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

Purpose

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).

Conditions

  • Obesity
  • Overweight
  • Type 2 Diabetes

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

Criteria

There are no specific eligibility criteria for the Master Protocol.

- See study GZP1 for eligibility criteria relevant to participants with obesity and
overweight without type 2 diabetes

- See study GZP2 for eligibility criteria relevant to participants with type 2
diabetes

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Phase 3b
Primary Purpose
Screening
Masking
Double (Participant, Investigator)

Arm Groups

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

Recruiting Locations

Novak Clinical Research - Tucson - North La Cholla Boulevard
Tucson 5318313, Arizona 5551752 85741

Norcal Endocrinology & Internal Medicine
San Ramon 5392593, California 5332921 94583
Contact:
925-552-5280

Southern California Clinical Research
Santa Ana 5392900, California 5332921 92701
Contact:
714-474-2173

Care Access - Thousand Oaks
Thousand Oaks 5402405, California 5332921 91360
Contact:
805-778-5143

Accel Research Sites - DeLand Clinical Research Unit
DeLand 4152890, Florida 4155751 32720
Contact:
205-757-8212

Innovation Medical Research Center - Fort Lauderdale
Fort Lauderdale 4155966, Florida 4155751 33316
Contact:
305-300-2695

Encore Medical Research
Hollywood 4158928, Florida 4155751 33024
Contact:
954-400-1725

West Orange Endocrinology P.A.
Ocoee 4166776, Florida 4155751 34761
Contact:
407-480-4830

Care Access - Tampa
Tampa 4174757, Florida 4155751 33625
Contact:
813-771-5980

Accel Research Sites - NeuroStudies Clinical Research Unit
Decatur 4191124, Georgia 4197000 30030

Care Access - Decatur
Decatur 4191124, Georgia 4197000 30030
Contact:
678-470-4394

Javara - Privia Medical Group Georgia - Savannah
Savannah 4221552, Georgia 4197000 31406
Contact:
912-355-4447

North Georgia Clinical Research
Woodstock 4231874, Georgia 4197000 30189
Contact:
678-494-5735

Solaris Clinical Research
Meridian 5600685, Idaho 5596512 83646
Contact:
208-288-0123

Care Access - New Iberia
New Iberia 4334971, Louisiana 4331987 70560
Contact:
813-851-0135

Endocrine and Metabolic Consultants
Rockville 4367175, Maryland 4361885 20852
Contact:
301-770-7373

Javara - Privia Medical Group - Silver Spring
Silver Spring 4369596, Maryland 4361885 20901
Contact:
301-593-6072

Boeson Research MSO
Missoula 5666639, Montana 5667009 59804
Contact:
406-763-8833

Javara - Nevada Health Centers - Carson City
Carson City 5501344, Nevada 5509151 89706

The Machuca Foundation
Las Vegas 5506956, Nevada 5509151 89101
Contact:
725-400-2550

University of North Carolina Medical Center
Chapel Hill 4460162, North Carolina 4482348 27514
Contact:
984-974-3004

Javara - Tryon Medical Partners
Charlotte 4460243, North Carolina 4482348 28210
Contact:
704-495-6334

Care Access - Fayetteville
Fayetteville 4466033, North Carolina 4482348 28314
Contact:
910-249-9855

The Corvallis Clinic, P.C.
Corvallis 5720727, Oregon 5744337 97330

Clinical Research of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19114
Contact:
215-676-6696

Frontier Clinical Research, LLC
Smithfield 4561301, Pennsylvania 6254927 15478
Contact:
724-569-8036

Velocity Clinical Research, Dallas
Dallas 4684888, Texas 4736286 75230

Biopharma Informatic, LLC
Houston 4699066, Texas 4736286 77043
Contact:
713-984-8200

Texas Valley Clinical Research (TVCR) - Mission
Mission 4711725, Texas 4736286 78572

Consano Clinical Research, LLC
Shavano Park 4728147, Texas 4736286 78231
Contact:
210-545-4900

Puerto Rico Health and Wellness Institute
Dorado 4564133, Puerto Rico 00646
Contact:
7877961049

Isis Clinical Research Center
Guaynabo 4565119, Puerto Rico 00968
Contact:
7874045252

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com