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CompletedPhase 1Results posted

A Study of LY3502970 in Healthy Male Participants

Disposition of [¹⁴C]-LY3502970 Following Oral Administration in Healthy Male Participants

Asset

Orforglipron

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

6

actual

Study population

Healthy volunteers

Key I/E criteria

BMI 18-32MaleHealthy volunteers

Primary endpoints

Feces Excretion of LY3502970 Radioactivity Over Time Expressed as a PercentageUrinary Excretion of LY3502970 Radioactivity Over Time Expressed asFecal Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage

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 IDNCT04680767
Org study ID17784
Secondary IDJ2A-MC-GZGFEli Lilly and Company

Timeline

Milestones

Study first posted2020-12-23actual
Study start2021-03-29actual
Primary completion2021-07-03actual
Study completion2021-07-03actual
Last update posted2026-05-26actual
Results first posted2026-05-26actual

Assets

Investigational agents

Study populations

Who this study enrolls

Healthy volunteers

Eligibility

Who can enroll

Minimum age35 Years
Maximum age55 Years
SexMale
Healthy volunteersAccepted

Inclusion criteria

Are overtly healthy males
Body weight within 50 and 100 kilograms (kg), inclusive, and body mass index within the range 18.0 and 32.0 kilograms per square meter (kg/m²) (inclusive)

Exclusion criteria

Females
Have significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; of constituting a risk when taking the investigational product (IP); or of interfering with the interpretation of data
Have a history of Gilbert's syndrome or have total bilirubin level (TBL) above upper limit of normal (ULN) at screening
Have evidence of significant active neuropsychiatric disease, as determined by the investigator
Have had any exposure to LY3502970 or any other glucagon-like peptide-1 (GLP-1) analogs, or other related compounds within the prior 3 months, or any history of allergies to these medications
Are currently enrolled in a clinical study involving an investigational product (IP) or any other type of medical research judged not to be scientifically or medically compatible with this study
Have participated, within the last 3 months, in a clinical study involving an IP. If the previous IP has a long half-life, 5 half-lives or 3 months (whichever is longer) should have passed, prior to check-in
Have participated in any clinical trial involving a radiolabeled IP within 12 months prior to check-in
Show evidence of human immunodeficiency virus (HIV) infection and/or positive HIV antibodies
Show evidence of hepatitis C and/or positive hepatitis C antibody
Show evidence of hepatitis B and/or positive hepatitis B surface antigen
Have had exposure to significant diagnostic, therapeutic, or employment-related radiation within 12 months prior to dosing (e.g., serial x-ray or computed tomography scans, barium meal, current employment in a job requiring radiation exposure monitoring)

Endpoints (16)

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

16 endpoints
Primary/registry result

Feces Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Time frame:0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, and 384 hours (h) postdose

descriptive

Posted result

GroupValue (mean), percentage of the total radioactive dose95% CI
3mg [¹⁴C]-LY350297086.75
Primary/registry result

Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Time frame:0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, and 384 hours (h) postdose

descriptive

Posted result

GroupValue (mean), percentage of the total radioactive dose95% CI
3mg [¹⁴C]-LY35029700.24
Primary/protocol endpoint

Fecal Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Time frame:Predose up to Day 17 after administration of study drug

percent change from baseline, descriptive

Primary/protocol endpoint

Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered

Time frame:Predose up to Day 17 after administration of study drug

descriptive

Secondary/registry result

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve t, Where t is the Last Time Point With a Measurable Concentration (AUC0- Tlast) of Plasma LY3502970

Time frame:Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram*hour per milliliter(ng*h/mL)95% CI
3mg [¹⁴C]-LY3502970210
Secondary/registry result

PK: Area Under the Concentration Versus Time Curve t, Where t is the Last Time Point With a Measurable Concentration ((AUC0- Tlast) of Total Radioactivity in Plasma and Whole Blood

Time frame:Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram equivalents*hour per milliliter95% CI
3mg [¹⁴C]-LY3502970AUC0-tlast of Plasma Total Radioactivity266
AUC0-tlast of Whole Blood Total Radioactivity103
Secondary/registry result

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

Time frame:Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram*hour per milliliter(ng*h/mL)95% CI
3mg [¹⁴C]-LY3502970223
Secondary/registry result

PK: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC (0-∞)] of Total Radioactivity in Plasma and Whole Blood

Time frame:Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram equivalents*hour per milliliter95% CI
3mg [¹⁴C]-LY3502970AUC(0-∞) of Plasma Total Radioactivity292
AUC(0-∞) of Whole Blood Total Radioactivity135
Secondary/registry result

PK: Maximum Concentration (Cmax) of Plasma LY3502970

Time frame:Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram per milliliter(ng/mL)95% CI
3mg [¹⁴C]-LY350297010.4
Secondary/registry result

PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood

Time frame:Predose, 0.5, 1, 2, 4, 8, 12, 16, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, 384 hours (h) postdose

concentration, descriptive

Posted result

GroupValue (geometric_mean), nanogram equivalents per milliliter95% CI
3mg [¹⁴C]-LY3502970Cmax of Plasma Total Radioactivity10.7
Cmax of Whole Blood Total Radioactivity5.92
Secondary/registry result

Total Number of Metabolites of LY3502970 in Plasma, Urine and Feces

Time frame:Plasma: 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120 h postdose; Urine: -12 to 0, 0-6, 6-12, 12-24, 24-48, 48-72, 72-96, 96-120, 120-144, 144-168, 168-192, 192-216, 216-240, 240-264, 264-288, 288-312, 312-336, 336-360, 360-384h postdose

concentration, descriptive

Posted result

GroupValue (number), number of metabolites95% CI
3mg [¹⁴C]-LY3502970Plasma2
UrineNA
Feces12
Secondary/protocol endpoint

Plasma Pharmacokinetics (PK): Area under the Concentration-Time Curve (AUC) of LY3502970

Time frame:Predose up to Day 17 after administration of study drug

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Plasma PK: Maximum Concentration (Cmax) of LY3502970

Time frame:Predose up to Day 17 after administration of study drug

Cmax

concentration, descriptive

Secondary/protocol endpoint

Plasma and Whole Blood PK of Radioactivity: AUC

Time frame:Predose up to Day 17 after administration of study drug

AUC₀–∞

concentration, descriptive

Secondary/protocol endpoint

Plasma and Whole Blood PK of Radioactivity: Cmax

Time frame:Predose up to Day 17 after administration of study drug

Cmax

concentration, descriptive

Secondary/protocol endpoint

Relative Abundance of LY3502970 and it's Metabolites in Plasma, Feces, and Urine

Time frame:Predose up to Day 17 after administration of study drug

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.