LY3549492 for Obesity

Recruiting at 2 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: GLP-1 analogs

Disqualifiers: Cushing's, Prader Willi, Hypertension, Heart failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial focuses on testing the safety and tolerance of a new drug, LY3549492, for individuals who are overweight or have obesity. Researchers aim to observe how the drug behaves in the body when administered in multiple doses over approximately 8 weeks. The trial seeks participants with a body mass index (BMI) between 25 and 45 who do not have obesity due to specific endocrine disorders, such as Cushing's syndrome. Participants should also have stable blood pressure and heart health. As a Phase 1 trial, participants will be among the first to help researchers understand how this new treatment works in people.

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

The trial information does not specify if you need to stop taking your current medications. However, if you have used glucagon-like peptide-1 (GLP-1) analogs or similar drugs in the last 3 months, you may not be eligible to participate.

Is there any evidence suggesting that LY3549492 is likely to be safe for humans?

Research shows that LY3549492 is under study to assess its safety and tolerability. Earlier studies examined healthy adults to understand the drug's effects in the body with repeated doses. Although detailed safety information from these studies isn't available yet, the early testing phase indicates that researchers are still gathering basic safety data. They closely monitor participants for any side effects or issues to ensure the drug's safety before advancing to more comprehensive testing. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LY3549492 for obesity because it offers a fresh approach by targeting biological pathways differently than current options like appetite suppressants or fat absorption blockers. While many existing treatments focus on managing caloric intake or fat absorption, LY3549492 works by engaging a novel mechanism that could potentially regulate metabolism more effectively. Its oral administration also promises convenience, which might improve adherence and outcomes for patients struggling with obesity.

What evidence suggests that LY3549492 might be an effective treatment for obesity?

Research has shown that LY3549492 is under study for its potential to address obesity and type 2 diabetes. It influences how the body processes sugar and fat, which might aid in weight control. Early results from similar treatments have demonstrated success in lowering blood sugar levels and promoting weight loss. While specific data for LY3549492 is not yet available, these promising early signs have sparked scientific interest in further investigation. Participants in this trial will receive LY3549492 in one of the treatment groups to evaluate its effectiveness. ^{2 3 5 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 study is for healthy adults who are overweight or have obesity. The trial will last about 8 weeks, and participants must meet specific health criteria to join.

Inclusion Criteria

Hemoglobin A1c level of less than 6.5% at screening

Body mass index (BMI) of 25.0 to 45.0 kg/m² at screening

Participants of childbearing potential must use contraceptives consistent with local regulations

Exclusion Criteria

Supine systolic blood pressure of 160 mmHg or greater, or supine diastolic blood pressure of 100 mmHg or greater, or resting pulse rate of greater than 95 bpm or less than 45 bpm

Serum triglyceride of 5 mmol/L or greater (442 mg/dL) at screening

My obesity is caused by an endocrine disorder like Cushing's or Prader Willi syndrome.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive multiple doses of LY3549492 to assess safety, tolerability, and pharmacokinetics

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3549492

Trial Overview

The trial is testing the safety and effects of multiple doses of a drug called LY3549492 on individuals who are healthy but overweight or obese.

How Is the Trial Designed?

Group I: LY3549492 (Treatment Group 2) Experimental Treatment 1 Intervention

LY3549492 administered orally.

Group II: LY3549492 (Treatment Group 1) Experimental Treatment 1 Intervention

LY3549492 administered 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.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07030868

NCT07030868 | A Study of LY3549492 in Adults With ...

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to evaluate the effects of treatment with LY3549492 ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06683508

NCT06683508 | A Study to Investigate Weight ...

The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to evaluate the effects of LY3549492 in adults with obesity ...

3.

trial.medpath.com

trial.medpath.com/drug/a120434257c33532/ly-3549492

LY-3549492 | MedPath

The development of LY-3549492 as an oral small molecule represents a potentially significant advancement in a therapeutic area currently ...

4.

withpower.com

withpower.com/trial/phase-1-1-2021-2fd8d

LY3549492 for Healthy Volunteers · Info for Participants

Research has shown that LY3549492 is under investigation for its potential benefits in conditions like obesity and type 2 diabetes. In this trial, participants ...

5.

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.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07085468

A Study of LY3549492 in Healthy Weight Adult Participants

Also called a data safety and monitoring board, or DSMB. Early Phase 1 ... The main purpose of this study is to evaluate the safety and tolerability of LY3549492 ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07232732

A Study of LY3549492 in Healthy Participants and ...

The purpose of this study is to see how safe and well-tolerated the drug LY3549492 is and how it behaves in the body, when given in multiple doses to healthy ...