Orforglipron for Type 2 Diabetes and 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

Must not be taking: Weight loss drugs

Disqualifiers: Type 1 diabetes, Heart failure, others

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

Duration: 16 months

600 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to see how orforglipron, compared with placebo, helps improve glycemic control in participants with obesity or with overweight and type 2 diabetes. This trial is part of the master protocol study J2A-MC-GZPO. Participation in the study will last about 18 months.

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 people who are overweight or have obesity, along with type 2 diabetes. Participants should be interested in a study that lasts about 18 months to improve their blood sugar control.

Inclusion Criteria

Have hemoglobin A1c (HbA1c) ≥7% and ≤10% at screening

Have a history of at least one unsuccessful dietary effort to lose body weight

Have body mass index (BMI) ≥25 kilograms per square meter (kg/m2) at screening

Exclusion Criteria

I have type 1 diabetes.

I have hepatitis or pancreatitis.

My weight has been stable for the last 3 months.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orforglipron or placebo orally to assess glycemic control

16 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

Treatment Details

Interventions

• Orforglipron

Trial Overview The study tests Orforglipron against a placebo to see if it's better at managing blood sugar levels in those with obesity or overweight and type 2 diabetes. It's part of a larger research project called J2A-MC-GZPO.

Participant Groups

Group I: Orforglipron Dose 4 Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group II: Orforglipron Dose 3 Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group III: Orforglipron Dose 2 Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group IV: Orforglipron Dose 1 Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group V: Placebo 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