A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight for the Maintenance of Weight Loss

Part of paid clinical trials in Pelham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT04660643
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 was a study of tirzepatide in participants with obesity or overweight. The main purpose was to learn more about how tirzepatide maintained body weight loss. The study had two phases: a lead-in phase in which all participants took tirzepatide and a treatment phase in which participants either continued tirzepatide or switched to placebo. The study lasted about 2 years (25 visits).

Key Dates

Start date
Mar 29, 2021
Status verified
May 2024
Primary completion
Apr 25, 2023
Completion
May 18, 2023

Study Design

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

Arms

  • Experimental: Tirzepatide (lead-in)
    Participants received weekly doses of tirzepatide subcutaneously (SC) for 36 weeks, starting at 2.5 milligrams (mg) and increasing by 2.5 mg every 4 weeks, as tolerated, up to the maximum tolerated dose (MTD) of either 10 mg or 15 mg.
  • Experimental: Tirzepatide MTD
    Participants continued tirzepatide MTD (either 10 mg or 15 mg) for an additional 52 weeks.
  • Placebo Comparator: Placebo
    Participants received weekly doses of placebo SC for 52 weeks.

Primary Outcome Measure

Percent Change From Randomization in Body Weight at Week 88 [ Time Frame: Randomization (Week 36), Week 88 ]

Locations (48)

FacilityCityStateZIPSite coordinators
Cahaba ResearchPelhamAlabama35124-
Scripps Memorial Hospital La JollaLa JollaCalifornia92037-
National Research Institute - WilshireLos AngelesCalifornia90057-
National Research InstitutePanorama CityCalifornia91402-
Artemis Institute for Clinical ResearchSan DiegoCalifornia92103-
University Clinical Investigators, Inc.TustinCalifornia92780-
New West Physicians Clinical ResearchGoldenColorado80401-
Optumcare Colorado Springs - MonumentMonumentColorado80132-
Care Partners Clinical ResearchJacksonvilleFlorida32277-
South Florida Clinical Research InstituteMargateFlorida33063-
Renstar Medical ResearchOcalaFlorida34470-
ForCare Clinical ResearchTampaFlorida33613-
Endocrine Research Solutions, Inc.RoswellGeorgia30076-
SKY Clinical Research Network Group-BlakeUnion CityGeorgia30291-
East-West Medical Research InstituteHonoluluHawaii96814-
Rocky Mountain Clinical ResearchIdaho FallsIdaho83404-
Healthcare Research Network - ChicagoFlossmoorIllinois60422-
Clinical Investigation SpecialistsGurneeIllinois60031-
Midwest Institute For Clinical ResearchIndianapolisIndiana46260-
American Health Network of Indiana, LLC - New AlbanyNew AlbanyIndiana47150-
Cotton O'Neil ClinicTopekaKansas66606-
L-MARC Research CenterLouisvilleKentucky40213-
Centennial Medical GroupElkridgeMaryland21075-
MedStar Health Research Institute (MedStar Physician Based Research Network)HyattsvilleMaryland20782-
ActivMed Practices and ResearchMethuenMassachusetts01844-
Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroyMichigan48098-
StudyMetrix ResearchCity of Saint PetersMissouri63303-
Glacier View Research Institute - EndocrinologyKalispellMontana59901-
Weill Cornell Medical CollegeNew YorkNew York10065-
University of North Carolina Medical CenterChapel HillNorth Carolina27514-
PharmQuestGreensboroNorth Carolina27408-
Wake Forest University Baptist Medical Center (WFUBMC)Winston-SalemNorth Carolina27157-
Lillestol ResearchFargoNorth Dakota58104-
Aventiv Research IncColumbusOhio43213-
Intend Research, LLCNormanOklahoma73069-
Summit Research NetworkPortlandOregon97210-
Capital Area Research, LLCCamp HillPennsylvania17011-
Tribe Clinical Research, LLCGreenvilleSouth Carolina29607-
The University of Texas Health Science Center at HoustonBellaireTexas77401-
Dallas Diabetes Research CenterDallasTexas75230-
North Texas Endocrine CenterDallasTexas75231-
Biopharma Informatic, LLCHoustonTexas77043-
North Hills Family Medicine/North Hills Medical ResearchNorth Richland HillsTexas76180-
Clinical Trials of Texas, Inc.San AntonioTexas78229-
Northwest Houston Heart CenterTomballTexas77375-
Health Research of Hampton Roads, Inc.Newport NewsVirginia23606-
Capital Clinical Research CenterOlympiaWashington98502-
Rainier Clinical Research CenterRentonWashington98057-

Find similar trials in Pelham, AL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Cahaba Research· Pelham, ALScripps Memorial Hospital La Jolla· La Jolla, CANational Research Institute - Wilshire· Los Angeles, CANational Research Institute· Panorama City, CAArtemis Institute for Clinical Research· San Diego, CAUniversity Clinical Investigators, Inc.· Tustin, CA

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