A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes

Overview

The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of tirzepatide will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 20 weeks, including screening.

Full Title of Study: “Effect of Injection Site on the Relative Bioavailability of a Single Dose of Tirzepatide in Subjects With Low and High Body Mass Indices”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 3, 2020

Interventions

  • Drug: Tirzepatide
    • Tirzepatide administered SC

Arms, Groups and Cohorts

  • Experimental: Tirzepatide – Upper Arm
    • Participants received 5mg Tirzepatide by subcutaneous injection on upper arm.
  • Experimental: Tirzepatide – Thigh
    • Participants received 5mg Tirzepatide by subcutaneous injection on thigh.
  • Active Comparator: Tirzepatide – Abdomen
    • Participants received 5mg Tirzepatide by subcutaneous injection on abdomen.

Clinical Trial Outcome Measures

Primary Measures

  • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞])
    • Time Frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose
    • Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞]) was evaluated.
  • PK: Maximum Concentration (Cmax) of Tirzepatide
    • Time Frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose
    • PK: Maximum Concentration (Cmax) of Tirzepatide was evaluated.

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures – Are between the body mass index (BMI) of 18.5 and 45.0 kilograms per meter squared (kg/m²), inclusive, at screening – Are agreeable to receiving study treatment by injections under the skin Exclusion Criteria:

  • Have known allergies to tirzepatide or related compounds – Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2 – Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors – Have a prior history of malignant disease(s) in the past 5 years prior to screening – Smoke more than the equivalent of 10 cigarettes per day – Is a known user of drugs of abuse

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Eli Lilly and Company
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • 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

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