A Research Study Looking at Similarity Between Tirzepatide Versions for Different Injection Devices

Part of paid clinical trials in South Miami, Florida.

Sponsor
Eli Lilly and Company
Study ID
NCT05810597
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Single Dose Pen — DEVICE
    Used to administer tirzepatide SC
  • Multi-use Prefilled Pen — DEVICE
    Used to administer tirzepatide SC

Study Details

The main purpose of this study is to look at the amount of the study drug, tirzepatide, that gets into the blood stream and how long it takes the body to get rid of it when given using two different devices. The study will also evaluate the safety and tolerability of tirzepatide and information about any side effects experienced will be collected. For each participant, the total duration of the study will be approximately 14 weeks, including screening.

Key Dates

Start date
Apr 3, 2023
Status verified
Jul 2024
Primary completion
Jul 17, 2023
Completion
Jul 17, 2023

Study Design

Enrollment
65 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Sequence 1: Tirzepatide by Single Dose Pen (SDP)/ Multi-use Prefilled Pen (MUPFP)
    Participants received a single dose of 5 milligrams (mg) tirzepatide administered subcutaneously (SC) via an SDP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 2. There was a washout period of at least 35 days between tirzepatide dose administrations.
  • Experimental: Sequence 2: Tirzepatide by MUPFP / SDP
    Participants received a single dose of 5 mg tirzepatide administered SC via a MUPFP in Period 1 followed by a single dose of 5 mg tirzepatide administered SC via an SDP in Period 2. There was a washout period of at least 35 days between tirzepatide dose administrations.

Primary Outcome Measure

Pharmacokinetics (PK): Maximum Concentration (Cmax) of Tirzepatide [ Time Frame: Predose, 8, 12, 24, 36, 48, 72, 96, 120, 144, 168, 336, and 480 hours post Day 1 dose and on Day 36 of each study period. ]

Locations (3)

FacilityCityStateZIPSite coordinators
Qps-Mra, LlcSouth MiamiFlorida33143-
ICON Early Phase ServicesSan AntonioTexas78209-
ICONSalt Lake CityUtah84124-

Find similar trials in South Miami, FL

By research site
Qps-Mra, Llc· South Miami, FLICON Early Phase Services· San Antonio, TXICON· Salt Lake City, UT

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