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NCT04050670

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

Completed Phase 1 Results posted Last updated 6 May 2023
What this trial tests

Phase 1 trial testing Tirzepatide in Healthy in 54 participants. Completed in 3 April 2020.

Timeline
13 September 2019
Primary endpoint
3 April 2020
3 April 2020

Quick facts

Lead sponsorEli Lilly and Company
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposebasic science
Enrollment54
Start date13 September 2019
Primary completion3 April 2020
Estimated completion3 April 2020
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Eli Lilly and Company — full company profile →

Who can join

Adults 18 to 70, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve of Tirzepatide From Time Zero to Infinity (AUC[0-∞]) Primary · 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.

GroupValue95% CI
Tirzepatide - Abdomen112000± 24
Tirzepatide - Upper Arm111000± 21
Tirzepatide - Thigh106000± 22
PK: Maximum Concentration (Cmax) of Tirzepatide Primary · Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, 480 hours post dose

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

GroupValue95% CI
Tirzepatide - Abdomen603± 25
Tirzepatide - Upper Arm556± 23
Tirzepatide - Thigh520± 21

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 36 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Tirzepatide - Abdomen
Serious: 0/54 (0%)
Deaths: 0/54
Tirzepatide - Upper Arm
Serious: 0/54 (0%)
Deaths: 0/54
Tirzepatide - Thigh
Serious: 0/53 (0%)
Deaths: 0/53
Other adverse events (11 terms — click to expand)

ReactionSystemTirzepatide - AbdomenTirzepatide - Upper ArmTirzepatide - Thigh
NauseaGastrointestinal disorders
Decreased appetiteMetabolism and nutrition disorders
HeadacheNervous system disorders
DyspepsiaGastrointestinal disorders
Abdominal distensionGastrointestinal disorders
VomitingGastrointestinal disorders
ConstipationGastrointestinal disorders
EructationGastrointestinal disorders
DiarrhoeaGastrointestinal disorders
FlatulenceGastrointestinal disorders
Early satietyGeneral disorders

Data from ClinicalTrials.gov NCT04050670 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other trials of Tirzepatide

Trials testing the same drug.

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Eli Lilly and Company trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04050670.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing