A Study of Tirzepatide (LY3298176) In Participants After A Lifestyle Weight Loss Program
Part of paid clinical trials in Huntington Park, California.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT04657016
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tirzepatide — DRUGAdministered SC
- Placebo — OTHERAdministered SC
Study Details
This is a study of tirzepatide in participants with obesity. The purpose of this study is to learn more about how tirzepatide maintains body weight or adds to weight loss after an intensive lifestyle modification program. The study will last about 2 years (29 visits).
Key Dates
- Start date
- Mar 29, 2021
- Status verified
- May 2024
- Primary completion
- Apr 20, 2023
- Completion
- May 12, 2023
Study Design
- Enrollment
- 579 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: TirzepatideParticipants received weekly doses of tirzepatide subcutaneously (SC) for 72 weeks, starting at 2.5 milligrams (mg) for 4 weeks. Subsequently, the dose was increased by 2.5 mg every 4 weeks up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.
- Placebo Comparator: PlaceboParticipants received matching placebo SC once weekly (QW).
Primary Outcome Measure
Percent Change From Baseline in Body Weight [ Time Frame: Baseline, 72 Weeks ]
Locations (45)
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National Research Institute - Huntington Park· Huntington Park, CANational Research Institute - Wilshire· Los Angeles, CACatalina Research Institute, LLC· Montclair, CANational Research Institute (NRI) - Santa Ana· Santa Ana, CAEncompass Clinical Research· Spring Valley, CADiablo Clinical Research, Inc.· Walnut Creek, CA
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