LY3541105 for Obesity

No longer recruiting at 1 trial location

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

Disqualifiers: Diabetes, Cardiovascular conditions, others

Compensation: Varies

Number of Visits: 38

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the safety and tolerability of a new treatment called LY3541105 in individuals who are overweight or healthy. Researchers aim to assess how LY3541105 affects body weight and its processing in the body. Participants will receive either LY3541105 or a placebo (a harmless pill with no active drug), and the study will explore different doses to determine the optimal one. Individuals who have maintained a stable weight over the past 3 months and have a BMI (a measure of body fat based on height and weight) between 18.5 and 40 may be suitable for this trial. As a Phase 1 trial, this research seeks to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

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 this trial's treatments are likely to be safe?

Research shows that LY3541105 mimics amylin, a hormone that helps control body weight. Early studies are testing LY3541105 to determine its safety and tolerability in healthy and overweight individuals. Although specific results from these studies are not yet available, testing at this stage suggests some initial evidence of safety. Researchers are currently identifying any side effects and assessing how well the body handles the treatment. They closely monitor participants for any negative or unexpected reactions. ^{1 2 3 4 5}

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

Researchers are excited about LY3541105 for obesity because it works differently than most existing treatments. While many current options focus on appetite suppression or calorie absorption, LY3541105 operates through a novel mechanism that involves escalating doses administered subcutaneously, which could offer a more targeted and efficient approach. This unique delivery method might also improve patient compliance and potentially provide faster and more sustained results. By exploring these innovative features, LY3541105 holds the promise of advancing obesity management in a way that current treatments do not.

What evidence suggests that LY3541105 might be an effective treatment for obesity?

Research shows that LY3541105 is a promising new treatment for obesity. It affects three specific parts of the body that control energy use. Early studies in obese mice showed that LY3541105 led to significant weight loss. Although direct human data remains limited, its mechanism suggests potential effectiveness for people. Participants in this trial will receive either LY3541105 or a placebo. This treatment might offer a new way to manage weight by influencing the body's energy use. ^{1 3 4 5 6}

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 healthy or overweight men and women who are not able to have children. Men must agree not to donate sperm and use contraception. Participants should have a stable weight for the past 3 months, with BMIs of 18.5-32 kg/m² in Part A or 27-40 kg/m² in Part B.

Inclusion Criteria

I am a man who agrees not to donate sperm and to use contraception, or I am a woman who cannot become pregnant.

Participants who are overtly healthy as determined by medical evaluation

You have a body mass index (BMI) in the range of greater than or equal to (>/=) 18.

Exclusion Criteria

I have diabetes, but it's not just from pregnancy.

Clinically significant abnormal electrocardiogram (ECG) at screening, as judged by the Investigator

I have a serious heart condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Single ascending doses of LY3541105 administered subcutaneously

15 weeks

Up to 7 visits

Treatment Part B

Multiple ascending doses of LY3541105 administered subcutaneously

26 weeks

Up to 15 visits

Treatment Part C

Escalating doses of LY3541105 administered subcutaneously

24 weeks

Up to 16 visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• LY3541105
• Placebo

Trial Overview

The study tests LY3541105's safety and how it affects body weight compared to a placebo. It checks how much drug gets into the blood, its elimination rate, and involves two parts lasting up to 15 weeks (Part A) or up to 26 weeks (Part B), with several visits.

How Is the Trial Designed?

Group I: LY3541105 (Part C) Experimental Treatment 1 Intervention

Escalating doses of LY3541105 administered SC.

Group II: LY3541105 (Part B) Experimental Treatment 1 Intervention

Multiple ascending doses of LY3541105 administered SC.

Group III: LY3541105 (Part A) Experimental Treatment 1 Intervention

Single ascending doses of LY3541105 administered subcutaneously (SC).

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

Placebo administered SC.

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

Placebo administered SC.

Group VI: Placebo (Part A) 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

LY3437943 is a novel triple agonist that targets three receptors related to metabolism, showing promising results in obese mice by reducing body weight and improving blood sugar control.

In a phase 1 study, LY3437943 demonstrated a safety profile similar to existing treatments and supported once-weekly dosing, with weight loss effects lasting up to 43 days after a single dose.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

LY3437943, a novel triple glucagon, GIP, and GLP-1 receptor agonist for glycemic control and weight loss: From discovery to clinical proof of concept. Coskun, T., Urva, S., Roell, WC., et al.[2022]

Combination therapies for obesity treatment, such as pramlintide with phentermine and GLP-1 with glucagon, show promising efficacy beyond traditional diet and lifestyle changes.

Recent trials indicate that combining intragastric balloon treatments with GLP-1 analogs like liraglutide may enhance weight loss outcomes, suggesting a potential new direction for obesity management in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combination Therapies for Obesity. Camilleri, M., Acosta, A.[2019]

In a 16-week study involving 140 overweight adults, the herbal extract LI85008F led to significant weight loss (5.36 kg) and reductions in BMI compared to a placebo group, indicating its efficacy for weight management.

Participants taking LI85008F also experienced improvements in their lipid profiles, with decreased LDL cholesterol and increased HDL cholesterol, and no major adverse events were reported, highlighting its safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a novel herbal formulation for weight loss demonstrated in a 16-week randomized, double-blind, placebo-controlled clinical trial with healthy overweight adults. Dixit, K., Kamath, DV., Alluri, KV., et al.[2019]

The combination of phentermine and topiramate is currently the most effective FDA-approved treatment for obesity, followed by lorcaserin and bupropion/naltrexone.

Effective obesity management should consider not only medication efficacy but also comorbidities, drug interactions, and personalized treatment approaches based on individual genetic profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Precision Obesity Treatments Including Pharmacogenetic and Nutrigenetic Approaches. Solas, M., Milagro, FI., Martínez-Urbistondo, D., et al.[2018]

Bariatric surgery remains the most effective treatment for obesity, but it can lead to nutritional and metabolic complications that are not fully understood.

The review highlights the efficacy and safety of several novel weight-loss drugs, including lorcaserin, tesofensine, and liraglutide, which are being evaluated for market approval, addressing the need for more effective antiobesity agents due to the limited options currently available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Recent progress and novel perspectives on obesity pharmacotherapy]. Faria, AM., Mancini, MC., Melo, ME., et al.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05380323

A Study of LY3541105 in Healthy and Overweight ...

It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2.

withpower.com

withpower.com/trial/phase-1-healthy-subjects-hs-4-2022-826fd

LY3541105 for Obesity · Info for Participants

LY3437943 is a novel triple agonist that targets three receptors related to metabolism, showing promising results in obese mice by reducing body weight and ...

3.

iqvia.com

iqvia.com/-/media/iqvia/pdfs/library/articles/obesity-key-pipeline-developments-and-clinical-trial-insights.pdf

Obesity: Key Pipeline Developments and Clinical Trial ...

15 The TIPO-1 trial (NCT00394667) demonstrated that a daily oral dose of 0.50 mg of tesofensine resulted in significant weight loss.

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11642516/

Approved and Emerging Hormone-Based Anti-Obesity ...

Our review provides a comprehensive overview of the approved and emerging hormone-based AOMs, highlighting the diversity of options that might become available ...

5.

medical.lilly.com

medical.lilly.com/us/science/conferences/obesity/eco2025

Welcome to the Lilly Scientific Information Page for ECO 2025

Tirzepatide vs Semaglutide for the Management of Obesity and Overweight: A Subgroup Indirect Treatment Comparison of Body Composition Outcomes

6.

medchemexpress.com

medchemexpress.com/colulintide.html?srsltid=AfmBOoodVQMjGpiw-yBoPjn5yR387aBZanV3zP1wvUt5m89QVc4pRfuJ

Colulintide (LY3541105) | Amylin Functional Analogue

Colulintide is a functional analog of amylin that can be used in obesity research. For research use only. We do not sell to patients.