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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT04050670 (opens ClinicalTrials.gov in a new tab)Other id17224Other idI8F-MC-GPHI
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Overview

Status
Completed
Phase
Phase 1
Enrollment
54 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
13 Sept 2019
Primary completion
3 Apr 2020
Completion
3 Apr 2020
First posted
8 Aug 2019
Last update posted
6 May 2023
Conditions
Healthy

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201920202021
  1. Ph 1

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

    NCT04050670

    13 Sept 2019 to 3 Apr 2020

Registry summary

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

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.

Interventions

  • TirzepatideDrug

Arms3

  • 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.

Primary outcomes2

Outcomes the sponsor listed as primary.

  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

    Registry description

    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

    Registry description

    PK: Maximum Concentration (Cmax) of Tirzepatide was evaluated.

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 outcomeGeometric mean· 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-∞])

GroupValue (Hour * nanogram per milliliter (h*ng/mL))Spread
Tirzepatide - Abdomen11200024
Tirzepatide - Upper Arm11100021
Tirzepatide - Thigh10600022
Primary outcomeGeometric mean· Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose

PK: Maximum Concentration (Cmax) of Tirzepatide

GroupValue (Nanogram per Millilitre (ng/mL))Spread
Tirzepatide - Abdomen60325
Tirzepatide - Upper Arm55623
Tirzepatide - Thigh52021

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Tirzepatide - AbdomenParticipants received 5mg Tirzepatide by subcutaneous injection on abdomen.0 / 540 / 5437 / 54
Tirzepatide - Upper ArmParticipants received 5mg Tirzepatide by subcutaneous injection on upper arm.0 / 540 / 5431 / 54
Tirzepatide - ThighParticipants received 5mg Tirzepatide by subcutaneous injection on thigh.0 / 530 / 5323 / 53

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
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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