Ignite Creation Date:
2025-12-24 @ 9:07 PM
Ignite Modification Date:
2025-12-25 @ 6:58 PM
Study NCT ID:
NCT06010004
Status:
COMPLETED
Last Update Posted:
2025-07-14
First Post:
2023-08-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Long-term Safety Study of Orforglipron (LY3502970) in Participants With Type 2 Diabetes
Sponsor:
Eli Lilly and Company
Organization:
Study Overview
Official Title:
A Phase 3, Long-term Safety Study of LY3502970 in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Diet and Exercise Alone or in Combination With Oral Antihyperglycemic Medications (ACHIEVE-J)
Status:
COMPLETED
Status Verified Date:
2025-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACHIEVE-J
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| J2A-JE-GZPE | OTHER | Eli Lilly and Company | View |