Orforglipron for Obesity

Recruiting in Palo Alto (17 mi)

+7 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Eli Lilly and Company

Disqualifiers: Diabetes, Cardiovascular, Psychiatric, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to see how much of orforglipron (study drug) gets into the bloodstream and how long it takes the body to get rid of it when given as capsules compared to tablets in healthy overweight and obese participants. The safety and tolerability (side effects) of orforglipron when given as capsules and tablets will also be evaluated. The study will be conducted in two parts, with part A and B lasting up to approximately 25 and 22 weeks each respectively, including the screening period.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, since the study is for healthy participants, it's possible that taking certain medications might affect eligibility. Please consult with the study team for specific guidance.

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

Research shows that Orforglipron, a drug that helps control blood sugar, also increased weight loss in people with obesity over 26 weeks. ^{1 2 3 4 5}

Is orforglipron safe for humans?

Orforglipron has been studied for safety in people with type 2 diabetes and obesity. In these studies, it was generally well-tolerated, meaning most people did not experience serious side effects. ^{1 2 3 4 5}

What makes the drug Orforglipron unique for treating obesity?

Orforglipron is unique because it is an oral, non-peptide drug that targets the glucagon-like peptide-1 (GLP-1) receptor, which is different from many other obesity treatments that are injectable. This makes it more convenient for patients who prefer a pill over an injection. ^{1 2 3 4 5}

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 healthy adults who are overweight or obese. Participants will be given the study drug, Orforglipron, in two different forms: capsules and tablets. The trial aims to understand how the body absorbs and processes these forms.

Inclusion Criteria

Participants who are overtly healthy as determined by medical history and physical examination

I am committed to following the study's requirements for its entire duration.

Have venous access sufficient to allow for blood sampling

Exclusion Criteria

I have trouble swallowing pills.

Have hemoglobin A1c (HbA1c) level of 6.5 percent (%) or greater

I have had major depression or psychiatric issues in the past 2 years.

Treatment Details

Interventions

• Orforglipron (Other)

Trial Overview The focus of this study is on comparing the absorption into the bloodstream and elimination from the body of Orforglipron when administered as a tablet versus a capsule. It's divided into two parts, each lasting about 22-25 weeks including screening.

Participant Groups

Group I: Part B: BE (bioequivalence) study: Cohort 1 and 2: Orforglipron Experimental Treatment 1 Intervention

Participants will receive different sequences of orforglipron doses administered as either tablet (different dose levels) or capsule (test dose levels 1 to 6).

Group II: Part A: Relative bioavailability study: Cohort 1 and 2: Orforglipron Experimental Treatment 1 Intervention

Participants will receive different sequences of orforglipron doses administered as either tablet or capsule at different dose levels.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Anaheim Clinical Trials, LLC Anaheim, CA

Altasciences Company Inc. Overland Park, KS

Fortrea Clinical Research Unit Daytona Beach, FL

Collaborative Neuroscience Research, LLC Los Alamitos, CA

More Trial Locations

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2708

Patients Recruited

3,720,000+

References

1. 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]

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

Orforglipron (LY3502970), a novel, oral non-peptide glucagon-like peptide-1 receptor agonist: A Phase 1b, multicentre, blinded, placebo-controlled, randomized, multiple-ascending-dose study in people with type 2 diabetes. [2023]

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

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

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

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

5. England pubmed.ncbi.nlm.nih.gov

LY3437943, a novel triple GIP, GLP-1, and glucagon receptor agonist in people with type 2 diabetes: a phase 1b, multicentre, double-blind, placebo-controlled, randomised, multiple-ascending dose trial. [2022]