Orforglipron for Obesity

Recruiting at 88 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

1200 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this Master Protocol is to support two studies to see how well and how safely orforglipron works compared to placebo in participants who have obesity or overweight with or without type 2 diabetes. Participants will be screened for about 4 weeks, after which they will enroll into either J2A-MC-GZP1, NCT06972459 (do not have type 2 diabetes) or J2A-MC-GZP2, NCT06972472 (have type 2 diabetes).

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 clinical trial is open to individuals who are overweight or obese, with some participants also having type 2 diabetes. There aren't specific eligibility criteria for the master protocol, meaning a broad range of people could potentially participate.

Inclusion Criteria

There are no specific eligibility criteria for the Master Protocol.

Exclusion Criteria

There are no specific eligibility criteria for the Master Protocol.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive orforglipron or placebo orally

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Orforglipron

Trial Overview The trial is testing Orforglipron against a placebo in two separate studies under one master protocol. One study includes those without type 2 diabetes and the other includes those with it, assessing how effective and safe Orforglipron is for weight management.

Participant Groups

Group I: Orforglipron Dose 4 (Study GZP2) Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group II: Orforglipron Dose 4 (Study GZP1) Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group III: Orforglipron Dose 3 (Study GZP2) Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group IV: Orforglipron Dose 3 (Study GZP1) Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group V: Orforglipron Dose 2 (Study GZP2) Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group VI: Orforglipron Dose 2 (Study GZP1) Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group VII: Orforglipron Dose 1 (Study GZP2) Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group VIII: Orforglipron Dose 1 (Study GZP1) Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group IX: Placebo (Study GZP1) Placebo Group 1 Intervention

Participants will receive placebo orally

Group X: Placebo (Study GZP2) Placebo Group 1 Intervention

Participants will receive placebo orally

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University