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 such as gastrointestinal symptoms (nausea, vomiting, diarrhea), and potential risks of pancreatitis and thyroid C cell tumors. Other obesity treatments, such as orlistat, can cause gastrointestinal issues like increased fecal fat excretion and oily stools. Phentermine-topiramate combinations may lead to side effects including dry mouth, constipation, and insomnia. It is important to discuss these potential side effects with a healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several GLP-1 receptor agonists for the treatment of obesity. Liraglutide (Saxenda) was approved for chronic weight management in adults with a BMI of 30 kg/m2 or greater, or 27 kg/m2 or greater with at least one weight-related condition, such as hypertension or type 2 diabetes. Another GLP-1 receptor agonist, semaglutide (Wegovy), was also approved for weight management in similar patient populations. These drugs have shown significant efficacy in weight loss and improvement in cardiometabolic risk factors.

What other types of research exist?

Promising alternatives to Orforglipron for obesity treatment in 2024 include: 1) Liraglutide, a GLP-1 receptor agonist approved for weight management, which has demonstrated cardiovascular safety. 2) Semaglutide, another GLP-1 receptor agonist, which has shown significant weight loss and cardiovascular benefits. 3) Naltrexone/Bupropion combination therapy, which has been effective in weight loss and managing obesity-related risk factors. These alternatives have been supported by clinical trials and recent studies.

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Orforglipron for Obesity (ATTAIN-1 Trial)

Phase 3

Recruiting

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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, week 72

Awards & highlights

Pivotal Trial

Summary

This trial will test the safety and effectiveness of an oral medication called orforglipron in adults who are obese or overweight and have related health problems. The medication aims to help reduce body weight by possibly affecting appetite or metabolism.

Who is the study for?

This trial is for adults with obesity or overweight who also have weight-related health issues like high blood pressure, sleep apnea, heart disease, or high cholesterol. Participants should have a BMI of 30 or higher and a history of unsuccessful dieting to lose weight.

What is being tested?

The study is testing Orforglipron, an oral medication taken once daily, against a placebo to see if it's effective and safe in helping people with obesity or overweight reduce their body weight.

What are the potential side effects?

While the specific side effects are not listed here, common side effects for weight loss drugs can include digestive issues such as nausea and constipation, headaches, dizziness, dry mouth, and potential changes in mood.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, week 72

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, week 72

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 72 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mean Percent Change from Baseline in Body Weight

Secondary study objectives

Mean Change from Baseline in Diastolic Blood Pressure (DBP)

Mean Change from Baseline in Fasting Glucose

Mean Change from Baseline in Hemoglobin A1c (HbA1c) %

+6 more

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

Participant will receive orforglipron administered orally.

Group II: Orforglipron Dose 2Experimental Treatment1 Intervention

Participant will receive orforglipron administered orally.

Group III: Orforglipron Dose 1Experimental Treatment1 Intervention

Participant will receive orforglipron administered orally.

Group IV: PlaceboPlacebo Group1 Intervention

Participants will be given placebo.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Orforglipron

2024

Completed Phase 1

~80

Do I qualify?Apply below to find out

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 those similar to Orforglipron, mimic the incretin hormone GLP-1, which is naturally released after eating. They enhance insulin secretion, reduce glucagon levels, slow gastric emptying, and increase feelings of fullness. These actions collectively help reduce food intake and promote weight loss, making them effective for managing obesity by addressing both metabolic and appetite-related factors.