What side effects are associated with this type of intervention?

GLP-1 receptor agonists, such as liraglutide, exenatide, and semaglutide, are commonly used treatments for Type 2 Diabetes. Known side effects include gastrointestinal symptoms like nausea and vomiting, which are most common during the initial months of therapy. There is also a potential risk for benign and malignant thyroid C cell tumors, although this has been observed primarily in rodent studies and remains unclear in humans. Additionally, these medications are not recommended for patients with a personal or family history of medullary thyroid cancer or multiple endocrine neoplasia 2A or 2B. Other side effects can include hypoglycemia, particularly when used in combination with other glucose-lowering agents.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of Type 2 Diabetes. Notable examples include exenatide (Byetta and Bydureon), liraglutide (Victoza), and dulaglutide (Trulicity). Exenatide was approved in both twice-daily and extended-release formulations, with the latter showing significant improvements in glycemic control. Liraglutide has been shown to improve glycemic control and cardiovascular outcomes, leading to its approval for both adults and children. Dulaglutide, administered once weekly, has also demonstrated efficacy in improving glycemic control. These drugs work by enhancing insulin secretion and inhibiting glucagon release, thereby lowering blood glucose levels.

What other types of research exist?

Promising novel alternatives to Orforglipron for Type 2 Diabetes patients include semaglutide, dulaglutide, and tirzepatide. These GLP-1 receptor agonists have demonstrated efficacy and safety in clinical trials. Additionally, sodium-glucose cotransporter-2 (SGLT2) inhibitors like tofogliflozin, which can be used in combination with GLP-1 receptor agonists, are also promising options.

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Orforglipron for Type 2 Diabetes (ACHIEVE-1 Trial)

Phase 3

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have Type 2 Diabetes

Be older than 18 years old

Must not have

Have New York Heart Association functional classification IV congestive heart failure.

Have acute or chronic pancreatitis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

This trial is testing a new medication called orforglipron to help adults with type 2 diabetes who can't control their blood sugar with diet and exercise alone. The medication aims to improve how the body manages sugar levels.

Who is the study for?

Adults with Type 2 Diabetes who haven't been able to control their blood sugar levels through diet and exercise alone can join. They should have a stable weight, a BMI of at least 23, and an HbA1c level between 7.0% to 9.5%. Participants shouldn't be on insulin or other diabetes medications for the last 90 days.

What is being tested?

The trial is testing Orforglipron against a placebo in adults with Type 2 Diabetes over approximately one year. The goal is to see if Orforglipron is safe and more effective than no treatment (placebo) in controlling blood sugar levels.

What are the potential side effects?

Possible side effects of Orforglipron are not detailed here but may include typical drug reactions such as nausea, headache, dizziness, or allergic reactions. Side effects will be closely monitored throughout the study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have Type 2 Diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have severe heart failure.

Select...

I have pancreatitis.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Orforglipron Dose 3Experimental Treatment1 Intervention

Participants will receive orforglipron orally.

Group II: Orforglipron Dose 2Experimental Treatment1 Intervention

Participants will receive orforglipron orally.

Group III: Orforglipron Dose 1Experimental Treatment1 Intervention

Participants will receive orforglipron orally.

Group IV: PlaceboPlacebo Group1 Intervention

Participants will receive placebo orally.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Orforglipron

2024

Completed Phase 1

~80

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

GLP-1 receptor agonists, such as Orforglipron, mimic the incretin hormone GLP-1 to enhance insulin secretion, inhibit glucagon release, slow gastric emptying, and promote satiety, leading to improved glycemic control and potential weight loss. This multifaceted approach is crucial for Type 2 Diabetes patients as it addresses several underlying issues of the disease. Other common treatments include metformin, which reduces hepatic glucose production and increases insulin sensitivity, and insulin therapy, which directly supplements insulin levels. These treatments collectively help manage blood glucose levels effectively.

Incretin therapies: highlighting common features and differences in the modes of action of glucagon-like peptide-1 receptor agonists and dipeptidyl peptidase-4 inhibitors.