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 — DRUG
    Administered SC
  • Placebo — OTHER
    Administered 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: Tirzepatide
    Participants 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: Placebo
    Participants received matching placebo SC once weekly (QW).

Primary Outcome Measure

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

Locations (45)

FacilityCityStateZIPSite coordinators
National Research Institute - Huntington ParkHuntington ParkCalifornia90255-
National Research Institute - WilshireLos AngelesCalifornia90057-
Catalina Research Institute, LLCMontclairCalifornia91763-
National Research Institute (NRI) - Santa AnaSanta AnaCalifornia92704-
Encompass Clinical ResearchSpring ValleyCalifornia91978-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Chase Medical Research, LLCWaterburyConnecticut06708-
Clinical Research of South FloridaCoral GablesFlorida33134-
New Horizon Research CenterMiamiFlorida33165-
Precision Clinical ResearchSunriseFlorida33351-
Clinical Research of West FloridaTampaFlorida33606-
Metabolic Research Institute, Inc.West Palm BeachFlorida33401-
Elite Clinical TrialsBlackfootIdaho83221-
Solaris Clinical ResearchMeridianIdaho83646-
Elite Clinical TrialsRexburgIdaho83440-
Evanston Premier Healthcare Research LLCEvanstonIllinois60201-
American Health Network of IN, LLCAvonIndiana46123-
American Health Network of IN, LLCFranklinIndiana46131-
American Health Network of IN, LLCMuncieIndiana47304-
Cotton O'Neil MulvaneTopekaKansas66606-
Tandem Clinical Research,LLCMarreroLouisiana70072-
The National Diabetes & Obesity Research InstituteBiloxiMississippi39532-
Clinvest Research LLCSpringfieldMissouri65810-
Quality Clinical ResearchOmahaNebraska68114-
Palm Research Center SunsetLas VegasNevada89148-
Rochester Clinical Research, Inc.RochesterNew York14609-
University of North Carolina Medical CenterChapel HillNorth Carolina27514-
PharmQuestGreensboroNorth Carolina27408-
Wake Forest University Baptist Medical Center (WFUBMC)Winston-SalemNorth Carolina27157-
Cleveland Clinic FoundationClevelandOhio44122-
Intend Research, LLCNormanOklahoma73069-
Summit Research NetworkPortlandOregon97210-
Detweiler Family Medicine & AssociatesLansdalePennsylvania19446-
Penn Medicine: University of Pennsylvania Health SystemPhiladelphiaPennsylvania19104-
Preferred Primary Care Physicians, Preferred Clinical Research-St. ClairPittsburghPennsylvania15243-
Tribe Clinical Research, LLCGreenvilleSouth Carolina29607-
Holston Medical GroupBristolTennessee37620-
Vanderbilt Health One Hundred OaksNashvilleTennessee37204-
Dallas Diabetes Research CenterDallasTexas75230-
Juno ResearchHoustonTexas77040-
Southern Endocrinology AssociatesMesquiteTexas75149-
Texas Diabetes & Endocrinology, P.A.Round RockTexas78681-
Consano Clinical Research, LLCShavano ParkTexas78231-
Health Research of Hampton Roads, Inc.Newport NewsVirginia23606-
MultiCare Institute for Research & InnovationTacomaWashington98405-

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