A Study of Tirzepatide (LY3298176) in Participants With Obesity Disease

Sponsor
Eli Lilly and Company
Study ID
NCT04844918
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tirzepatide — DRUG
    Administered SC
  • Placebo — OTHER
    Administered SC

Study Details

The main purpose of this study is to learn more about tirzepatide in participants with obesity disease. The study will also measure how Tirzepatide affects body weight with a low-calorie diet and increased physical activity. The study will last around 72 Weeks.

Key Dates

Start date
May 10, 2021
Status verified
Jun 2024
Primary completion
Jun 24, 2023
Completion
Jun 24, 2023

Study Design

Enrollment
267 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: 10 Milligrams (mg) Tirzepatide
    Participants received maintenance dose 10 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg and then 10 mg tirzepatide administered subcutaneously (SC) once weekly (QW).
  • Experimental: 15 mg Tirzepatide
    Participants received maintenance dose 15 mg with dose escalation starting from 2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg and then 15 mg tirzepatide administered SC QW.
  • Placebo Comparator: Placebo
    Participants received matching placebo administered SC QW.

Primary Outcome Measure

Mean Percent Change in Body Weight [ Time Frame: Baseline, 72 Weeks ]

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