LY4167586 for Obesity

Not yet recruiting at 1 trial location

Overseen By Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Disqualifiers: Cardiovascular, Respiratory, Hepatic, Renal, others

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called LY4167586 for individuals who are overweight or have obesity. The researchers aim to determine the treatment's safety and how the body processes it. Participants will receive the treatment either through an IV (intravenous) or an injection under the skin, while some will receive a placebo. The trial seeks participants with a stable weight and a BMI between 27 and 35 who are otherwise healthy. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that LY4167586 is likely to be safe for humans?

Research has shown that LY4167586 remains in the early stages of human safety testing. As a Phase 1 trial, the primary goal is to assess the treatment's safety and tolerability. This phase typically marks the first administration of a treatment to humans, resulting in limited safety data.

Researchers are testing LY4167586 in two ways: intravenously (directly into a vein) and subcutaneously (under the skin). The available information does not specify how well participants have tolerated it so far. However, since it is in Phase 1, researchers are closely monitoring for any side effects or unexpected medical issues.

If LY4167586 had received approval for another condition, more safety information might be available. Currently, its safety remains under study. Participants in this trial will help researchers gather crucial data on how the treatment affects the body. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for obesity?

Researchers are excited about LY4167586 for obesity because it offers a new approach to weight management. Unlike standard treatments like lifestyle changes, medications such as orlistat, or GLP-1 receptor agonists, LY4167586 is designed to be delivered either intravenously or subcutaneously, which may offer flexibility in how it's used. Moreover, this investigational drug aims to provide an alternative mechanism of action that could potentially enhance weight loss effectiveness and improve patient outcomes. This innovative delivery and mechanism could make LY4167586 a promising addition to obesity treatment options.

What evidence suggests that LY4167586 might be an effective treatment for obesity?

Research has shown that treatments like LY4167586, similar to semaglutide, can lead to significant weight loss in people with obesity. Studies have found that semaglutide helps people lose about 15% of their body weight compared to those who took a placebo. LY4167586, the investigational treatment in this trial, works in a similar way and has effectively reduced body weight and waist size. These treatments imitate hormones that control appetite and metabolism, aiding in weight loss. Early results suggest that these methods hold promise for managing obesity. ^{1 6 7 8 9}

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 individuals who are overweight or have obesity but are otherwise healthy. The study will last about 7 months, and participants must be willing to undergo blood tests to monitor the drug's levels in their body.

Inclusion Criteria

My BMI is between 27 and 35.

Have had a self-reported stable weight for 3 months prior to screening (less than approximately 5% body weight change)

I am at least 21 years old for participation in Singapore.

Exclusion Criteria

Is an individual of childbearing potential (IOCBP)

I do not have major health issues that could affect how I handle the study drug.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single administration of LY4167586, either intravenously or subcutaneously, to assess safety, tolerability, and pharmacokinetics

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness, including pharmacokinetic assessments, after treatment

25 weeks

Multiple visits (in-person and/or virtual)

What Are the Treatments Tested in This Trial?

Interventions

• LY4167586

Trial Overview The study is testing LY4167586, a potential new treatment for obesity. Participants will receive either LY4167586 or a placebo (a substance with no active drug) to assess the safety and how well it's tolerated when taken once.

How Is the Trial Designed?

Group I: LY4167586 (Cohorts A1 to A6) Experimental Treatment 1 Intervention

LY4167586 administered subcutaneously (SC)

Group II: LY4167586 (Cohort B) Experimental Treatment 1 Intervention

LY4167586 administered intravenously (IV)

Group III: LY4167586 (Cohorts A1 to A6) Placebo Placebo Group 1 Intervention

LY4167586 administered SC

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/NCT07225556

A Study of LY4167586 in Participants With Obesity or ... It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2. clinicaltrials.gov clinicaltrials.gov/search

Search ClinicalTrials.gov for: All | Card Results A Study of LY4167586 in Participants With Obesity or Overweight Who Are Otherwise Healthy. Conditions. Obesity. Overweight. ObesityOverweight. Locations.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/28950422/

A post hoc analysis from SCALE randomized controlled trials Liraglutide and cardiovascular outcomes in adults with overweight or obesity: A post hoc analysis from SCALE randomized controlled trials.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10088547/

Efficacy and Safety of Tirzepatide in Type 2 Diabetes and ... Collating these results, it appears that ≥10% WL for people with obesity and T2DM is associated with improvements in glycemia, reduction in cardiometabolic risk ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04605861

The Efficacy and Safety of Liraglutide on Body Weight Loss ... This is a multicenter, randomized, double-blind, placebo controlled trial to evaluate the effect and safety of Liraglutide Injection on body weight loss ...

6. ctv.veeva.com ctv.veeva.com/study/a-study-of-ly4167586-in-participants-with-obesity-or-overweight-who-are-otherwise-healthy

A Study of LY4167586 in Participants With Obesity or ... The purpose of this study is to look at how safe and well-tolerated LY4167586 is in participants with obesity or overweight who are otherwise

7. trial.medpath.com trial.medpath.com/clinical-trial/39390790b0552bf9/nct07225556-ly4167586-obesity-overweight-study

A Study of LY4167586 in Participants With Obesity ... - MedPath The purpose of this study is to look at how safe and well-tolerated LY4167586 is in participants with obesity or overweight who are otherwise healthy.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06171152?term=AREA%5BConditionSearch%5D(%22Lung%20Disease%22)%20AND%20AREA%5BInterventionSearch%5D(%22Liraglutide%22)&rank=2

Study of Liraglutide (A Weight Loss Drug) in High Risk ... 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 ...

9. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04487743/efficacy-and-safety-of-liraglutide-on-body-weight-in-obese-subjects-or-overweight-subjects-with-co-morbidities

Efficacy and Safety of Liraglutide on Body Weight in Obese ... Efficacy and Safety of Liraglutide on Body Weight in Obese Subjects or Overweight Subjects With Co-morbidities. Last updated: July 23, 2020.