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

First listed
Aug 24, 2023
Start date
Sep 28, 2023
Status verified
Jun 2026
Primary completion
Jun 5, 2025
Completion
Jun 5, 2025

Study Design

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

Arms

  • Experimental: 3 mg Orforglipron
    Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by the maintenance dose of 3 mg for the remainder of the duration.
  • Experimental: 12 mg Orforglipron
    Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 12 mg at week 12, which was then continued for the remainder of the duration.
  • Experimental: 36 mg Orforglipron
    Participants received once-daily oral orforglipron for 52 weeks. Treatment began with a 1-mg loading dose for the first 4 weeks, followed by dose escalations every 4 weeks to reach the maintenance dose of 36 mg at week 20, which was then continued for the remainder of the duration.

Primary Outcome Measure

Number of Participants With Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Baseline to Week 54 ]

Related coverage on Hipa.ai

Find similar trials

Nationwide
Type 2 diabetes trialsEndocrinology trialsMetabolic health trialsWeight loss trials

Related Studies