Orforglipron for Type 2 Diabetes and Obesity

Recruiting at 102 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 drugs

Disqualifiers: Type 1 diabetes, 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: 16 months

600 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new drug, orforglipron, to determine its effectiveness in helping people with type 2 diabetes and obesity manage their blood sugar levels. Participants will receive varying doses of orforglipron or a placebo (a pill with no active medicine) to compare the effects. The trial suits individuals with type 2 diabetes who struggle with weight despite dieting and have stable blood sugar levels between 7% and 10%. As a Phase 3 trial, it represents the final step before FDA approval, providing participants an opportunity to contribute to a potentially groundbreaking treatment.

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

The trial requires that you stop taking any medications or alternative remedies specifically for weight loss. It does not specify if you need to stop other medications, so you should discuss this with the trial team.

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

Research has shown that orforglipron is generally safe for people. This treatment, a pill, helps lower blood sugar. Studies have tested it at different doses, and evidence indicates that taking 12 mg or more can significantly reduce blood sugar levels and aid in weight loss.

Regarding safety, trials have not identified any serious side effects directly linked to orforglipron. If side effects occur, they are usually mild and manageable. As with any medication, some common side effects may arise, but overall, research supports that orforglipron is safe for individuals with obesity or type 2 diabetes. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for type 2 diabetes?

Unlike most treatments for type 2 diabetes and obesity, which are typically injectable GLP-1 receptor agonists like semaglutide or liraglutide, Orforglipron is unique because it is taken orally. This new treatment targets the same GLP-1 receptor but offers the convenience of a pill, potentially improving adherence for patients who prefer not to use injections. Researchers are excited about Orforglipron because it combines the benefits of GLP-1 receptor activation with a more convenient delivery method, potentially making it a popular choice for managing these conditions.

What evidence suggests that orforglipron might be an effective treatment for type 2 diabetes and obesity?

Studies have shown that orforglipron effectively treats type 2 diabetes and obesity. Research indicates that orforglipron significantly lowers HbA1c levels, a measure of blood sugar, by 1.3% to 2.1% depending on the dose. In this trial, participants will receive one of several doses of orforglipron or a placebo. Specifically, patients taking orforglipron lost more weight compared to those on a placebo. This treatment targets GLP-1 receptors, which help control blood sugar and weight. Overall, the evidence supports orforglipron's potential to improve blood sugar control and aid in weight management. ^{1 2 3 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 people who are overweight or have obesity, along with type 2 diabetes. Participants should be interested in a study that lasts about 18 months to improve their blood sugar control.

Inclusion Criteria

Have hemoglobin A1c (HbA1c) ≥7% and ≤10% at screening

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

Have body mass index (BMI) ≥25 kilograms per square meter (kg/m2) at screening

Exclusion Criteria

I have type 1 diabetes.

I have hepatitis or pancreatitis.

My weight has been stable for the last 3 months.

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 glycemic control

16 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

What Are the Treatments Tested in This Trial?

Interventions

• Orforglipron

Trial Overview The study tests Orforglipron against a placebo to see if it's better at managing blood sugar levels in those with obesity or overweight and type 2 diabetes. It's part of a larger research project called J2A-MC-GZPO.

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

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 ... Orforglipron is the first small molecule GLP-1 to successfully complete a Phase 3 trial, lowering A1C by an average of 1.3% to 1.6% across doses.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37369232/

Efficacy and safety of oral orforglipron in patients with type ... The primary efficacy outcome The primary efficacy outcome was mean change in HbA1c from baseline with orforglipron versus placebo at week 26.

4. thecardiologyadvisor.com thecardiologyadvisor.com/news/orforglipron-significantly-lowers-hba1c-in-two-additional-t2d-trials/

Orforglipron Significantly Lowers HbA1c in Two Additional ... Findings based on efficacy estimand results showed significant reductions in HbA1c of 1.5%, 2.1% and 1.9% in the 3mg, 12mg, and 36mg ...

5. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/eli-lilly-orforglipron-superior-efficacy-multiple-trials-type-2-diabetes

Eli Lilly's Orforglipron Shows Superior Efficacy Across ... Orforglipron met primary and secondary endpoints in Phase III trials, showing significant A1C reduction and weight loss in type 2 diabetes ...

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. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673623013028

Efficacy and safety of oral orforglipron in patients with type ... The novel, oral, non-peptide GLP-1 receptor agonist orforglipron at doses of 12 mg or greater showed significant reductions in HbA 1c and bodyweight compared ...