Orforglipron vs Dulaglutide for Type 2 Diabetes

(ACHIEVE-PEDS Trial)

Not yet recruiting at 70 trial locations
Tq
Pi
Overseen ByPhysicians interested in becoming principal investigators please contact
Age: < 18
Sex: Any
Trial Phase: Phase 3
Sponsor: Eli Lilly and Company
Must be taking: Metformin, Basal insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This study looks at how well a medicine called orforglipron works compared to another medicine called dulaglutide in pediatric participants aged 10 to less than 18 years with type 2 diabetes. The study will also check how safe these medicines are and how the body processes them.

Participation in the study will last about 61 weeks.

Who Is on the Research Team?

C1

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for children and teens aged 10 to under 18 years who have type 2 diabetes. Participants should be otherwise healthy enough to take part, as determined by the study team.

Inclusion Criteria

Have a body weight ≥50 kilograms (110 pounds) and a body mass index (BMI) of >85th percentile
Have HbA1c > 6.5% to ≤ 11.0% at screening
I have type 2 diabetes managed with diet, exercise, metformin, or basal insulin.

Exclusion Criteria

I have type 1 diabetes.
I have used weight loss medications in the past 90 days.
I have had pancreatitis or gallbladder disease in the past.
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either orforglipron orally or dulaglutide subcutaneously

57 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Trial Overview

The study compares two medicines—Orforglipron (a new oral drug) and Dulaglutide (an injectable medicine)—to see which works better and is safer for treating type 2 diabetes in young people over about a year.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: OrforglipronExperimental Treatment1 Intervention
Group II: DulaglutideActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University