Study of Tirzepatide in Healthy Participants

NCT04311424 | Completed Phase 1 Results

• 3 other identifiers: 17378I8F-MC-GPHX2019-003664-44
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to look at how much tirzepatide gets into the bloodstream and how long the body takes to get rid of it. This study will involve a single dose of 14C radiolabelled tirzepatide. This means that a radioactive tracer substance, C14, will be incorporated into the study drug to investigate the study drug and its breakdown products and to find out how much of these pass from blood into urine, feces and expired air. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be approximately 15 weeks, including screening.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

  Urinary Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered.

  Pre-dose and up to 63 days post-dose

• Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered

  Fecal Excretion of Tirzepatide Radioactivity Over Time Expressed As A Percentage of the Total Radioactive Dose Administered.

  Pre-dose and up to 63 days post-dose

Secondary Outcomes (6)

• Total Number of Metabolites

  Pre-dose and up to 63 days post-dose

• Total Radioactivity Recovered in Urine, Feces, and Expired Air (if Applicable)

  Pre-dose and up to 63 days post-dose

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Tirzepatide

  Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

• PK: Maximum Concentration (Cmax) of Tirzepatide

  Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) From Zero To Infinity (AUC[0-∞]) of Total Radioactivity

  Pre-dose, Day 1, 2, 3, 4, 5, 6, 7, 10, 12, 14, 22, 29, 36, 43, 50, 57, and 64 post dose

Study Arms (1)

14C Tirzepatide

EXPERIMENTAL

A single dose of \[14C\]-tirzepatide administered subcutaneously (SC).

Drug: 14C Tirzepatide

Interventions

14C Tirzepatide DRUG

Administered SC.

Also known as: LY3298176

14C Tirzepatide

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Overtly healthy males as determined by medical history, physical examination, and other screening procedures
• Have a body mass index (BMI) between 18.0 to 32.0 kilograms per meter squared (kg/m²), inclusive at screening
• Are willing to be available for the full duration of the study

You may not qualify if:

• Have known allergies to tirzepatide or related compounds
• Have a medical condition or medical history that makes participation in the study unsafe or which may interfere in the interpretation of the results of the study
• Have had exposure to significant radiation within 12 months prior to dosing (for example, multiple x-ray or computed tomography \[CT\] scans, barium meal, being employed in a job requiring radiation exposure monitoring)
• Have participated in any clinical trial involving a radiolabeled substance within the past 12 months

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Covance Clinical Research Ltd

Leeds, West Yorkshire, LS2 9LH, United Kingdom

Location

MeSH Terms

Interventions

Tirzepatide

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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)

  Eli Lilly and Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2020
• First Posted: March 17, 2020
• Study Start: July 28, 2020
• Primary Completion: October 2, 2020
• Study Completion: October 2, 2020
• Last Updated: March 24, 2023
• Results First Posted: March 24, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)