What side effects are associated with this type of intervention?

Common treatments for obesity, such as GLP-1 receptor agonists and phentermine-topiramate combinations, have several known side effects. GLP-1 receptor agonists, like ExQW, often cause gastrointestinal issues such as nausea and vomiting, and can also lead to decreased appetite. Phentermine-topiramate combinations frequently result in dry mouth, paresthesia, dysgeusia, and disturbances in attention. Both treatments are generally well-tolerated, but they can cause significant adverse events in some individuals, necessitating careful monitoring by healthcare providers.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of obesity, including phentermine-topiramate, liraglutide, and extended-release exenatide. These drugs have been evaluated for their safety, tolerability, pharmacokinetics, and effects on body weight, similar to the ongoing study of LY3541105. Phentermine-topiramate has shown significant weight loss in clinical trials, while liraglutide and exenatide, which are GLP-1 receptor agonists, have also demonstrated efficacy in weight reduction and improved glycemic control. These treatments are typically assessed through randomized controlled trials to ensure their safety and effectiveness in managing obesity.

What other types of research exist?

Promising novel alternatives to LY3541105 for obesity treatment include: <ol> <li>Contrave® (Naltrexone/Bupropion): This combination drug targets the central nervous system to reduce hunger and control cravings.</li> <li>Qsymia® (Phentermine/Topiramate): This combination works by decreasing appetite and increasing the feeling of fullness.</li> <li>Semaglutide: A GLP-1 receptor agonist that has shown significant weight loss effects in clinical trials.</li> <li>Tirzepatide: A dual GIP and GLP-1 receptor agonist that has demonstrated promising weight loss results.</li> <li>Setmelanotide: Targets the melanocortin-4 receptor and is specifically for patients with genetic obesity disorders. These alternatives have shown efficacy in weight reduction and have been evaluated for safety and tolerability.</li> </ol>

← Back to Search

Other

LY3541105 for Obesity

Phase 1

Waitlist Available

Research Sponsored by Eli Lilly and Company

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Have history of diabetes (except gestational diabetes) or current diagnosis of diabetes

Have history or current evidence of a clinically significant cardiovascular condition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up predose through day 43 (part a) & day 64 (part b)

Summary

This trial is testing a new drug called LY3541105 to see if it is safe and well-tolerated. The study involves healthy and overweight participants to understand its effects on different body types. Researchers will take blood samples to see how much of the drug gets into the bloodstream and how long it stays there.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Specific side effects aren't listed but generally include monitoring for any adverse reactions related to safety and tolerability of LY3541105 during the trial period.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Select...

I have a serious heart condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ predose through day 43 (part a) & day 64 (part b)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~predose through day 43 (part a) & day 64 (part b)

This trial's timeline: 3 weeks for screening, Varies for treatment, and predose through day 43 (part a) & day 64 (part b) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Therapeutic procedure

Secondary study objectives

PK: Maximum Observed Concentration (Cmax) of LY3541105

PK: Time of Maximum observed Concentration (Tmax) of LY3541105

Pharmacodynamics (PD): Absolute and Percentage Change from Baseline in Body Weight

+1 more

Trial Design

6Treatment groups

Experimental Treatment

Placebo Group

Group I: LY3541105 (Part C)Experimental Treatment1 Intervention

Escalating doses of LY3541105 administered SC.

Group II: LY3541105 (Part B)Experimental Treatment1 Intervention

Multiple ascending doses of LY3541105 administered SC.

Group III: LY3541105 (Part A)Experimental Treatment1 Intervention

Single ascending doses of LY3541105 administered subcutaneously (SC).

Group IV: Placebo (Part B)Placebo Group1 Intervention

Placebo administered SC.

Group V: Placebo (Part C)Placebo Group1 Intervention

Placebo administered SC.

Group VI: Placebo (Part A)Placebo Group1 Intervention

Placebo administered SC.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

LY3541105

2022

Completed Phase 1

~210

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for obesity often involve pharmacological agents that target appetite regulation and metabolic processes. GLP-1 receptor agonists, such as semaglutide and liraglutide, mimic the incretin hormone GLP-1, which enhances insulin secretion, inhibits glucagon release, and slows gastric emptying, leading to reduced appetite and increased satiety. Phentermine-topiramate combines a sympathomimetic amine that suppresses appetite with an anticonvulsant that promotes a feeling of fullness. These mechanisms are crucial for obesity patients as they directly address the physiological drivers of overeating and weight gain. LY3541105, being studied for its safety, tolerability, pharmacokinetics, and effects on body weight, likely operates through similar pathways to influence body weight, making it a potentially valuable addition to obesity treatment options.

Idalopirdine - a small molecule antagonist of 5-HT6 with therapeutic potential against obesity.Pharmacotherapy of obesity.