Orforglipron for Obesity
(ATTAIN-2 Trial)

Recruiting in Palo Alto (17 mi)

+169 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Eli Lilly and Company

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This trial will test a daily pill called orforglipron to see if it helps people who are overweight or obese and have type 2 diabetes lose weight. The study will last over a year 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

Adults with obesity or overweight and type 2 diabetes are eligible for this trial. They must have tried to lose weight through dieting without success, have stable blood sugar levels on up to three oral diabetes medications (excluding certain types), and a BMI of at least 27.0 kg/m². Those with recent significant weight changes, Type 1 Diabetes, diabetic eye treatment plans, or a history/family history of specific thyroid cancers cannot participate.

Inclusion Criteria

I have Type 2 Diabetes with an HbA1c level between 7% and 10%, and have been on a stable treatment for at least 90 days.

I have Type 2 Diabetes with an HbA1c level between 7% and 10%, and have been on a stable treatment plan for at least 90 days.

You need to have a body mass index (BMI) of 27 or higher.

See 4 more

Exclusion Criteria

I have a history of pancreatitis.

I or a close family member have had medullary thyroid cancer or MEN2.

I am currently getting or planning to get treatment for eye problems related to diabetes.

See 2 more

Treatment Details

Interventions

Orforglipron (Other)
Placebo (Other)

Trial OverviewThe study is testing the safety and effectiveness of Orforglipron, an oral medication taken once daily for reducing body weight in adults with obesity/overweight and type 2 diabetes. Participants will be randomly assigned to receive either Orforglipron or a placebo over approximately 77 weeks with up to 22 visits.

Participant Groups

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Orforglipron Dose 3Experimental Treatment1 Intervention

Participants will receive orforglipron administered orally.

Group II: Orforglipron Dose 2Experimental Treatment1 Intervention

Participants will receive orforglipron administered orally.

Group III: Orforglipron Dose 1Experimental Treatment1 Intervention

Participants will receive orforglipron administered orally.

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive placebo