Orforglipron for Type 2 Diabetes and Obesity
(ACHIEVE-4 Trial)

Recruiting in Palo Alto (17 mi)

+467 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial is testing a new diabetes medication called orforglipron to see if it is safer and more effective than insulin in people with type 2 diabetes who are overweight or obese and at higher risk for heart problems. The study will last several years and involve multiple visits.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for adults with type 2 diabetes and obesity or overweight, who also have a higher risk of heart disease. Participants should not be on insulin therapy but may be taking other diabetes medications.

Treatment Details

Interventions

Insulin Glargine (Hormone Therapy)
Orforglipron (Other)

Trial OverviewThe study tests the safety and effectiveness of a daily oral medication called Orforglipron compared to Insulin Glargine, an injectable insulin, over about two years with up to 27 visits.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: OrforglipronExperimental Treatment1 Intervention

Participants will receive escalated doses of orforglipron orally.

Group II: Insulin GlargineActive Control1 Intervention

Participants will receive insulin glargine subcutaneously (SC). Doses will be individualized and titrated according to a treat-to-target algorithm.

Insulin Glargine is already approved in Canada, Japan, China, Switzerland for the following indications: