CompletedPhase 1

A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment.

A Phase 1, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Renal Function and Participants With Renal Impairment

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Renal impairment, Type 2 diabetes

Eligibility highlights

•BMI 18.5-42•eGFR ≥90•Healthy volunteers

Primary endpoints

•AUC•PK: Area under the concentration versus time curve from time zero to last time•PK: Maximum observed concentration (Cmax) of LY3502970

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 IDNCT05936138

Org study ID18633

Secondary IDJ2A-MC-GZPCEli Lilly and Company

Timeline

Milestones

Study first posted2023-07-07actual

Study start2023-07-13actual

Primary completion2024-04-11actual

Study completion2024-04-11actual

Last update posted2024-04-23actual

Assets

Investigational agents

Orforglipron

Who this study enrolls

Healthy volunteersRenal impairmentType 2 diabetes

Who can enroll

Minimum age18 Years

Maximum age85 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Have a body mass index within the range 18.5 to 42.0 kilograms per meter squared (kg/m²), inclusive.

•Men and women who agree to use highly effective or effective methods of contraception may participate in this trial.

Participants with Normal Renal Function:

•Healthy males or females as determined by medical history, physical examination, and other screening procedures, with normal renal function. Have estimated glomerular filtration rate (eGFR) of greater than or equal to 90 milliliter per minute (mL/min)

Participants with Renal Impairment:

•Severe renal impairment: Have eGFR of 15 to 29 mL/min and not requiring hemodialysis.

•ESRD: Participants who have been on a stable hemodialysis schedule for at least 3 months prior to planned dosing.

Exclusion criteria

•Have a current, functioning organ transplant. Non-functional renal allografts may be allowed.

•Regularly use known drugs of abuse or show positive findings on urinary drug screen that are not otherwise explained by permitted concomitant medications.

•Have known allergies to LY3502970, related compounds, or any components of the formulation, or history of severe atopy.

•Are lactating, pregnant, or intend to become pregnant, or to breastfeed during the study.

•Have a history or presence of chronic or acute pancreatitis

Participants with Renal Impairment:

•Have hemoglobin <8.5 g/dL.

•Participants with Type 2 Diabetes Mellitus if they have taken any Glucagon-like Peptide-1 Receptor Agonists (GLP1-RA) or a Dipeptidyl Peptidase 4 (DPP4) inhibitor in the past 6 weeks or 5 half-lives prior to dosing, whichever is longer, prior to dosing on Day 1

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

Pharmacokinetics (PK): Area under the concentration versus time curve from time zero to infinity (AUC0-∞) of LY3502970

Time frame:Predose up to 12 days postdose

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

PK: Area under the concentration versus time curve from time zero to last time point (AUC0-tlast) of LY3502970

Time frame:Predose up to 12 days postdose

concentration, descriptive

Primary/protocol endpoint

PK: Maximum observed concentration (Cmax) of LY3502970

Time frame:Predose up to 12 days postdose

Cmax

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 6, 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 6, 2026 snapshot.