Orforglipron for Obesity

Recruiting at 105 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Weight loss medications

Disqualifiers: Diabetes, Unstable weight, Heart failure, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 72 weeks

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called orforglipron to determine its effectiveness in weight loss. Participants will receive either varying doses of orforglipron or a placebo (a pill with no active ingredient) for comparison. The trial targets individuals who are obese or overweight and have conditions like high blood pressure or sleep apnea, but not diabetes. Ideal candidates are those who have previously attempted and failed to lose weight through dieting. As a Phase 3 trial, this study represents the final step before FDA approval, providing participants an opportunity to contribute to the potential availability of a new weight-loss treatment.

Do I need to stop my current medications for the trial?

The trial requires that you stop taking any medications or alternative remedies for weight loss.

Is there any evidence suggesting that orforglipron is likely to be safe for humans?

Research has shown that orforglipron has been tested in adults with obesity and has demonstrated promising safety results. One study found that after 72 weeks of treatment, participants taking orforglipron lost more weight than those taking a placebo (a pill with no active medicine). Importantly, the side effects were similar to those seen with other treatments in this category.

This indicates that orforglipron was generally well-tolerated. Common side effects were mild and might include nausea or diarrhea, similar to those experienced with other obesity treatments.

The fact that orforglipron is in a late stage of trials suggests strong evidence of its safety for humans. While all medicines can have side effects, those associated with orforglipron are similar to those expected from other weight-loss medications. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about orforglipron for obesity because it offers a new oral treatment option that targets weight loss. Unlike many current treatments, which often involve injections, orforglipron is taken orally, making it more convenient for users. This drug works by mimicking a hormone that regulates appetite and metabolism, potentially leading to significant weight loss. Its oral delivery and distinct mechanism of action differentiate it from existing options like GLP-1 receptor agonists, promising a more accessible and potentially more effective approach to managing obesity.

What evidence suggests that orforglipron could be an effective treatment for obesity?

Research has shown that orforglipron, a pill, can significantly aid weight loss in people with obesity. In one study, participants taking orforglipron lost an average of up to 12.4% of their body weight over 72 weeks, primarily from fat rather than muscle. In this trial, participants will receive varying doses of orforglipron or a placebo. Another study found that orforglipron resulted in greater weight loss than a placebo, with up to a 7.9% reduction in body weight at the highest dose. These findings suggest orforglipron could be a valuable option for weight management. ^{1 2 4 6 7}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

This trial is for individuals who are overweight or have obesity, along with another weight-related health issue (but not type 2 diabetes). Participants will be involved in the study for about 18 months.

Inclusion Criteria

Have a history of at least one unsuccessful dietary effort to lose body weight

My BMI is over 25 and I have a weight-related health issue like high blood pressure or heart disease.

Exclusion Criteria

I have diabetes.

I have hepatitis or pancreatitis.

I am using medication or remedies for weight loss.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orforglipron or placebo orally to assess weight reduction

72 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Orforglipron

Trial Overview

The study is testing Orforglipron against a placebo to see if it can help reduce body weight. It's part of a larger research project and involves taking the medication or placebo over an extended period.

How Is the Trial Designed?

Group I: Orforglipron Dose 4 Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group II: Orforglipron Dose 3 Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group III: Orforglipron Dose 2 Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group IV: Orforglipron Dose 1 Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group V: Placebo Placebo Group 1 Intervention

Participants will receive placebo orally

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

1.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2511774

Orforglipron, an Oral Small-Molecule GLP-1 Receptor ...

In the pooled orforglipron groups, 73.1% of the body-weight reduction was due to a loss in fat mass and 26.9% was due to a loss in lean mass.

2.

investor.lilly.com

investor.lilly.com/news-releases/news-release-details/lillys-oral-glp-1-orforglipron-demonstrated-statistically

Lilly's oral GLP-1, orforglipron, demonstrated statistically ...

In an additional key secondary endpoint, participants taking orforglipron lost an average of 16.0 lbs (7.9%) at the highest dose. Given that ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40960239/

Orforglipron, an Oral Small-Molecule GLP-1 Receptor ...

Conclusions: In adults with obesity, 72-week treatment with orforglipron led to significantly greater reductions in body weight than placebo; ...

4.

news.weill.cornell.edu

news.weill.cornell.edu/news/2025/09/oral-glp-1-drug-orforglipron-promotes-substantial-weight-loss-in-clinical-trial

Oral GLP-1 Drug Orforglipron Promotes Substantial Weight ...

Over 72 weeks, patients in the low-, medium- and high-dose orforglipron groups lost an average of 7.8%, 9.3% and 12.4% of their initial body ...

5.

nature.com

nature.com/articles/d41591-025-00060-6

New GLP-1 drug delivers weight loss in a pill

Orforglipron resulted in significantly greater weight loss than placebo. After 72 weeks, mean weight reduction from baseline was –7.5% (6 mg ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05872620

A Study of Orforglipron in Adult Participants With Obesity or ...

This study will investigate the safety and efficacy of once daily oral treatment with orforglipron compared with placebo on body weight in adult ...

7.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2302392

Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults ...

Daily oral orforglipron, a nonpeptide GLP-1 receptor agonist, was associated with weight reduction. Adverse events reported with orforglipron were similar to ...