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A Study of Tirzepatide (LY3298176) in Healthy Participants and Participants With Type 2 Diabetes (T2DM)

NCT02759107 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2024-01-16

Study results available
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Summary

The main purposes of this study are to determine:

* The safety of tirzepatide and any side effects that might be associated with it.
* How much tirzepatide gets into the bloodstream and how long it takes the body to get rid of it.
* How tirzepatide affects the levels of blood sugar.

This study includes 3 parts (A, B and C). Part A involves a single dose of tirzepatide taken as a subcutaneous (SC) injection just under the skin and will be approximately 10 weeks in duration, including screening. Parts B and C involve 4 doses of tirzepatide taken once weekly (over 4 weeks) as a SC injection just under the skin and is approximately 12-14 weeks in duration, including screening. Each participant will enroll in only one part.

This study is for research purposes only, and is not intended to treat any medical condition.

Conditions

  • Healthy
  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

Tirzepatide

Administered SC

DRUG

Placebo

Administered SC

DRUG

Dulaglutide

Administered SC

Sponsors & Collaborators

Principal Investigators

  • 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 Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-05-11
Primary Completion
2017-06-26
Completion
2017-06-26

Countries

  • United States
  • Singapore

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02759107 on ClinicalTrials.gov