A Study of Tirzepatide Administered by Two Different Devices in Healthy Participants

NCT04004988 | Completed Phase 1 Results FDA Drug

• 2 other identifiers: 17105I8F-MC-GPGS
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when given as a solution formulation via an autoinjector versus a conventional prefilled syringe. The tolerability of tirzepatide will also be evaluated and information about any adverse effects experienced will be collected. Screening is required within 28 days prior to the start of the study. For each participant, the total duration of the clinical trial will be about 14 weeks, including screening.

Conditions

Healthy

Outcome Measures

Primary Outcomes (2)

• Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide From Time Zero to Infinity (AUC0toinf)

  Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve (AUC) of Tirzepatide from Time Zero to Infinity (AUC0toinf) was reported.

  Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose

• PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide

  PK: Maximum Observed Plasma Concentration (Cmax) of Tirzepatide was reported

  Predose, 8hours(h), 12h, 24h, 36h, 48h, 72h, 96h, 120h, 144h, 168h, 336h , 480h, 864h postdose

Study Arms (2)

Tirzepatide Test

EXPERIMENTAL

Participants received single dose of 5 milligram (mg) Tirzepatide by subcutaneous injection (SC) via an autoinjector (AI) in one of two study periods.

Drug: Tirzepatide; Device: Auto-injector (AI)

Tirzepatide Reference

EXPERIMENTAL

Participants received single dose of 5mg Tirzepatide by subcutaneous injection (SC) via a prefilled syringe (PFS) in one of two study periods.

Drug: Tirzepatide; Device: Prefilled syringe (PFS)

Interventions

Tirzepatide DRUG

Administered SC

Also known as: LY3298176

Tirzepatide Reference; Tirzepatide Test

Prefilled syringe (PFS) DEVICE

PFS used to administer tirzepatide

Tirzepatide Reference

Auto-injector (AI) DEVICE

AI used to administer tirzepatide

Tirzepatide Test

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
• Are between the body mass index (BMI) of 18.0 and 32.0 kilograms per meter squared (kg/m²), inclusive, at screening
• Are agreeable to receiving study treatment by injections under the skin

You may not qualify if:

• Have known allergies to tirzepatide or related compounds
• Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
• Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or GI disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
• Have a prior history of malignant disease(s) in the past 5 years prior to screening
• Smoke more than the equivalent of 10 cigarettes per day
• Is a known user of drugs of abuse

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

Lilly Nus Centre for Clin Pharmacology

Singapore, 138623, Singapore

Location

MeSH Terms

Interventions

Tirzepatide

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide-1 Receptor; Glucagon-Like Peptide Receptors; Receptors, G-Protein-Coupled; Receptors, Cell Surface; Membrane Proteins; Proteins; Amino Acids, Peptides, and Proteins; Receptors, Gastrointestinal Hormone; Receptors, Peptide

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2019
• First Posted: July 2, 2019
• Study Start: August 19, 2019
• Primary Completion: December 16, 2019
• Study Completion: December 16, 2019
• Last Updated: April 18, 2023
• Results First Posted: April 18, 2023

Record last verified: 2023-04-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)