A Study of Tirzepatide (LY3298176) in Healthy Participants

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetics, Safety, and Tolerability of a Solution Formulation of LY3298176 in Healthy Subjects

Conditions
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Healthy

Intervention / Treatment
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* Drug: Tirzepatide
* Drug: Tirzepatide
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tirzepatide Test Part A<br>SC dose of tirzepatide solution formulation | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Experimental: Tirzepatide Reference Part A<br>SC dose of tirzepatide lyophilized formulation | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Experimental: Tirzepatide Formulation Part B<br>IV dose of tirzepatide formulation | Drug: Tirzepatide<br>* Administered IV<br>* Other names: LY3298176;|
| Experimental: Tirzepatide Part C<br>Titrated SC doses of tirzepatide solution formulation | Drug: Tirzepatide<br>* Administered SC<br>* Other names: LY3298176;|
| Placebo Comparator: Placebo Part C<br>SC dose of placebo matching tirzepatide dose | Drug: Placebo<br>* Administered SC<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) Part A: Area Under the Concentration versus Time Curve (AUC) of Tirzepatide | PK: AUC of tirzepatide | Baseline up to 37 days | 
| Pharmacokinetics (PK) Part A: Maximum Observed Drug Concentration (Cmax) of Tirzepatide | PK: Cmax of tirzepatide | Baseline up to 37 days | 
| Pharmacokinetics (PK) Part B: Area Under the Concentration versus Time Curve (AUC) of Tirzepatide | PK: AUC of tirzepatide | Baseline at least 70 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (PK) Part C: Area Under the Concentration versus Time Curve (AUC) of Tirzepatide | PK: AUC of tirzepatide | Baseline at least 92 days | 
| Pharmacokinetics (PK) Part C: Maximum Observed Drug Concentration (Cmax) of Tirzepatide | PK: Cmax of tirzepatide | Baseline at least 92 days |