A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes

Sponsor
Eli Lilly and Company
Study ID
NCT06010004
Phase
PHASE3
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

The purpose of this study is to determine the long-term safety of the study intervention orforglipron as a monotherapy or in combination with oral antihyperglycemic medication. This study includes 3 periods as follows: * screening and lead-in period: up to 4 weeks * treatment period: 52 weeks, including 20 weeks of dose escalation, and * safety follow-up period: 2 weeks.

Key Dates

Start date
Sep 28, 2023
Status verified
Jul 2025
Primary completion
Jun 5, 2025
Completion
Jun 5, 2025

Study Design

Enrollment
466 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Orforglipron Dose 1
    Participants will receive orforglipron administered orally.
  • Experimental: Orforglipron Dose 2
    Participants will receive orforglipron administered orally.
  • Experimental: Orforglipron Dose 3
    Participants will receive orforglipron administered orally.

Primary Outcome Measure

Number of Participants with Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline through Week 52 ]

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