A Study of Tirzepatide Compared With Intensified Conventional Care in Adult Participants With Type 2 Diabetes
Part of paid clinical trials in Birmingham, Alabama.
- Sponsor
- Eli Lilly and Company
- Study ID
- NCT05433584
- Phase
- PHASE4
- Status
- Active Not Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Tirzepatide — DRUGAdministered SC
- Antihyperglycemic medication — DRUGAs prescribed
Study Details
This study aims to investigate the efficacy and safety of tirzepatide in participants with type 2 diabetes (T2D) compared to other existing treatment options when treatment is initiated early.
Key Dates
- Start date
- Aug 1, 2022
- Status verified
- Dec 2025
- Primary completion
- Oct 21, 2025
- Completion
- Nov 30, 2027
Study Design
- Enrollment
- 780 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: TirzepatideParticipants will receive tirzepatide at the maximum tolerated dose subcutaneously (SC)
- Active Comparator: Intensified Conventional Care DoseParticipants will receive an antihyperglycemic medication
Primary Outcome Measure
Change from Baseline in Hemoglobin A1c (HbA1c) [ Time Frame: Baseline, Week 104 ]
Locations (32)
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