level of >500 milligram per deciliter (mg/dL).
•Have known liver disease, obvious clinical signs or symptoms of liver disease, acute or chronic hepatitis, or have elevations in aminotransferases (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) greater than 3× upper limit of normal (ULN).

Endpoints (6)

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
Weight & body composition
1

Weight & body composition

1 endpoint
Secondary/protocol endpoint

Change from Baseline in Body Weight

Time frame:Baseline through Day 88

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

2 endpoints
Secondary/protocol endpoint

Change from Baseline in Fasting Glucose

Time frame:Baseline through Day 85

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Change from Baseline in Glycated Hemoglobin (HbA1c)

Time frame:Baseline through Day 85

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Safety / tolerability / PK

3 endpoints
Primary/protocol endpoint

Number of Participants with One or More Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Time frame:Baseline through Week 15

Treatment-emergent AEs (any)

event count, event

componentsTreatment-emergent AEs (any), Serious AEs (any)

Secondary/protocol endpoint

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

Time frame:Predose on Day 1 through up to Day 88

Cmax

concentration, descriptive

Secondary/protocol endpoint

PK: Area Under the Concentration Versus Time Curve (AUC) of LY3502970

Time frame:Predose on Day 1 through up to Day 88

AUC₀–∞

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 dateJuly 1, 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 July 1, 2026 snapshot.