A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes

Part of paid clinical trials in Sun City West, Arizona.

Sponsor
Eli Lilly and Company
Study ID
NCT06993792
Phase
PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Orforglipron — DRUG
    Administered orally
  • Placebo — DRUG
    Administered orally

Study Details

The purpose of this Master Protocol is to support two studies to see how well and how safely orforglipron works compared to placebo in participants who have obesity or overweight with or without type 2 diabetes. Participants will be screened for about 4 weeks, after which they will enroll into either J2A-MC-GZP1, NCT06972459 (do not have type 2 diabetes) or J2A-MC-GZP2, NCT06972472 (have type 2 diabetes).

Key Dates

Start date
May 15, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
1,200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING

Arms

  • Experimental: Orforglipron Dose 1 (Study GZP1)
    Participants will receive orforglipron orally
  • Experimental: Orforglipron Dose 2 (Study GZP1)
    Participants will receive orforglipron orally
  • Experimental: Orforglipron Dose 3 (Study GZP1)
    Participants will receive orforglipron orally
  • Experimental: Orforglipron Dose 4 (Study GZP1)
    Participants will receive orforglipron orally
  • Placebo Comparator: Placebo (Study GZP1)
    Participants will receive placebo orally
  • Experimental: Orforglipron Dose 1 (Study GZP2)
    Participants will receive orforglipron orally
  • Experimental: Orforglipron Dose 2 (Study GZP2)
    Participants will receive orforglipron orally
  • Experimental: Orforglipron Dose 3 (Study GZP2)
    Participants will receive orforglipron orally
  • Experimental: Orforglipron Dose 4 (Study GZP2)
    Participants will receive orforglipron orally
  • Placebo Comparator: Placebo (Study GZP2)
    Participants will receive placebo orally

Primary Outcome Measure

Number of Participants Allocated to Each Study [ Time Frame: Baseline to Week 4 ]

Locations (35)

FacilityCityStateZIPSite coordinators
Clinical Research Institute of Arizona (CRI) - Sun City WestSun City WestArizona85375-
Novak Clinical Research - Tucson - North La Cholla BoulevardTucsonArizona85741-
Norcal Endocrinology & Internal MedicineSan RamonCalifornia94583-
Southern California Clinical ResearchSanta AnaCalifornia92701-
Care Access - Thousand OaksThousand OaksCalifornia91360-
Accel Research Sites - DeLand Clinical Research UnitDeLandFlorida32720-
Innovation Medical Research Center - Fort LauderdaleFort LauderdaleFlorida33316-
Indago Research & Health Center, IncHialeahFlorida33012-
Encore Medical ResearchHollywoodFlorida33024-
West Orange Endocrinology P.A.OcoeeFlorida34761-
Care Access - TampaTampaFlorida33625-
Conquest ResearchWinter ParkFlorida32789-
Accel Research Sites - NeuroStudies Clinical Research UnitDecaturGeorgia30030-
Care Access - DecaturDecaturGeorgia30030-
Javara - Privia Medical Group Georgia - SavannahSavannahGeorgia31406-
North Georgia Clinical ResearchWoodstockGeorgia30189-
Solaris Clinical ResearchMeridianIdaho83646-
Care Access - New IberiaNew IberiaLouisiana70560-
Endocrine and Metabolic ConsultantsRockvilleMaryland20852-
Javara - Privia Medical Group - Silver SpringSilver SpringMaryland20901-
Great Lakes Research Group, Inc.Bay CityMichigan48706-
Boeson Research MSOMissoulaMontana59804-
Javara - Nevada Health Centers - Carson CityCarson CityNevada89706-
The Machuca FoundationLas VegasNevada89101-
University of North Carolina Medical CenterChapel HillNorth Carolina27514-
Javara - Tryon Medical PartnersCharlotteNorth Carolina28210-
Care Access - FayettevilleFayettevilleNorth Carolina28314-
The Corvallis Clinic, P.C.CorvallisOregon97330-
Clinical Research of PhiladelphiaPhiladelphiaPennsylvania19114-
Frontier Clinical Research, LLCSmithfieldPennsylvania15478-
Velocity Clinical Research, DallasDallasTexas75230-
Biopharma Informatic, LLCHoustonTexas77043-
Activian Clinical ResearchKingwoodTexas77339-
Texas Valley Clinical Research (TVCR) - MissionMissionTexas78572-
Consano Clinical Research, LLCShavano ParkTexas78231-

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