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A Study of Tirzepatide (LY3298176) in Healthy Participants

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT03375463
Collaborator
(none)
46
Enrollment
1
Location
5
Arms
12.3
Actual Duration (Months)
3.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study has three 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.

This study will last approximately 70 days for Part A or Part B and 92 days for Part C. This does not include screening. Screening is required within 28 days prior to the start of the study.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Masking Description:
Part A and Part B are not blinded. Part C is blinded to Participant and Investigator
Primary Purpose:
Basic Science
Official Title:
Pharmacokinetics, Safety, and Tolerability of a Solution Formulation of LY3298176 in Healthy Subjects
Actual Study Start Date :
Dec 19, 2017
Actual Primary Completion Date :
Dec 27, 2018
Actual Study Completion Date :
Dec 27, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Tirzepatide Test Part A

SC dose of tirzepatide solution formulation

Drug: Tirzepatide
Administered SC
Other Names:
  • LY3298176

    		•
    Experimental: Tirzepatide Reference Part A

    SC dose of tirzepatide lyophilized formulation

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176

    		•
    Experimental: Tirzepatide Formulation Part B

    IV dose of tirzepatide formulation

    Drug: Tirzepatide
    Administered IV
    Other Names:
  • LY3298176

    		•
    Experimental: Tirzepatide Part C

    Titrated SC doses of tirzepatide solution formulation

    Drug: Tirzepatide
    Administered SC
    Other Names:
  • LY3298176

    		•
    Placebo Comparator: Placebo Part C

    SC dose of placebo matching tirzepatide dose

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Pharmacokinetics (PK) Part A: Area Under the Concentration versus Time Curve (AUC) of Tirzepatide [Baseline up to 37 days]

      PK: AUC of tirzepatide

    2. Pharmacokinetics (PK) Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide [Baseline up to 37 days]

      PK: Cmax of tirzepatide

    3. Pharmacokinetics (PK) Part B: Area Under the Concentration versus Time Curve (AUC) of Tirzepatide [Baseline at least 70 days]

      PK: AUC of tirzepatide

    Secondary Outcome Measures

    1. Pharmacokinetics (PK) Part C: Area Under the Concentration versus Time Curve (AUC) of Tirzepatide [Baseline at least 92 days]

      PK: AUC of tirzepatide

    2. Pharmacokinetics (PK) Part C: Maximum Observed Drug Concentration (Cmax) of Tirzepatide [Baseline at least 92 days]

      PK: Cmax of tirzepatide

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Overtly healthy males or females, as determined by medical history and physical examination

    • Male participants: agree to use an effective method of contraception for the duration of the study and for 3 months following the last dose of investigational product

    • Female participants: not of childbearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. Women with an intact uterus are deemed postmenopausal if they are greater than or equal to (≥)45 years old and have not taken hormones or oral contraceptives within the last year and had cessation of menses for at least 1 year. Or, have had at least 6 months of amenorrhea with follicle-stimulating hormone levels consistent with a postmenopausal state

    • Have a body mass index of 18.5 to 32.0 kilograms per meter squared (kg/m²) inclusive

    Exclusion Criteria:

    • Currently enrolled in a clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study

    • Received treatment with a drug that has not received regulatory approval for any indication within 30 days of screening

    • Have a history of heart block, or a pulse rate (PR) interval greater than (>)200 milliseconds (msec), or any abnormality in the 12-lead electrocardiogram (ECG) at screening that, in the opinion of the investigator, increases the risks associated with participating in the study

    • Have a significant history of or current cardiovascular (myocardial infarction, congestive heart failure, cerebrovascular accident, venous thromboembolism, etc.), respiratory, hepatic, renal, gastrointestinal (GI), endocrine, hematological (including history of thrombocytopenia), or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs, or of constituting a risk when taking the study medication, or interfering with the interpretation of data

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Covance Dallas Texas United States 75247

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT03375463
    Other Study ID Numbers:
    • 16671
    • I8F-MC-GPGE
    First Posted:
    Dec 18, 2017
    Last Update Posted:
    Feb 4, 2019
    Last Verified:
    Jan 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Tirzepatide

    Study Results

    No Results Posted as of Feb 4, 2019