CompletedPhase 1Results posted

A Study of LY3502970 in Participants With Impaired and Normal Liver Function

A Phase 1, Multicenter, Parallel, Single-Dose, Open-Label, Single-Period Study of LY3502970 in Participants With Normal Hepatic Function and Participants With Mild, Moderate, or Severe Hepatic Impairment

Lead sponsor

Eli Lilly and Company

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

Recruiting sites

Actual enrollment

Study population

Healthy volunteers, Hepatic impairment

Eligibility highlights

•BMI 18.5-40•HbA1c ≥5%•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 IDNCT05882032

Org study ID18624

Secondary IDJ2A-MC-GZPBEli Lilly and Company

Timeline

Milestones

Study first posted2023-05-31actual

Study start2023-06-13actual

Primary completion2024-11-18actual

Study completion2024-11-18actual

Last update posted2026-05-27actual

Results first posted2026-05-27actual

Assets

Investigational agents

Orforglipron

Who this study enrolls

Healthy volunteersHepatic impairment

Who can enroll

Minimum age18 Years

Maximum age80 Years

SexAll

Healthy volunteersAccepted

Inclusion criteria

•Men or women with body weight of at least 45 kilograms and a body mass index of 18.5 to 40.0 kilograms per meter squared (kg/m²).

•Both healthy individuals and individuals with hepatic impairment classified as Child-Pugh Score A, B, C that is mild, moderate, or severe impairment, respectively, liver disease can participate who are considered acceptable for participation in this study by the investigator.

•Participants must have a diagnosis of chronic hepatic impairment for more than 6 months per physician diagnosis and standard of care practice, with no clinically significant changes within 15 days prior to study intervention administration.

•Participants may have mild stable baseline medical conditions for which neither the condition nor treatments received would negatively impact the health of the participant or study conduct.

•Have acceptable BP and pulse rate, as determined by the investigator at screening.

•No significant history of spontaneous or ethanol induced hypoglycemia.

•Participants with Mild to Severe Hepatic Impairment who have a hemoglobin level of at least 8.5 grams/deciliter.

•Participants with both T2DM and Hepatic Impairment have T2DM controlled with diet or exercise alone or on stable doses of anti-diabetic medications metformin or sulfonylureas, for at least 8 weeks prior to screening.

•Participants with both T2DM and Hepatic Impairment have a hemoglobin A1c greater than or equal to 5.0% and less than or equal to 11.0% at the screening visit.

•Participants with both T2DM and Hepatic Impairment have clinical laboratory test results within normal range or deemed clinically insignificant by the investigator. Abnormalities of serum glucose, serum lipids, urinary glucose, and urinary protein consistent with T2DM are acceptable.

Exclusion criteria

•Have significant history of, or current, cardiovascular, respiratory, hepatic (applies to Group 1 only), renal, GI, endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs.

•Have a history or presence of pancreatitis, elevation in serum amylase or lipase (greater than 1.5-fold ULN) or GI disorder or any GI disease, which impacts gastric emptying.

•Have any abnormality in the 12-lead ECG at screening.

•Have severe atopy or have a history of clinically significant multiple or severe drug allergies or severe post treatment hypersensitivity reactions.

•Have a history of, or current psychiatric disorders.

•Women who are pregnant, intend to become pregnant or are breastfeeding a child are not eligible to participate.

•Have taken any glucose-lowering medications other than metformin, sulfonylureas, and insulin, in the past 6 weeks or 5 half-lives (whichever is longer) prior to planned dosing.

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.

Safety / tolerability / PK

6 endpoints

Primary/registry result

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC [0-∞]) of LY3502970

Time frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1

concentration, descriptive

Posted result

Group	Geometric mean · nanogram hour per milliliter (ngh/mL)	95% CI
1 mg LY3502970 (Control: Normal Hepatic Function)	130	-
1 mg LY3502970 (Mild Hepatic Impairment)	132	-
1 mg LY3502970 (Moderate Hepatic Impairment)	209	-
1 mg LY3502970 (Severe Hepatic Impairment)	611	-

Primary/registry result

PK: Area Under the Concentration Versus Time Curve From Time Zero to Last Time Point (AUC0-tlast) of LY3502970

Time frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1

concentration, descriptive

Posted result

Group	Geometric mean · ng*h/mL	95% CI
1 mg LY3502970 (Control: Normal Hepatic Function)	109	-
1 mg LY3502970 (Mild Hepatic Impairment)	112	-
1 mg LY3502970 (Moderate Hepatic Impairment)	169	-
1 mg LY3502970 (Severe Hepatic Impairment)	385	-

Primary/registry result

PK: Maximum Observed Concentration (Cmax) of LY3502970

Time frame:Pre-dose, 0.5, 1, 2, 4, 6, 8, 12, 16, 24, 36, 48, 72, and 96 hours post-dose on Day 1

concentration, descriptive

Posted result

Group	Geometric mean · nanograms per milliliter (ng/mL)	95% CI
1 mg LY3502970 (Control: Normal Hepatic Function)	5.10	-
1 mg LY3502970 (Mild Hepatic Impairment)	5.47	-
1 mg LY3502970 (Moderate Hepatic Impairment)	6.12	-
1 mg LY3502970 (Severe Hepatic Impairment)	5.95	-

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 96 hours 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 96 hours postdose

AUC₀-∞

concentration, descriptive

Primary/protocol endpoint

PK: Maximum observed concentration (Cmax) of LY3502970

Time frame:Predose up to 96 hours 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 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.