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 — DRUGAdministered SC
- Placebo — OTHERAdministered 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) TirzepatideParticipants 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 TirzepatideParticipants 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: PlaceboParticipants received matching placebo administered SC QW.
Primary Outcome Measure
Mean Percent Change in Body Weight [ Time Frame: Baseline, 72 Weeks ]
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