A Study of Tirzepatide (LY3298176) in Japanese Participants With Type 2 Diabetes

Sponsor
Eli Lilly and Company
Study ID
NCT03322631
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Administered SC.
  • Placebo — DRUG
    Administered SC.

Study Details

The 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 remove it. * How tirzepatide affects the levels of blood sugar. This study includes eight weekly doses of tirzepatide or placebo given as subcutaneous (SC) injections just under the skin. The study will last about 16 weeks (total), including screening and follow-up. This study is for research purposes only and is not intended to treat any medical conditions.

Key Dates

Start date
Nov 15, 2017
Status verified
Jun 2022
Primary completion
May 29, 2018
Completion
Nov 28, 2018

Study Design

Enrollment
48 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Tirzepatide
    Participants received escalating doses of 2.5 milligrams (mg), 5 mg, 10 mg and 15 mg of tirzepatide administered into the subcutaneous (SC) tissue of the abdominal wall.
  • Placebo Comparator: Placebo
    Participants received placebo administered into the SC tissue of the abdominal wall.

Primary Outcome Measure

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration [ Time Frame: Baseline through Day 85 ]

Related Studies