A Study of Tirzepatide (LY3298176) in Healthy Participants

Lilly

Status and phase

Completed

Phase 1

Conditions

Healthy

Treatments

Drug: Placebo

Drug: Tirzepatide

Study type

Interventional

Funder types

Industry

Identifiers

NCT03375463

16671

I8F-MC-GPGE (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

52 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

52 participants in 6 patient groups, including a placebo group

5 mg Tirzepatide SC (Solution)-Part A

Experimental group

Description:

Participants received 5 milligrams (mg) of tirzepatide subcutaneous (SC) solution formulation.

Treatment:

Drug: Tirzepatide

5 mg Tirzepatide SC (Lyophilized)-Part A

Experimental group

Description:

Participants received 5 mg of tirzepatide SC lyophilized formulation.

Treatment:

Drug: Tirzepatide

0.5 mg LY3298176 IV-Part B

Experimental group

Description:

Participants received Intravenous (IV) infusion of a single 0.5 mg dose of tirzepatide formulation.

Treatment:

Drug: Tirzepatide

5 mg/7.5 mg/ 10 mg Tirzepatide SC-Part C

Experimental group

Description:

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).

Treatment:

Drug: Tirzepatide

Placebo SC-Part C

Placebo Comparator group

Description:

Participants received SC injection of placebo.

Treatment:

Drug: Placebo

0.5 mg LY3298176 Bolus IV-Part D

Experimental group

Description:

Participants received IV bolus of 0.5 mg tirzepatide lyophilized formulation.