LY3532226 for Obesity

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test the safety and tolerability of a new drug, LY3532226, for individuals with obesity. Researchers seek to determine how well the body processes this drug when administered weekly or monthly. Participants will be divided into groups, receiving either the drug or a placebo (a substance with no active treatment). This trial suits those with a stable body weight, having experienced no more than a 5% change in the last three months, and a body mass index (BMI) between 30 and 40. 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 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.

Is there any evidence suggesting that LY3532226 is likely to be safe for humans?

Research shows that LY3532226 is being tested for use in people with obesity. Although no final reports on its safety exist yet, ongoing studies examine how well people tolerate it. As this is an early-stage trial, the main goal is to ensure the treatment's safety for humans. Researchers closely monitor for any side effects or problems. If LY3532226 proves unsafe, the study will stop. Joining this trial helps gather important information about its safety for people with obesity. ^{1 2 3 4 5}

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

Researchers are excited about LY3532226 because it offers a fresh approach to tackling obesity. Unlike traditional treatments that often target appetite suppression or metabolic rate adjustments, LY3532226 works by a new mechanism that modulates specific metabolic pathways through subcutaneous administration, potentially leading to more effective and sustained weight loss. This innovative method might provide a more targeted and efficient way to manage obesity compared to existing medications like orlistat, phentermine, or liraglutide. Additionally, the subcutaneous delivery of LY3532226 could enhance its absorption and effectiveness, offering a promising alternative to oral medications.

What evidence suggests that LY3532226 might be an effective treatment for obesity?

Research has shown that medications like liraglutide, known as GLP-1 receptor agonists, can aid in weight loss. These treatments have resulted in more weight loss than a placebo, which contains no active ingredients. LY3532226, the investigational treatment in this trial, targets these receptors to promote weight loss. Although the effectiveness of LY3532226 is still under investigation, the success of similar treatments is promising. Early studies have examined how the body absorbs and processes LY3532226, marking an important first step in confirming its potential for weight loss. ^{1 2 5 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?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

LY3532226 administered SC

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

LY3532226 administered SC

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

LY3532226 administered subcutaneously (SC)

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

Placebo administered SC

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

Placebo administered SC

Group VI: Placebo (Part C) 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

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11585837/

Recent achievements and future directions of anti-obesity ... These data align with the FLOW trial, in which semaglutide 1 mg QW let after 48 weeks of treatment to a 24% reduced the risk of the primary ...

2. globenewswire.com globenewswire.com/news-release/2025/07/14/3114576/28124/en/Obesity-Drug-Pipeline-Analysis-Report-2025-Pfizer-and-Eli-Lilly-Lead-the-Charge-in-Cutting-Edge-Obesity-Research.html

Obesity Drug Pipeline Analysis Report 2025 | Pfizer and Eli The 2025 Obesity Drug Pipeline Report offers insights into recent breakthroughs, clinical trials, and regulatory trends, highlighting the shift ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT07215559

NCT07215559 | A Study of Macupatide (LY3532226) and ... The purpose of this study is to investigate weight reduction with macupatide and eloralintide, alone or in combination, in adult participants with obesity ...

4. trials.lilly.com trials.lilly.com/en-US/trial/527756

A Study of LY3532226 in Participants With Obesity - Lilly Trials The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with obesity.

5. withpower.com withpower.com/trial/phase-1-obesity-7-2024-c714e

LY3532226 for Obesity · Info for Participants Liraglutide, a GLP-1 receptor agonist, is effective for weight loss in overweight or obese patients, showing greater weight reduction compared to placebo and ...

6. clinicalresearch.com clinicalresearch.com/en/find-trials/Study/NCT06557356

A Study of LY3532226 in Participants With Obesity The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY3532226 in participants with obesity.

7. williamblair.com williamblair.com/-/media/downloads/eqr/2025/williamblair_shaping-the-future-innovations-and-trends-in-obesity-treatment.pdf

Innovations and Trends in Obesity Treatment We have compiled and analyzed data generated from both approved and investigational agents in the obesity field. Our aim is to establish this ...