Orforglipron for Obesity

Recruiting at 3 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Weight loss medications

Disqualifiers: Diabetes, Unstable weight, Hepatitis, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 months

120 Participants Needed

Trial Summary

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

The trial requires that you stop taking any medications or alternative remedies used to manage weight loss.

What data supports the effectiveness of the drug Orforglipron for obesity?

Research shows that Orforglipron, a drug taken once daily, helps with weight loss in adults with obesity. It has also been studied for type 2 diabetes, where it showed effectiveness compared to a placebo. ^{1 2 3 4 5}

Is orforglipron safe for humans?

Orforglipron has been studied for safety in people with obesity and type 2 diabetes, showing it is generally safe for human use. However, as with any medication, there may be side effects, and it's important to discuss these with a healthcare provider. ^{1 2 3 6 7}

How is the drug Orforglipron different from other obesity treatments?

Orforglipron is unique because it is a once-daily oral medication that acts as a glucagon-like peptide-1 (GLP-1) receptor agonist, which is different from many other obesity treatments that are often injectable. This makes it more convenient for people who prefer not to use injections. ^{1 2 3 6 8}

What is the purpose of this trial?

The main purpose of this study is to see how orforglipron affects the amount of body fat compared with placebo in participants with obesity or overweight. Participation in the study will last approximately 8 months.

Research Team

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 : Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Eligibility Criteria

This trial is for adults with obesity or overweight who are interested in testing a new drug, Orforglipron. Participants will be involved in the study for about 8 months.

Inclusion Criteria

Have a Body Mass Index (BMI) of ≥30.0 kilograms per square meter (kg/m2)

Have a Body Mass Index (BMI) of ≥27.0 kg/m2 with comorbidities

Exclusion Criteria

I am using medication or remedies for weight loss.

I have diabetes and/or a history of severe diabetic complications.

Have an unstable body weight within 90 days prior to screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive orforglipron or placebo orally to assess the effect on body composition

8 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Orforglipron

Trial Overview The study aims to compare the effects of a new medication called Orforglipron against a placebo (a substance with no active drug) on reducing body fat in obese or overweight individuals.

Participant Groups

Group I: Orforglipron Experimental Treatment 1 Intervention

Participants will receive orforglipron orally

Group II: 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

Findings from Research

In a phase 2 trial involving 272 adults with obesity, the oral GLP-1 receptor agonist orforglipron resulted in significant weight loss, with participants losing between 8.6% to 14.7% of their body weight by week 36, compared to only 2.3% in the placebo group.

Orforglipron was generally well-tolerated, with mild to moderate gastrointestinal side effects being the most common adverse events, leading to discontinuation in 10-17% of participants, similar to the safety profile of injectable GLP-1 receptor agonists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. Wharton, S., Blevins, T., Connery, L., et al.[2023]

In a 26-week phase 2 trial involving 383 participants with type 2 diabetes, orforglipron significantly reduced HbA1c levels by up to -2.10% compared to placebo and showed greater weight loss of up to -10.1 kg, indicating its efficacy as a treatment option.

The safety profile of orforglipron was comparable to other GLP-1 receptor agonists, with most adverse events being mild to moderate gastrointestinal issues, suggesting it may be a safer and more convenient alternative to injectable treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. Frias, JP., Hsia, S., Eyde, S., et al.[2023]

A study involving adults with obesity demonstrated that the daily oral GLP-1 receptor agonist orforglipron effectively aids in weight loss, showcasing its potential as a treatment option for obesity.

The findings suggest that orforglipron may offer a convenient oral alternative to traditional injectable GLP-1 receptor agonists, enhancing patient adherence to obesity management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

In obesity or overweight without diabetes, orforglipron increased weight loss at 26 wk. Lau, D.[2023]

Modest weight loss of about 5% through dietary changes and increased activity can significantly reduce the risk of obesity-related diseases and delay the onset of type 2 diabetes in patients with a BMI of 27 or higher.

Weight loss medications can enhance adherence to lifestyle changes and lead to meaningful improvements in health outcomes, but careful selection and understanding of the benefits and risks of these medications are essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of weight loss drugs. Wittert, G., Caterson, I., Finer, N.[2014]

A study involving over 28,000 patients found that orlistat and sibutramine have different safety profiles, with orlistat primarily causing gastrointestinal issues like diarrhea, while sibutramine was associated with central nervous system effects and hypertension.

The findings from prescription-event monitoring (PEM) were consistent with published case reports, confirming that the adverse events linked to these medications align with their distinct mechanisms of action.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The safety profiles of orlistat and sibutramine: results of prescription-event monitoring studies in England. Perrio, MJ., Wilton, LV., Shakir, SA.[2021]

References

1. United States pubmed.ncbi.nlm.nih.gov

Daily Oral GLP-1 Receptor Agonist Orforglipron for Adults with Obesity. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Efficacy and safety of oral orforglipron in patients with type 2 diabetes: a multicentre, randomised, dose-response, phase 2 study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

In obesity or overweight without diabetes, orforglipron increased weight loss at 26 wk. [2023]

4. India pubmed.ncbi.nlm.nih.gov

The new role of pharmacotherapy for weight reduction in obesity. [2018]

5. Netherlands pubmed.ncbi.nlm.nih.gov

The clinical effectiveness of weight loss drugs. [2014]

6. United States pubmed.ncbi.nlm.nih.gov

Safety and efficacy of the new, oral, small-molecule, GLP-1 receptor agonists orforglipron and danuglipron for the treatment of type 2 diabetes and obesity: systematic review and meta-analysis of randomized controlled trials. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

The safety profiles of orlistat and sibutramine: results of prescription-event monitoring studies in England. [2021]

8. Brazil pubmed.ncbi.nlm.nih.gov

Safety and efficacy of fenproporex for obesity treatment: a systematic review. [2018]