Phase 1
N=6
A Study of LY3502970 in Healthy Male Participants
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT04680767 ↗Enrolled (actual)
6
Serious AEs
0.0%
Results posted
May 2026
Primary outcome: Primary: Feces Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered — 86.75 percentage of the total radioactive dose
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 1
- Interventions
- [¹⁴C]-LY3502970 (Drug)
- Age
- Adult · 35+ yrs
- Sex
- Male
- Sponsor
- Eli Lilly and Company
- Primary completion
- Jul 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feces Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
86.75 | — |
| PRIMARY Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered |
0.24 | — |
| SECONDARY 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 |
210 | — |
| SECONDARY 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 |
266; 103 | — |
| SECONDARY PK: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC (0-∞)] of Plasma LY3502970 |
223 | — |
| SECONDARY PK: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC (0-∞)] of Total Radioactivity in Plasma and Whole Blood |
292; 135 | — |
| SECONDARY PK: Maximum Concentration (Cmax) of Plasma LY3502970 |
10.4 | — |
| SECONDARY PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood |
10.7; 5.92 | — |
| SECONDARY Total Number of Metabolites of LY3502970 in Plasma, Urine and Feces |
2; NA; 12 | — |
Summary
The main purpose of this study is to measure how much of the study drug gets into the bloodstream and how long it takes the body to eliminate it. This study will involve a single dose of ¹⁴C radiolabelled LY3502970. This means that a radioactive substance will be incorporated into the study drug. The purposes are to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine and feces. The study will last up to 8 weeks (maximum).
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT04680767). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.