A Study of Tirzepatide (LY3298176) in Participants With Obesity or Overweight With Weight Related Comorbidities

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Eli Lilly and Company
Study ID
NCT05822830
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The main purpose of this phase 3b study is to evaluate the efficacy and safety of tirzepatide compared with semaglutide in adult participants who have obesity or overweight with weight related comorbidities without Type 2 Diabetes. The study will last around 74 weeks.

Key Dates

Start date
Apr 21, 2023
Status verified
Nov 2025
Primary completion
Nov 13, 2024
Completion
Nov 13, 2024

Study Design

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

Arms

  • Experimental: 15 mg or MTD - Tirzepatide
    Participants received a starting dose of 2.5 milligrams (mg) tirzepatide administered subcutaneously (SC) once weekly (QW) for 4 weeks, then the dose was increased by 2.5 mg every 4 weeks (2.5 to 5 to 7.5 to 10 to 12.5 to 15 mg) up to 15 mg QW or maximum tolerated dose \[MTD (10 mg or 15 mg)\] until Week 72.
  • Active Comparator: 2.4 mg or MTD - Semaglutide
    Participants received a starting dose of 0.25 mg semaglutide administered SC QW for 4 weeks, then the dose was increased every 4 weeks (0.25 to 0.5 to 1.0 to 1.7 to 2.4 mg) up to 2.4 mg QW or MTD (1.7 mg or 2.4 mg) until Week 72.

Primary Outcome Measure

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

Locations (30)

FacilityCityStateZIPSite coordinators
Cahaba ResearchBirminghamAlabama35242-
Cahaba Research - PelhamPelhamAlabama35124-
Southern California Dermatology, Inc.Santa AnaCalifornia92701-
Encompass Clinical ResearchSpring ValleyCalifornia91978-
University Clinical Investigators, Inc.TustinCalifornia92780-
Velocity Clinical Research, Hallandale BeachHallandaleFlorida33009-
New Horizon Research CenterMiamiFlorida33165-
ForCare Clinical ResearchTampaFlorida33613-1244-
Rophe Adult and Pediatric Medicine/SKYCRNGUnion CityGeorgia30291-
Rocky Mountain Clinical ResearchIdaho FallsIdaho83404-
Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowa50265-
L-MARC Research CenterLouisvilleKentucky40213-
Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroyMichigan48098-
Prime Health and Wellness/SKYCRNGFayetteMississippi39069-
StudyMetrix ResearchCity of Saint PetersMissouri63303-
Palm Research Center SunsetLas VegasNevada89148-
Palm Research Center TenayaLas VegasNevada89128-
Weill Cornell Medical CollegeNew YorkNew York10021-
PharmQuestGreensboroNorth Carolina27408-
Lillestol ResearchFargoNorth Dakota58104-
Alliance for Multispecialty Research, LLCNormanOklahoma73069-
Tribe Clinical Research, LLCGreenvilleSouth Carolina29607-
WR-Clinsearch, LLCChattanoogaTennessee37421-
The University of Texas Health Science Center at HoustonBellaireTexas77401-
Dallas Diabetes Research CenterDallasTexas75230-
North Texas Endocrine CenterDallasTexas75231-
Biopharma Informatic, LLCHoustonTexas77043-
PlanIt Research, PLLCHoustonTexas77079-
Southern Endocrinology AssociatesMesquiteTexas75149-
Pinnacle Clinical ResearchSan AntonioTexas78229-

Related coverage on Hipa.ai

Find similar trials in Birmingham, AL

By condition
Obesity / overweight
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Cahaba Research· Birmingham, ALCahaba Research - Pelham· Pelham, ALSouthern California Dermatology, Inc.· Santa Ana, CAEncompass Clinical Research· Spring Valley, CAUniversity Clinical Investigators, Inc.· Tustin, CAVelocity Clinical Research, Hallandale Beach· Hallandale, FL

Related Studies