At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 546 enrolled
Drug / intervention
Orforglipron +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3, Randomized, Double-Blind Study to Investigate the Efficacy and Safety of Once Daily Oral Orforglipron Compared With Placebo in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Insulin Glargine, With or Without Metformin and/or SGLT-2 Inhibitor
In Brief
A Phase 3 clinical trial evaluating Orforglipron and Placebo for Type 2 Diabetes. Completed, enrolled 546 participants across 70 sites in 6 countries.
Detailed Summary
The main purpose of this study is to determine the safety and efficacy of orforglipron. Participants will have Type 2 Diabetes (T2D) and have inadequate glycemic control with insulin glargine with or without metformin and/or SGLT-2 (sodium-glucose cotransporter-2) inhibitor. The study will last about 46 weeks and may include up to 20 visits.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes
CountriesBrazil, China, Japan, Puerto Rico, Romania, United States
Collaborators--
Timeline
Phase 3CompletedFinished
202420252026
First PostedOct 2023
Enrollment StartNov 2023
Primary CompletionSep 2025
TodayJul 2026
First PostedOct 31, 2023
Enrollment StartNov 10, 2023
Primary CompletionSep 15, 2025
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 2.7 years ago
Interventions
Orforgliprondrug
Administered orally.
Placebodrug
Administered orally.