Orforglipron vs Semaglutide for Type 2 Diabetes
(ACHIEVE-3 Trial)

Recruiting in Palo Alto (17 mi)

+159 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?

The main purpose of this study is to assess efficacy and safety of orforglipron compared with oral semaglutide in participants with Type 2 diabetes and inadequate glycemic control with metformin.The study will last around 61 weeks.

Eligibility Criteria

This trial is for adults with Type 2 Diabetes who have been taking metformin consistently and haven't achieved desired blood sugar control. Participants should not have had any significant weight changes or started new diets or intense exercise programs recently. They can't join if they have Type 1 Diabetes, recent severe diabetes complications, certain cancers, high serum calcitonin levels, advanced heart failure, are undergoing treatment for diabetic eye disease, or have severely reduced kidney function.

Inclusion Criteria

I have been taking at least 1500 mg of metformin daily for the last 90 days.

Your long-term blood sugar level (HbA1c) is between 7.0% and 10.5%.

I have Type 2 Diabetes.

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Exclusion Criteria

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

I have been cancer-free or in remission for less than 5 years.

I have had a severe diabetic complication in the last 6 months.

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Treatment Details

Interventions

Orforglipron (GLP-1 Receptor Agonist)
Semaglutide (GLP-1 Receptor Agonist)

Trial OverviewThe study compares the effectiveness and safety of a new medication called Orforglipron to an existing drug named Semaglutide in managing blood sugar levels over approximately 61 weeks in people whose Type 2 Diabetes isn't well-controlled by metformin alone.

Participant Groups

4Treatment groups

Experimental Treatment

Active Control

Group I: Orforglipron Dose 2Experimental Treatment1 Intervention

Participants will receive orforglipron orally.

Group II: Orforglipron Dose 1Experimental Treatment1 Intervention

Participants will receive orforglipron orally.

Group III: Semaglutide Dose 1Active Control1 Intervention

Participants will receive semaglutide orally.

Group IV: Semaglutide Dose 2Active Control1 Intervention

Participants will receive semaglutide orally.