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

NCT06993792
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Participants
1,400
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Start date
2025-05-15
clinicaltrials.gov
Number of sites
80
clinicaltrials.gov

Summary
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).
clinicaltrials.gov
Short title
A Master Protocol for Orforglipron (LY3502970) in Participants With Obesity or Overweight With and Without Type 2 Diabetes
clinicaltrials.gov
Official title
A Master Protocol to Investigate the Efficacy and Safety of Orforglipron Tablet Once Daily Compared With Placebo in Participants With Obesity or Overweight With and Without Type 2 Diabetes
clinicaltrials.gov

Control arm
Placebo
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Active, not recruiting
clinicaltrials.gov
Phase
Phase 3
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2027-08-01
clinicaltrials.gov
First posted
2025-05-29
clinicaltrials.gov
Registry last updated
2026-07-31
clinicaltrials.gov
Primary completion date
2027-08-01
clinicaltrials.gov
Start date
2025-05-15
clinicaltrials.gov

Participants
1,400
clinicaltrials.gov
Participant count basis
Estimated
clinicaltrials.gov
Planned participants
1,400
clinicaltrials.gov
Protocol amendments
1
clinicaltrials.gov
Number of sites
80
clinicaltrials.gov

Data monitoring committee
No
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Eli Lilly and Company
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT06993792
clinicaltrials.gov
ClinicalTrials.gov ID
NCT06993792
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Parallel groups
Purpose
Screening
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
clinicaltrials.gov

  1. Number of Participants Allocated to Each Study

    Timeframe: Baseline to Week 4

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

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
Sources for eligibility
clinicaltrials.gov

  • Clinical Research Institute of Arizona (CRI) - Sun City WestSun City West, United States
  • Novak Clinical Research - Tucson - North La Cholla BoulevardTucson, United States
  • Norcal Endocrinology & Internal MedicineSan Ramon, United States
  • Southern California Clinical ResearchSanta Ana, United States
  • Care Access - Thousand OaksThousand Oaks, United States
  • Accel Research Sites - DeLand Clinical Research UnitDeLand, United States
  • Innovation Medical Research Center - Fort LauderdaleFort Lauderdale, United States
  • Indago Research & Health Center, IncHialeah, United States
  • Encore Medical ResearchHollywood, United States
  • West Orange Endocrinology P.A.Ocoee, United States
  • Care Access - TampaTampa, United States
  • Conquest ResearchWinter Park, United States
  • Accel Research Sites - NeuroStudies Clinical Research UnitDecatur, United States
  • Care Access - DecaturDecatur, United States
  • Javara - Privia Medical Group Georgia - SavannahSavannah, United States
  • North Georgia Clinical ResearchWoodstock, United States
  • Solaris Clinical ResearchMeridian, United States
  • Care Access - New IberiaNew Iberia, United States
  • Endocrine and Metabolic ConsultantsRockville, United States
  • Javara - Privia Medical Group - Silver SpringSilver Spring, United States
  • Great Lakes Research Group, Inc.Bay City, United States
  • Boeson Research MSOMissoula, United States
  • Javara - Nevada Health Centers - Carson CityCarson City, United States
  • The Machuca FoundationLas Vegas, United States
  • University of North Carolina Medical CenterChapel Hill, United States

And 55 more, listed on the interactive page.

Sources for sites
clinicaltrials.gov

  • 2025
  • 2025-521098-14-00
  • J2A-MC-GZPO
Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)

Targets (1)