Phase 1 N=52 Randomized Double-blind Basic Science

A Study of Tirzepatide (LY3298176) in Healthy Participants

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT03375463 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2024

Primary outcome: Primary: Pharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide — 113000; 109000 nanograms*hours per milliliter(ng*hr/mL)

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: Tirzepatide (Drug); Placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Eli Lilly and Company
Primary completion: Dec 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetics (PK) Part A: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide	113000; 109000	—
PRIMARY PK Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide	524; 575	—
PRIMARY PK Part B: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide	6680	—
SECONDARY PK Part C: Area Under the Concentration Versus Time Curve [AUC (0-τ)] of Tirzepatide	68900; 149000	—
SECONDARY PK Part C: Maximum Observed Drug Concentration (Cmax) of Tirzepatide	663; 1270; 1900	—
SECONDARY PK Part D: Area Under the Concentration Versus Time Curve [AUC (0-∞)] of Tirzepatide	14000	—

Summary

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03375463). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.