A Study to Investigate Weight Management With LY3841136 and Tirzepatide (LY3298176), Alone or in Combination, in Adult Participants With Obesity or Overweight With Type 2 Diabetes

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT06603571
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • LY3841136 — DRUG
    Administered SC
  • Tirzepatide — DRUG
    Administered SC
  • Placebo — DRUG
    Administered SC

Study Details

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to investigate the safety and efficacy of LY3841136 for chronic weight management alone or in combination with Tirzepatide across a wide dose range in participants with Type 2 Diabetes. Participation in the study will last about 64 weeks.

Key Dates

Start date
Sep 20, 2024
Status verified
Sep 2025
Primary completion
Jun 30, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
350 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: LY3841136 Dose 1
    Participants will receive LY3841136 subcutaneously (SC)
  • Experimental: LY3841136 Dose 2
    Participants will receive LY3841136 SC
  • Experimental: LY3841136 Dose 3
    Participants will receive LY3841136 SC
  • Experimental: LY3841136 Dose 1 + Tirzepatide Dose 1
    Participants will receive LY3841136 SC and Tirzepatide SC
  • Experimental: LY3841136 Dose 2 + Tirzepatide Dose 1
    Participants will receive LY3841136 SC and Tirzepatide SC
  • Experimental: LY3841136 Dose 2 + Tirzepatide Dose 2
    Participants will receive LY3841136 SC and Tirzepatide SC
  • Experimental: LY3841136 Dose 3 + Tirzepatide Dose 3
    Participants will receive LY3841136 SC and Tirzepatide SC
  • Active Comparator: Tirzepatide Dose 3
    Participants will receive Tirzepatide SC
  • Experimental: LY3841136 Dose 2 + Tirzepatide Dose 3
    Participants will receive LY3841136 SC and Tirzepatide SC
  • Placebo Comparator: Placebo
    Participants will receive placebo administered SC.

Primary Outcome Measure

Percent Change from Baseline in Body Weight [ Time Frame: Baseline, Week 48 ]

Locations (48)

FacilityCityStateZIPSite coordinators
The Institute for Liver Health II dba Arizona Clinical Trials - MesaChandlerArizona85225-
HOPE Research InstitutePhoenixArizona85032-
Headlands Research - ScottsdaleScottsdaleArizona85260-
The Institute for Liver Health II dba Arizona Liver Health-TucsonTucsonArizona85712-
NorCal Medical Research, IncGreenbraeCalifornia94904-
Velocity Clinical Research, Huntington ParkHuntington ParkCalifornia90255-
Peninsula Research AssociatesRolling Hills EstatesCalifornia90274-
Diablo Clinical Research, Inc.Walnut CreekCalifornia94598-
Stamford Therapeutics ConsortiumStamfordConnecticut06905-
Northeast Research Institute (NERI)Fleming IslandFlorida32003-
Indago Research & Health Center, IncHialeahFlorida33012-
New Horizon Research CenterMiamiFlorida33165-
Suncoast Clinical Research, Inc.New Port RicheyFlorida34652-
Charter Research - Winter ParkOrlandoFlorida32803-
Charter Research - Lady LakeThe VillagesFlorida32162-
Medical Research PartnersAmmonIdaho83406-
Great Lakes Clinical Trials - AndersonvilleChicagoIllinois60640-
Great Lakes Clinical Trials - RavenswoodChicagoIllinois60640-
NorthShore University Health SystemSkokieIllinois60077-
Iowa Diabetes and Endocrinology Research CenterWest Des MoinesIowa50266-
Cotton O'Neil Diabetes & EndocrinologyTopekaKansas66606-
KnownwellNeedhamMassachusetts02492-
Lucida Clinical TrialsNew BedfordMassachusetts02740-
Headlands Research - DetroitSouthfieldMichigan48034-
Arcturus Healthcare , PLC, Troy Internal Medicine Research DivisionTroyMichigan48098-
StudyMetrix ResearchCity of Saint PetersMissouri63303-
Clinvest Headlands LlcSpringfieldMissouri65807-
Las Vegas Medical ResearchLas VegasNevada89128-
Dent Neurologic InstituteAmherstNew York14226-
Velocity Clinical Research, SyracuseEast SyracuseNew York13057-
North Suffolk NeurologyPort Jefferson StationNew York11776-
Rochester Clinical Research, LLCRochesterNew York14609-
Medication ManagementGreensboroNorth Carolina27405-
Monroe Biomedical ResearchMonroeNorth Carolina28112-
Lucas Research, IncMorehead CityNorth Carolina28557-
Lucas Research, Inc.New BernNorth Carolina28562-
CTI Clinical Research CenterCincinnatiOhio45212-
Tribe Clinical Research, LLCGreenvilleSouth Carolina29607-
Quality Medical ResearchNashvilleTennessee37211-
IMA Clinical Research AustinAustinTexas78745-
FutureSearch Trials of DallasDallasTexas75251-
Velocity Clinical Research, DallasDallasTexas75230-
PlanIt Research, PLLCHoustonTexas77079-
Endeavor Clinical TrialsSan AntonioTexas78240-
Tekton Research - Fredericksburg RoadSan AntonioTexas78229-
Texas Valley Clinical ResearchWeslacoTexas78596-
Spectrum Medical, Inc.DanvilleVirginia24541-
Central Washington Health Services Association d/b/a Confluence HealthWenatcheeWashington98801-

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