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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

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

4

Recruiting sites

Enrollment

24

actual

Study population

Healthy volunteers, Renal impairment, Type 2 diabetes

Key I/E criteria

BMI 18.5-42eGFR ≥90Healthy volunteers

Primary endpoints

AUCPK: Area under the concentration versus time curve from time zero to last timePK: Maximum observed concentration (Cmax) of LY3502970

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 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

Study populations

Who this study enrolls

Healthy volunteersRenal impairmentType 2 diabetes

Eligibility

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 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.