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GLP-1 Receptor Agonist

Tirzepatide - Test for Healthy Subjects

Phase 1
Waitlist Available
Research Sponsored by Eli Lilly and Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Body mass index (BMI) between 18.5 and 30.0 kilograms per meter squared (kg/m²), inclusive, at screening
Are agreeable to receiving study treatment by injections under the skin
Timeline
Screening 3 weeks
Treatment Varies
Follow Up predose up to 36 days postdose
Awards & highlights

Study Summary

This trial evaluates the effectiveness, safety and tolerability of tirzepatide. Participants will be monitored over 14 weeks, and side effects recorded.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
Your BMI must be between 18.5 and 30 kg/m² at the time of screening.
Select...
You have consented to receiving subcutaneous injections as part of the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~predose up to 36 days postdose
This trial's timeline: 3 weeks for screening, Varies for treatment, and predose up to 36 days postdose for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
PK: Area Under the Plasma Concentration Versus Time Curve From Zero to Infinity (AUC[0-∞]) of Tirzepatide
PK: Area Under the Plasma Concentration Versus Time Curve from Zero to Time t (AUC[0-t]) of Tirzepatide
Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Tirzepatide - TestExperimental Treatment2 Interventions
A single dose of tirzepatide administered by subcutaneous (SC) injection via a test device (test formulation)
Group II: Tirzepatide - ReferenceActive Control2 Interventions
A single dose of tirzepatide administered by SC injection via a reference device (reference formulation)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tirzepatide
2019
Completed Phase 3
~7590
Test
2021
Completed Phase 3
~1540

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Eli Lilly and CompanyLead Sponsor
2,605 Previous Clinical Trials
3,199,605 Total Patients Enrolled
Study DirectorEli Lilly and Company
1,338 Previous Clinical Trials
403,780 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Tirzepatide - Test?

"Limited clinical data exists surrounding the safety and efficacy profiles of Tirzepatide, so it recieved a score of 1."

Answered by AI

Do individuals of a certain age qualify for this clinical experiment?

"This trial has distinct guidelines that only allow participants aged between 18 and 70 to take part. There are 54 studies for minors, while 372 are available for seniors."

Answered by AI

What are the eligibility requirements for participation in this clinical research project?

"To partake in this medical experiment, subjects must be fit and between 18 to 70 years old. At the moment, 65 people are being enrolled for the trial."

Answered by AI

Are there any available slots for participants in this research endeavor?

"According to clinicaltrials.gov, this research project is no longer recruiting members for participation; the trial was first posted on April 3rd 2023 and its most recent update was made on March 31st 2023. Although it is not actively seeking candidates now, there are 817 ongoing trials currently looking for participants."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What site did they apply to?
ICON Early Phase Services
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I have tried multiple ways to lose weight, but have been unsuccessful.
PatientReceived 2+ prior treatments
~34 spots leftby Mar 2025