HealthyPhase 1NCT04680767
A Study of LY3502970 in Healthy Male Participants
A Phase 1 study testing [¹⁴C]-LY3502970 in people with Healthy, run by Eli Lilly and Company at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- [¹⁴C]-LY3502970
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 29 Mar 2021to 3 Jul 2021
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Disposition of [¹⁴C]-LY3502970 Following Oral Administration in Healthy Male Participants
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).
- Conditions
- Healthy
- Being tested
- [¹⁴C]-LY3502970
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[¹⁴C]-LY3502970Drug
Administered orally.
| Study group | Role | What they receive |
|---|---|---|
| 3mg [¹⁴C]-LY3502970 | Experimental | Participants received a single oral dose of 3 milligrams (mg) of carbon-14-labeled [¹⁴C]-LY3502970, containing approximately 200 microcuries (µCi) of radioactivity on Day 1. Receives: Drug: [¹⁴C]-LY3502970 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feces Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Feces excretion of LY3502970 radioactivity over time expressed as a percentage of the total radioactive dose administered. Feces samples collected from 0 hour (h), where 0h = time of dose administration, through 384h postdose were used to assess this outcome.
Measured: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, and 384 hours (h) postdose
Urinary Excretion of LY3502970 Radioactivity Over Time Expressed as a Percentage of the Total Radioactive Dose Administered
Urinary excretion of LY3502970 radioactivity over time expressed as a percentage of the total radioactive dose administered. Urine samples collected from 0 hour (h), where 0h = time of dose administration, through 384h postdose were used to assess this outcome.
Measured: 0, 24, 48, 72, 96, 120, 144, 168, 192, 216, 240, 264, 288, 312, 336, 360, and 384 hours (h) postdose
Secondary outcomes (7)
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
PK: AUC0-tlast of plasma LY3502970
Measured: 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
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
PK: AUC0-tlast of total radioactivity in plasma and whole blood
Measured: 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
PK: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC (0-∞)] of Plasma LY3502970
PK: AUC(0-∞) of plasma LY3502970
Measured: 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
PK: Area Under the Concentration-Time Curve From Time Zero to Infinity [AUC (0-∞)] of Total Radioactivity in Plasma and Whole Blood
PK: AUC(0-∞) of total radioactivity in plasma and whole blood
Measured: 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
PK: Maximum Concentration (Cmax) of Plasma LY3502970
PK: Cmax of plasma LY3502970
Measured: 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
PK: Maximum Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood
PK: Cmax of total radioactivity in plasma and whole blood
Measured: 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
Total Number of Metabolites of LY3502970 in Plasma, Urine and Feces
- Total number of metabolites of LY3502970 in plasma, urine and feces samples pooled across participants to assess the presence of metabolites.
- Urine and feces samples collected as a 12-hour predose interval (-12 to 0 hour [h], where 0h = time of dose administration) and then continuously postdose in specified intervals through 384h were used to assess this outcome.
- Feces Sample collection time frame : -12 to 0, 0-24, 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2020
- Study start29 Mar 2021
- Primary completion3 Jul 2021
- Study completion3 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680767
- Sponsor's protocol ID
- 17784
- Other IDs
- J2A-MC-GZGF
- Status last verified
- Apr 2026
- First submitted
- 21 Dec 2020
- Last updated
- 26 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No