1200 Participants Needed

Orforglipron for Obesity

Recruiting at 105 trial locations
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Overseen ByPhysicians interested in becoming principal investigators please contact
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Eli Lilly and Company
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called orforglipron, a medication for individuals with obesity or those who are overweight, with or without type 2 diabetes. The goal is to compare orforglipron to a placebo, a pill with no active ingredients, to evaluate its effectiveness and safety. Participants will be divided into groups to receive different doses of the treatment or a placebo. This trial may suit those who struggle with obesity or being overweight and frequently face weight-related issues, such as difficulty with physical activities. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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

The trial information does not specify if you need to stop your current medications. It's best to check the specific study criteria for more details.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that orforglipron is generally safe for people with obesity. Studies testing various doses, including 6 mg, 12 mg, and 36 mg, have demonstrated significant weight loss compared to a placebo. Side effects were similar to those of other treatments in the same category, suggesting that most people can use orforglipron without serious issues. The trial's late stage indicates that earlier research found the treatment to be relatively safe.12345

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

Orforglipron is unique because it offers a promising new approach to managing obesity. Unlike typical treatments that may involve invasive procedures or injections, Orforglipron is taken orally, making it more convenient for patients. Most current obesity treatments focus on reducing appetite or altering fat absorption, but Orforglipron works differently by targeting specific pathways in the body to help regulate metabolism more effectively. Researchers are excited about its potential to provide significant weight loss with fewer side effects and increased ease of use compared to existing options.

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

Research has shown that orforglipron helps people lose weight. In one study, participants taking orforglipron lost between 7.8% and 12.4% of their starting weight over 72 weeks, with 73.1% of this reduction being fat mass. Another study found that people lost up to 16 pounds on the highest dose. Overall, orforglipron led to significantly more weight loss than a placebo (a pill with no active ingredients). These results suggest orforglipron could be a promising option for managing obesity. Participants in this trial will receive different doses of orforglipron or a placebo to further evaluate its effectiveness.12467

Who Is on the Research Team?

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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 clinical trial is open to individuals who are overweight or obese, with some participants also having type 2 diabetes. There aren't specific eligibility criteria for the master protocol, meaning a broad range of people could potentially participate.

Inclusion Criteria

There are no specific eligibility criteria for the Master Protocol.

Exclusion Criteria

There are no specific eligibility criteria for the Master Protocol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive orforglipron or placebo orally

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 trial is testing Orforglipron against a placebo in two separate studies under one master protocol. One study includes those without type 2 diabetes and the other includes those with it, assessing how effective and safe Orforglipron is for weight management.
How Is the Trial Designed?
10Treatment groups
Experimental Treatment
Placebo Group
Group I: Orforglipron Dose 4 (Study GZP2)Experimental Treatment1 Intervention
Group II: Orforglipron Dose 4 (Study GZP1)Experimental Treatment1 Intervention
Group III: Orforglipron Dose 3 (Study GZP2)Experimental Treatment1 Intervention
Group IV: Orforglipron Dose 3 (Study GZP1)Experimental Treatment1 Intervention
Group V: Orforglipron Dose 2 (Study GZP2)Experimental Treatment1 Intervention
Group VI: Orforglipron Dose 2 (Study GZP1)Experimental Treatment1 Intervention
Group VII: Orforglipron Dose 1 (Study GZP2)Experimental Treatment1 Intervention
Group VIII: Orforglipron Dose 1 (Study GZP1)Experimental Treatment1 Intervention
Group IX: Placebo (Study GZP1)Placebo Group1 Intervention
Group X: Placebo (Study GZP2)Placebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials
2,708
Recruited
3,720,000+
Dr. Daniel Skovronsky profile image

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks profile image

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Citations

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.
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.govpubmed.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; ...
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 ...
New GLP-1 drug delivers weight loss in a pillOrforglipron resulted in significantly greater weight loss than placebo. After 72 weeks, mean weight reduction from baseline was –7.5% (6 mg ...
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 ...
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 ...
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