A Study of Tirzepatide (LY3298176) in Healthy Participants

Part of paid clinical trials in Dallas, Texas.

Sponsor
Eli Lilly and Company
Study ID
NCT03375463
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

Study Details

This study has four parts. Each participant will enroll in one part. Part A: The purpose of Part A is to compare study drug tirzepatide solution formulation to a powder formulation mixed with water and given subcutaneously (SC) (just under the skin). Part A will measure how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Part B: The purpose of Part B is to evaluate the safety and tolerability of tirzepatide intravenous (IV) formulation when administered into a vein. Part C: The purpose of Part C is to evaluate the safety and tolerability of tirzepatide following multiple SC weekly doses of a solution. Part D: The purpose of Part D is to evaluate the safety and tolerability of tirzepatide following single IV bolus dose of lyophilized formulation. This study will last approximately 70 days for each part (Part A, Part B or Part D) and 92 days for Part C. This does not include screening. Screening is required within 28 days prior to the start of the study.

Key Dates

Start date
Dec 19, 2017
Status verified
Feb 2024
Primary completion
Dec 27, 2018
Completion
Dec 27, 2018

Study Design

Enrollment
52 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: 5 mg Tirzepatide SC (Solution)-Part A
    Participants received 5 milligrams (mg) of tirzepatide subcutaneous (SC) solution formulation.
  • Experimental: 5 mg Tirzepatide SC (Lyophilized)-Part A
    Participants received 5 mg of tirzepatide SC lyophilized formulation.
  • Experimental: 0.5 mg LY3298176 IV-Part B
    Participants received Intravenous (IV) infusion of a single 0.5 mg dose of tirzepatide formulation.
  • Experimental: 5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C
    Participants received tirzepatide subcutaneous solution at 5 mg on Days 1 (week 1) and 8 (Week 2), 7.5 mg on Day 15 (Week 3) and 10 mg on Day 22 (Week 4).
  • Placebo Comparator: Placebo SC-Part C
    Participants received SC injection of placebo.
  • Experimental: 0.5 mg LY3298176 Bolus IV-Part D
    Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation.

Primary Outcome Measure

Pharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide [ Time Frame: Part A: Predose, 8, 12, 24, 48, 72, 96, 120, 144, 168, 336, 480, 816-864 hours postdose ]

Locations (1)

FacilityCityStateZIPSite coordinators
CovanceDallasTexas75247-

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By research site
Covance· Dallas, TX

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