What side effects are associated with this type of intervention?

Common treatments for obesity, particularly GLP-1 receptor agonists like Orforglipron, often have side effects that include gastrointestinal symptoms such as nausea, vomiting, and diarrhea. There are also concerns about the potential risk of pancreatitis and pancreatic cancer, although these risks are still being studied. Additionally, some GLP-1 receptor agonists have been associated with benign and malignant thyroid C cell tumors in rodent studies, but this effect has not been clearly demonstrated in humans. Other side effects may include injection site reactions and, less commonly, gallbladder-related issues such as cholelithiasis.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of obesity. Liraglutide (Saxenda) is one such drug, which has shown significant weight loss in clinical trials, with patients losing an average of 8.0 kg compared to 2.6 kg with placebo over 56 weeks. Another GLP-1 receptor agonist, semaglutide, has also been approved for weight management, demonstrating substantial efficacy in reducing body weight. These drugs not only aid in weight loss but also improve cardiometabolic risk factors and glycemic control, making them effective options for patients with obesity and type 2 diabetes.

What other types of research exist?

Promising alternatives to Orforglipron for obesity treatment in 2024 include: 1) Semaglutide, which has shown significant weight loss benefits in clinical trials. 2) Tirzepatide, a dual GIP and GLP-1 receptor agonist, which has demonstrated superior efficacy in weight reduction compared to other GLP-1 receptor agonists. 3) Liraglutide, which is already approved for weight management and has a strong safety profile.

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Orforglipron for Obesity (ATTAIN-2 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 a diagnosis of Type 2 Diabetes (T2D), with HbA1c ≥7% (≥53 mmol/mol) to ≤10% (86 mmol/mol) and are on stable treatment for T2D for at least 90 days prior to screening, consisting of either diet/exercise alone or up to 3 oral antihyperglycemic medications (excluding dipeptidyl peptidase IV inhibitors (DPP-4i) or glucagon-like peptide-1 (GLP-1) receptor agonists (RA)).

Be older than 18 years old

Must not have

Have had a history of chronic or acute pancreatitis.

Have family (first-degree relative) or personal history of medullary thyroid cancer (MTC) or multiple endocrine neoplasia 2 (MEN2) syndrome.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

Summary

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.

Who is the study for?

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.

What is being tested?

The 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.

What are the potential side effects?

While the specific side effects of Orforglipron are not listed here, common side effects from weight loss drugs can include digestive issues like nausea or constipation, headaches, dry mouth, fatigue and sometimes more serious reactions depending on individual health conditions.

Eligibility Criteria

Inclusion Criteria

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

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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.

Exclusion Criteria

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

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I have a history of pancreatitis.

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

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I have Type 1 Diabetes or a history of severe diabetic complications.

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I have lost or gained more than 11 pounds in the last 3 months.

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 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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Orforglipron

2024

Completed Phase 1

~80

0 / 5Eligibility 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, which is naturally released after meals. They enhance insulin secretion, inhibit glucagon release, slow gastric emptying, and increase feelings of fullness, leading to reduced food intake and weight loss. These mechanisms are significant for obesity patients as they help manage weight and improve metabolic health, thereby reducing the risk of obesity-related complications like type 2 diabetes and cardiovascular diseases.