LY3549492 for Healthy Volunteers

Overseen By Gene W Voskuhl

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Obesity, Cardiovascular, Hepatic, Pancreatitis, others

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess the safety and tolerability of the new treatment, LY3549492, in healthy participants. Researchers will conduct blood tests to determine how much of the treatment enters the bloodstream and how the body processes it. Participants will receive either the actual treatment or a placebo (a harmless pill with no effect). Those without major health issues and an HbA1c value below 6.5% at screening may be suitable candidates. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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. It's best to discuss your specific medications with the trial coordinators.

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

Research has shown that LY3549492 has undergone testing in several studies to assess its safety and tolerability. In studies with healthy adults, LY3549492 was generally well-tolerated, with no serious side effects reported. Most side effects, such as mild headaches or stomach discomfort, were not severe.

In individuals with type 2 diabetes, the results were similar. The treatment was well-received, and side effects were mostly mild and manageable. These findings suggest that LY3549492 is generally safe, although ongoing studies continue to monitor its safety in different groups. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about LY3549492 because it offers a fresh approach to treatment by being a novel compound that can be administered orally. Unlike other treatments that might require injections or more invasive methods, LY3549492 is taken by mouth, which can make it more convenient for patients. Additionally, its development as both single and multiple ascending doses suggests flexibility in dosing, potentially optimizing efficacy while minimizing side effects. This innovative approach has the potential to improve patient compliance and overall treatment outcomes.

What evidence suggests that LY3549492 could be effective?

Research has shown that LY3549492 is under investigation for its potential benefits in conditions like obesity and type 2 diabetes. In this trial, participants will receive either LY3549492, administered orally in single or multiple ascending doses, or a placebo. Studies involving adults with type 2 diabetes have demonstrated that LY3549492 affects certain body processes, which might help control blood sugar levels. Another study examined adults with obesity to assess how LY3549492 might aid in weight management. These early results suggest that LY3549492 could play a significant role in treating metabolic issues. However, further research is necessary to fully understand its effects and safety. ^{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 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

Inclusion Criteria

Healthy Males and females (excluding women of childbearing potential at the time of signing the informed consent)

Glycated hemoglobin (HbA1c) value of <6.5% at screening

Body mass index (BMI) within the range 20 to 40 kilograms per square meter (kg/m²), inclusive

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive LY3549492 as single ascending doses

Approximately 4 weeks

Treatment Part B

Participants receive LY3549492 as multiple ascending doses

Approximately 4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Approximately 4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3549492
• Placebo

How Is the Trial Designed?

Group I: LY3549492 (Part B) Experimental Treatment 1 Intervention

LY3549492 administered orally as multiple ascending doses.

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

LY3549492 administered orally as single ascending doses.

Group III: Placebo Placebo Group 1 Intervention

Placebo 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/NCT07085468

A Study of LY3549492 in Healthy Weight Adult Participants A group of independent scientists who monitor the safety and scientific integrity of a clinical trial. The DMC can recommend to the sponsor that the trial be ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07030868

Study of LY3549492 in Adults With Obesity/Type 2 Diabetes The main purpose of this study, performed under the master protocol W8M-MC-CWMM (NCT06143956), is to evaluate the effects of treatment with LY3549492 ...

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. trialx.com trialx.com/clinical-trials/listings/269211/a-study-of-ly3549492-in-participants-with-type-2-diabetes-mellitus-t2dm/

A Study of LY3549492 in Participants With Type 2 Diabetes ... The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in participants with T2DM.

5. trials.lilly.com trials.lilly.com/en-US/trial/554575

Weight Management Study: LY3549492 vs. Placebo 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 ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-of-ly3549492-in-healthy-weight-adult-participants

A Study of LY3549492 in Healthy Weight Adult Participants The main purpose of this study is to evaluate the safety and tolerability of LY3549492 in adult participants with a healthy body max index (BMI) ...

7. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05327595/a-study-of-ly3549492-in-participants-with-type-2-diabetes-mellitus-t2dm

A Study of LY3549492 in Participants With Type 2 Diabetes ... This study evaluates the safety and tolerability of LY3549492 in T2DM participants, checking how the body handles it, and lasts 12-13 weeks.