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 — DRUGAdministered orally
- Placebo — DRUGAdministered 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)
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