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Completed

NCT Number: NCT04680767

A Study of LY3502970 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).

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Key information

Conditions

Healthy

Age range

35 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research

Leeds, LS2 9LH, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

[¹⁴C]-LY3502970

Drug

Administered orally.

Primary outcomes

  1. 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

    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.

  2. 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

    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.

Secondary outcomes

  1. 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

    PK: AUC0-tlast of plasma LY3502970

  2. 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

    PK: AUC0-tlast of total radioactivity in plasma and whole blood

  3. 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

    PK: AUC(0-∞) of plasma LY3502970

  4. 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

    PK: AUC(0-∞) of total radioactivity in plasma and whole blood

  5. 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

    PK: Cmax of plasma LY3502970

  6. 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

    PK: Cmax of total radioactivity in plasma and whole blood

  7. 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

    • 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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Dec 23, 2020
Registry last updated
May 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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