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Trial · Interventional

CompletedPhase 1Results postedRegistry data

A Study of LY3502970 in Healthy Male Participants

NCTNCT04680767 (opens ClinicalTrials.gov in a new tab)Other id17784Other idJ2A-MC-GZGF
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 1
Enrollment
6 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

United Kingdom

Start
29 Mar 2021
Primary completion
3 Jul 2021
Completion
3 Jul 2021
First posted
23 Dec 2020
Last update posted
26 May 2026
Conditions
Healthy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20212022
  1. Ph 1

    A Study of LY3502970 in Healthy Male Participants

    NCT04680767

    29 Mar 2021 to 3 Jul 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • [¹⁴C]-LY3502970Drug

Arms1

  • Experimental

    3mg [¹⁴C]-LY3502970

    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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  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

    Registry description

    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

    Registry description

    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(7)

  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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    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

    Registry description

    * 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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· 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

GroupValue (percentage of the total radioactive dose)Spread
3mg [¹⁴C]-LY350297086.752.78
Primary outcomeMean· 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

GroupValue (percentage of the total radioactive dose)Spread
3mg [¹⁴C]-LY35029700.240.02
Secondary and other outcome results(6)
Secondary outcomeGeometric mean· 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

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

GroupValue (nanogram*hour per milliliter(ng*h/mL))Spread
3mg [¹⁴C]-LY350297021014
Secondary outcomeGeometric mean· 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

GroupValue (nanogram equivalents*hour per milliliter)Spread
3mg [¹⁴C]-LY350297026621
Secondary outcomeGeometric mean· 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

GroupValue (nanogram*hour per milliliter(ng*h/mL))Spread
3mg [¹⁴C]-LY350297022313
Secondary outcomeGeometric mean· 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

GroupValue (nanogram equivalents*hour per milliliter)Spread
3mg [¹⁴C]-LY350297029221
Secondary outcomeGeometric mean· 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

GroupValue (nanogram per milliliter(ng/mL))Spread
3mg [¹⁴C]-LY350297010.414
Secondary outcomeGeometric mean· 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

GroupValue (nanogram equivalents per milliliter)Spread
3mg [¹⁴C]-LY350297010.717

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
3mg [¹⁴C]-LY3502970Participants received a single oral dose of 3mg of carbon-14-labeled \[¹⁴C\]-LY3502970, containing approximately 200 µCi of radioactivity on Day 1.0 / 60 / 66 / 6

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
Male
Age
from 35 Years up to 55 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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)

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