A Study of Orforglipron (LY3502970) in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone
Part of paid clinical trials in Sheffield, Alabama.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT05971940
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Orforglipron — DRUGAdministered orally
- Placebo — DRUGAdministered orally
Study Details
The main purpose of this study is to determine safety and efficacy of orforglipron compared with placebo in adult participants with type 2 diabetes and inadequate glycemic control with diet and exercise alone. The study will last approximately 54 weeks.
Key Dates
- Start date
- Aug 9, 2023
- Status verified
- Apr 2026
- Primary completion
- Apr 3, 2025
- Completion
- Apr 3, 2025
Study Design
- Enrollment
- 559 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Placebo Comparator: PlaceboParticipants received once daily (QD) doses of orforglipron-matching placebo capsules administered orally, over a period of 40 weeks.
- Experimental: 3 mg OrforglipronParticipants received orforglipron capsules administered orally QD, starting at 1 milligram (mg) and increasing by 1 mg every 4 weeks until reaching a targeted dose of 3 mg, which was then maintained up to week 40.
- Experimental: 12 mg OrforglipronParticipants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 12 mg, which was then maintained up to week 40.
- Experimental: 36 mg OrforglipronParticipants received orforglipron capsules administered orally QD, starting at 1 mg and increasing every 4 weeks until reaching a targeted dose of 36 mg, which was then maintained up to week 40.
Primary Outcome Measure
Change From Baseline in HbA1c [ Time Frame: Baseline, Week 40 ]
Locations (41)
Related coverage on Hipa.ai
- Orforglipron Phase 3 Trial Shows Significant HbA1c Reduction in Type 2 DiabetesOrforglipron · Apr 22, 2026 · ClinicalTrials.gov
- Orforglipron Phase 3 Trial for Type 2 Diabetes Reduces HbA1c by Up to 1.59%Orforglipron · Apr 3, 2025 · ClinicalTrials.gov
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