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Completed

NCT Number: NCT04050670

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

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.

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Covance Clinical Research Inc

Daytona Beach, Florida, 32117, United States

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Tirzepatide

Drug

Tirzepatide administered SC

Other names: LY3298176

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study title

Effect of Injection Site on the Relative Bioavailability of a Single Dose of Tirzepatide in Subjects With Low and High Body Mass Indices

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 8, 2019
Registry last updated
May 6, 2023

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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