LY3532226 for Obesity

Recruiting at 5 trial locations

Overseen By There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Eli Lilly and Company

Must not be taking: Weight-loss medications

Disqualifiers: Psychiatric disorders, Gastric surgery, others

Compensation: Varies

Number of Visits: Unknown

105 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial requires that you stop taking any weight-loss medications at least 3 months before starting the study. Other medications are not specifically mentioned, so it's best to discuss with the study team.

What makes the drug LY3532226 unique for treating obesity?

LY3532226 is a novel treatment for obesity, potentially offering a new mechanism of action compared to existing drugs like GLP-1 receptor agonists, which are primarily used for diabetes but also help with weight loss. While specific details about LY3532226's mechanism are not provided, its development suggests it may offer a different approach to managing obesity. ^{1 2 3 4 5}

What is the purpose of this trial?

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with obesity. Blood tests will be performed to check how much LY3532226 gets into the bloodstream and how long it takes the body to eliminate it following weekly or monthly administration. Part A of the study will last approximately 16 weeks, excluding screening period. Part B of the study will last approximately 20 weeks, excluding the screening period.

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 individuals with obesity. Specific details about who can join are not provided, but typically participants must meet certain health criteria and be willing to follow the study procedures.

Inclusion Criteria

My weight is under 330 lbs and my BMI is between 30 and 40.

Had a stable body weight with less than or equal to 5% change for 3 months prior to screening and enrollment

Exclusion Criteria

Baseline Patient Health Questionnaire-9 (PHQ-9) score of 15 or greater, and/or a score of 2 or greater for either of the first 2 questions on the PHQ-9 questionnaire

I have a known issue with how my stomach empties or have had certain types of weight loss surgery.

I plan to use weight-loss medications while in the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants receive LY3532226 or placebo subcutaneously to evaluate safety and tolerability

16 weeks

Treatment Part B

Participants receive LY3532226 or placebo subcutaneously to evaluate safety and tolerability

20 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• LY3532226

Trial Overview The study is testing LY3532226, a new potential treatment for obesity. Participants will receive either this drug or a placebo through weekly or monthly doses to evaluate its safety and how it's processed by the body.

Participant Groups

Group I: LY3532226 (Part B) Experimental Treatment 1 Intervention

LY3532226 administered SC

Group II: LY3532226 (Part A) Experimental Treatment 1 Intervention

LY3532226 administered subcutaneously (SC)

Group III: Placebo (Part A) Placebo Group 1 Intervention

Placebo administered SC

Group IV: Placebo (Part B) Placebo Group 1 Intervention

Placebo 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

Findings from Research

Liraglutide, a GLP-1 receptor agonist, is effective for weight loss in overweight or obese patients, showing greater weight reduction compared to placebo and orlistat, particularly at a dosage of 3 mg daily.

In addition to weight loss, liraglutide has been associated with significant health improvements, including reductions in waist circumference, blood pressure, and better lipid profiles, making it a beneficial option for patients with or without type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liraglutide, GLP-1 receptor agonist, for chronic weight loss. Moore, KG., Shealy, K., Clements, JN.[2022]

Obesity is a significant health issue linked to serious conditions like type 2 diabetes and cardiovascular disease, making effective treatment crucial for reducing related health risks.

Recent anti-obesity medications, such as phentermine/topiramate and lorcaserin, target biological mechanisms to suppress appetite and regulate body weight, offering more effective weight loss options for individuals with a BMI over 30 or those with related health conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current updates in the medical management of obesity. Khan, A., Raza, S., Khan, Y., et al.[2019]

HSG4112, an optimized analog of glabridin, was found to be more effective and stable than glabridin in promoting weight loss in obese mice, demonstrating significant improvements in obesity-related parameters after six weeks of treatment.

The weight loss effects of HSG4112 were primarily due to increased energy expenditure rather than reduced physical activity or food intake, indicating a potential mechanism of action that enhances metabolic rate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discovery and preclinical efficacy of HSG4112, a synthetic structural analog of glabridin, for the treatment of obesity. Choi, LS., Jo, IG., Kang, KS., et al.[2021]

Over one-third of adults in the USA are affected by obesity, which significantly contributes to serious health issues like diabetes and cardiovascular disease, highlighting the need for more aggressive treatment options beyond lifestyle changes.

The review discusses FDA-approved anti-obesity medications, emphasizing their safety and efficacy, and suggests that future research may focus on personalized medicine to improve individual responses to these treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current pharmacotherapy for obesity. Srivastava, G., Apovian, CM.[2022]

GLP-1 receptor agonists (GLP-1RAs), originally developed for type 2 diabetes, are effective for weight loss and are now being considered as treatments for obesity, with liraglutide already approved for this purpose.

While GLP-1RAs generally have a good safety profile, with no serious adverse effects reported, they can cause gastrointestinal side effects like nausea, which may affect patient adherence to treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigational glucagon-like peptide-1 agonists for the treatment of obesity. Tomlinson, B., Hu, M., Zhang, Y., et al.[2017]

References

1. England pubmed.ncbi.nlm.nih.gov

Liraglutide, GLP-1 receptor agonist, for chronic weight loss. [2022]

2. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Current updates in the medical management of obesity. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Discovery and preclinical efficacy of HSG4112, a synthetic structural analog of glabridin, for the treatment of obesity. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Current pharmacotherapy for obesity. [2022]

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

Investigational glucagon-like peptide-1 agonists for the treatment of obesity. [2017]